Medical Device Resume Samples

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Guide the recruiter to the conclusion that you are the best candidate for the medical device job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

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M Romaguera

Mack

Romaguera

68776 Conn Avenue

Phoenix

+1 (555) 357 7149

68776 Conn Avenue

Phoenix

Phone

p +1 (555) 357 7149

Experience Experience

Boston, MA

Medical Device

Boston, MA

Nikolaus-Medhurst

Boston, MA

Medical Device

Provide input to line managers of project team members' performance relative to project tasks
Management reporting and ensure the timely delivery of different testing milestones, daily management of the software teams (scrum master)
Responsible for development and test operations – design, plan and execute
Collect information on team performance against contract, customer expectations, and project baselines
Supporting the development of a subject recruitment plan
Manage project budgets
Participate in proposal development and sales/proposal presentations

Chicago, IL

Medical Device Operator

Chicago, IL

Kerluke-Nitzsche

Chicago, IL

Medical Device Operator

Working with EH & S and engineering to assure a safe work environment
Working with EH&S and engineering to assure a safe work environment
Performing data collection and entry
Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
Performing data collection/computer entry
Working in a cleanroom manufacturing environment
Performing hand assembly and visual inspection

present

Boston, MA

Medical Device Package Manager

Boston, MA

Reinger, VonRueden and Bernhard

present

Boston, MA

Medical Device Package Manager

present

Responsibly manage data in Laboratory Information Management Systems (LIMS) and Laboratory Notebooks
Develop/improve processes in the Package Testing Lab
Assist in equipment qualification and development of SOPs
Assist in receipt/storage of customer samples
Performs other duties as assigned
Provide Medical Device packaging expertise to internal/external customers
Develop technical reports of test results following defined documentation procedures

Education Education

Bachelor’s Degree in Related Field

Boston University

Bachelor’s Degree in Related Field

Skills Skills

Able to think analytically and to draw conclusions, possess strong analytical skills, with excellent problem solving abilities
Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior
Proven ability to create a high performance culture which fosters On-Time-Delivery with Quality and Content
Solid verbal and written communication skills and able to take decisions even under pressure
Operational mind-set with focus on deadlines, detail and quality oriented
Organized and persistent: Able to prioritize, organize and get things done. Good at executing
Possess strong analytical skills, with excellent problem solving abilities
Ability to act as a technical driver for the rest of the team. Solid verbal and written communication skills
Ability to work independently and as a team member
Ability and aptitude to use various types of databases and other computer software

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15 Medical Device resume templates

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Lead-external Medical Device Mfg Resume Examples & Samples

Lead external manufacturing cross functional teams with key business partners for medical device, combination product, and pharmaceutical products through clinical development, product registration and commercialization
Expertise in design controls, biocompatibility, sterilization validation, packaging validation, and shelf life stability programs
Works closely with the procurement team on contract vendor selection, outsourcing models, and vendor evaluation audits, for medical device partners and combination products
Establishing and fostering strong collaborative relationships with external design/development, manufacturing partners and service providers
Change owner for manufacturing vendor change notifications; lead or assists with manufacturing deviations, customer complaints and product failure investigations
Establish and maintain detailed project plans; define risks and recommend contingency plans as required
More than 10 years of experience in the field of medical devices or combination products development and commercialization is required
A Bachelors of Science Degree in Engineering, Biotechnology, or Life Science is required
A Masters of Science Degree or Masters of Business Administration preferred
Minimum of 5 years managing contractors and leading projects
Experience in developing and commercializing FDA regulated devices / combination products under design control regulations
Experience in supply chain handling, clinical manufacturing and distribution
Knowledge of industry standards (e.g.: ISO, AAMI, ANSI)
Strong managerial leadership skills with a track record of delivering new products to market with development partners
Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders

Medical Device Production Manager Resume Examples & Samples

Be responsible for the delivery of quality products on time to meet market demands
To implement and manage all manufacturing activity in compliance with company and ISO quality standards
To supervise the production personnel within the production area by administering company policies and procedures. Perform: hiring, job assignments, promotions, salary actions, disciplinary actions, and process performance reviews
To motivate and manage staff towards achievement of targets and objectives on an ongoing basis
Monitor and manage production costs and implement continuous improvement to increase capabilities and capacity of the manufacturing unit
Liaise directly with the material planner, suppliers and internal fabrication departments to ensure effective production levels
To liaise with design teams and engineering managers in support of New Product Introductions(NPI) and sustaining engineering activities
Provide regular production metric reports to the company management
Train production staff through effective leadership and coaching skills
Create and manage an overall Operations budget
Manage and control material inventory
Have created/established a manufacturing facility
A proven track record of managing a production team within high technology instrument manufacturing
Experience of staff management, appraisal, development and planning
Qualification in skills of project management and can demonstrate the application of these skills to management
Ability to motivate people and have strong communication skills
Knowledge and application of LEAN manufacturing principles to to implement continuous improvement techniques
Good interpersonal skills - able to express ideas, recognize good ideas and collaborate with cross-functional teams. Communication project status
Have an ability to plan, organize production and coordinate production to a high level
Basic knowledge of 3D CAD preferably Pro/ENGINEER would be advantageous
Six sigma green belt/black belt certified
Demonstrated ability to use process and quality control statistical methods to identify and correct/improve production processes

Finance Manager, Medical Device MNC Resume Examples & Samples

More than 8-years' experience in accounting and finance roles, with increasing levels of responsibility
Maintenance of Accounting certification, preferably US CPA, Australia CA, ACCA, or equivalent
Proficiency with SAP or other ERP system and with Excel, including pivot tables, lookups and other key functions
Knowledge of Philippines statutory and tax reporting requirements
Experience with US GAAP and Sarbanes-Oxley requirements
Firm commitment to professional standards and ethics
Curiosity attitude and possess strong business acumen

R & D Medical Device Engineer Resume Examples & Samples

Degree in Engineering (mechanical/electronics or industrial)
Experience within a Quality/GMP regulated industry
Process validation and manufacturing experience desirable
Polymer Science and/or Injection Moulding desirable
3D spatial awareness and visualisation of concepts, mechanisms and assemblies
Ability to work in a team and on your own
Analytical approach to potential problems and opportunities
Good communication skills and initiative
Ability to meet challenging timelines
Keen to develop new areas of knowledge

Medical Device Marketing Leadership Opportunities Resume Examples & Samples

Brand Strategy
Consumer Insights & Analytics
Product Launch
Marketing Communication
Marketing Planning & Execution
Global Innovation & Pipeline

Medical Device / Systems Analyst Resume Examples & Samples

Analyze and investigate issues
Provides explanations and interpretations within area of expertise
Investigate non - standard requests and problems
Document and keep logs of past and current state
On - Call support on rotation
1+ year of Helpdesk related experience
3+ year supporting networked Windows PCs with external devices
3+ years Wired / wireless device configuration
1+ year Quality Assurance Testing experience
Basic level with MS Word, Access, Excel
Previous experience with issue research / resolution and error management in clinical applications and devices
Capable of providing own reliable transportation for local travel to specified sites to troubleshoot
Willing and able to work in an on - call rotation
Medical Device support - MRI, EKG, Mammography, X-Ray, etc
Network issue resolution
Previous experience with clinical and transcription related applications (Fuji / Synapse, PowerScribe, Vericis / Pyramis, Allscripts Enterprise, GE Centricity Business, and
GE Centricity RIS
Experience documenting workflows
Basic level with MS Office Visio

Medical Device Technical Specialist Resume Examples & Samples

Schedule, plan, perform and report audits of clients’ management systems to ensure compliance with regulatory and voluntary requirements
Assess and report on the sterility assurance aspects of medical device technical documentation and quality systems
Attend assessments as technical expert or provide expert briefing
Review critical data (including sterilization validation), routinely at the cutting edge of technology where no product standards or device experience exists, identify when additional external expertise is required, make safe recommendations for the issuing of BSI certificates
Deliver Medical Device CE Marking technical review, scheme management and ISO 13485 QMS assessment services as a fully integrated member of the Microbiology Team
Work with other team leaders as required to provide QMS assessment within area of expertise
Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge
Provide appropriate “Technical Sales/Networking” support to the commercial team
A degree-level qualification in Microbiology or equivalent biological science
Experience and successful completion of training in the routine control and validation of sterilization and microbiological testing (Aseptic fill may be accepted in lieu)
A minimum of three years’ experience in the medical device or pharmaceutical field
Hands-on experience of working as a microbiologist in the manufacture of sterile products
Thorough knowledge of Medical Device regulation
An appreciation of the concepts and intent of Product Certification and service orientation
Knowledge of business processes and the application of quality management standards
Conceptual and analytical thinking, with a keen focus on efficiency and delivering the right results
Team player mind-set and a proven track record of building good relationships, both internally and externally
Broad technical understanding of client industry products
Strong communications skills - fluent English is essential, additional languages a plus

Medical Device Test Lead Resume Examples & Samples

8 - 10 years of experience in Medical device product verification, Regulatory compliance, Risk Management and SW Hazard analysis activities for Class I, II and Class III medical devices against FDA QSR 820, ISO 13485, AAMI TIR 45, FDA Validation guidance and IEC 62304 and GAMP-5 Computer System Validation (CSV)
Experience in EU Medical Device regulations and CE marking process and related SOP creation
Experience in working with Notified bodies and work experience in handling ISO 13485, EU notified body audits
Experience in ensuring Design Control compliance and Design History file( DHF) maintenance
Expertise in Test Management, Design verification Strategy and Planning, test execution, Regression test strategy, Design verification summary report ,defect report documentations and onsite-offshore coordination
Developed the SOPs for Design Verification, Validation, Design Output activities in line with FDA medical device regulations and IEC 62304

Medical Device Test Developer Resume Examples & Samples

3-5 Years of Experience, with 1+ years of experience in Medical device testing
Knowledge or working experience in Automation
Experience working within a SCRUM/Agile environment

Medical Device Test Manager Resume Examples & Samples

13+ years relevant experience , with 5+ years experience in Medical domain/ Medical device testing
Experience in SDLC and ALM
Knowledge of C#, C++ and VB
Windows test automation and automation framework implementation
Experience with Microsoft Team Foundation Server, Microsoft Test Manager, and MS tools
Knowledge or working experience in Coded UI Test

Medical Device IT Verification Engineer Resume Examples & Samples

Four-year Engineering degree (BE/BTech) in Information Systems, Computer Science or equivalent
2-8 years of experience in IT industry as technical support, technical trouble shooter/bug fixer; experience as development engineer will be added advantage
Strong analytical and problem solving skills, you thrive on solving complex technical problems
Certification in testing tools or testing skills desirable, good understanding of statistics would be positive
Minimum of 70 % aggregate in graduation, XII and X standards
Knowledge of structured testing methods and processes, knowledge of several aspects of SW development concepts
Experience with communication standards e.g. ASTM, HL7, POCT1-A. (preferred)
Experience with integration engines like Microsoft BizTalk or Mirth. (preferred)
Experience in creating and maintaining reports using SQL Server Reporting Services (SSRS). (preferred)
Outspoken and with excellent communication skills. Strong customer focus and ability to interact with customers across the different regions in the world
Experience with medical device SW or experience from health care section is an advantage

Medical Device Test Lead Resume Examples & Samples

5+ years relevant experience (BE/BTech), 3+ years relevant experience (MSc)
Proactive and self driven
Strong testing , trouble shooting and problem solving skills
Knowledge of C#
Windows test automation

Medical Device IT Test Developer Resume Examples & Samples

Responsible for SW features designing and implementation for MS Windows web services of the next generation acute care management of medical device
Four-year-degree (BE/BTech) in computer science, computer engineering, software engineering or equivalent
Certification in testing tools or testing skills desirable
0-2 years relevant experience
Skillset: .NET developer (C#)
Test automation : Coded UI testing, Performance and scalability testing (Web performance testing), Security testing
Strong in MS tools and technologies : Microsoft Test Manager (MTM), Test Lab Center (lab environment), SCVMM (Hyper V environments)
Knowledge of SQL, Reporting service, Windows server, MSI, WMI and MMC
Structured and methodical, Excellent analytical skills and communication skills
Hands-on experience from several aspects of SW development

Medical Device IT Test Developer Resume Examples & Samples

Daily management of CI. Reporting to various project stakeholders
Participate in project-wide reviews of requirements, system architecture, and detailed design documents. Participate effectively in estimation, planning, cost-of-quality, and quality risk analysis is desired
Perform static analysis of source code using complexity metrics
Ensuring full compliance with relevant work practices, as required by authorities for medical device product development
Ensuring full compliance with Radiometers quality system
5+ years relevant experience, Certification in testing tools or testing skills desirable
Must have relevant experience in manual SW Test execution, understanding testing environment (MS Server, SQL). Good knowledge of Web testing (HTML, Browsers), and capable of tracing SW work flow
Hands-on experience with MS tools and technologies such as Microsoft Test Manager (MTM), TFS
Experience of working in agile development methodologies with understanding of several aspects of SW development processes
Possess good analytical skills, with excellent problem solving abilities
Technical knowledge and experience, ideally in areas of software development for clinical and medical device development

Medical Device Engineer Resume Examples & Samples

Develop and validate test methods to support activities related to the selection, characterization, design verification, and commercialization and marketing of various drug delivery devices and novel injection tools for biologic therapeutics
Provide leadership in the validation of mechanical test methods
Review and validate mechanical test methods
Author method validation protocols and reports, and test methods
Initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems
Work with limited direction and provide guidance and coordinate work activities of other personnel
Experience with mechanical testing methods (e.g. Instron) and test method validation as well as design controls for regulatory compliance and filing
Experience with data and statistical analysis (JMP, Minitab), DOE, and measurement system analysis (e.g. Gage R&R)
Strong organizational, communication, and interpersonal skills. Team oriented, dependable, self-starter. Strong computer and scientific skills. Excellent oral and written communication skills
Ability to work independently and as part of a team, self-motivation, adaptability, and with a positive attitude
Ability to learn new skills, perform multiple tasks simultaneously, attention to detail, keep accurate records, follow instructions, and comply with company policies
Bachelor's or Master’s degree in Engineering, or other related degree concentration with 10 years of experience in method validation
Experience in software validation desirable

Principal Engineer, Medical Device Resume Examples & Samples

BS Degree in Engineering, MS Degree preferred
10 or more years of Medical Device Industry experience, including project management and development of drug device combination products
Profound knowledge of mechanical design and precision engineering for mechanic devices
Strong knowledge and professional experience in medical device development processes and applicable regulatory requirements
Significant working experience in multiple phases of the Engineering Lifecycle: design, prototyping, manufacturing, testing, process / design improvements
Relative experience with tooling / molding, assembly, testing (mechanical, performance, transportation) and packaging processes
Experience with providing leadership to international, cross-functional expert teams
Ability to facilitate decision making in a challenging environment
Fluent in English, German is a plus
Open and transparent communication style. ~BSP
Systematic, proactive and efficient working style. #LI-SA

Medical Device Program Manager Resume Examples & Samples

Advanced degree (MS, PhD, MBA) in engineering or business/management field
Project Management Professional (PMP) certification
Experience working within medical device development Quality Systems. (ISO 13485, 90001, etc)
Experience across the medical device development continuum, from concept development activities through product launch

Lead Medical Device Intergration Resume Examples & Samples

Minimum six (6) years of related experience
Minimum of 6 years work experience in healthcare IT or equivalent
1 year of experience or formal course work with Microsoft Server 2003 (or later) environment
Be willing to Travel to KP sites as needed (approximate 5% travel expected)
Be available for an on call rotation basis, this includes weekends and holidays
Good written and oral communication skills (documentation creation is involved)
MCSE
Web App familiarity
Facilitate OS & database upgrades
Medical Device application experience
SharePoint Experience

Senior.medical Device Engineer Resume Examples & Samples

Minimum four (4) years of related experience
Minimum of 4 years work experience in healthcare IT or equivalent
Exceptional application analysis and design skills, as well as thorough trouble-shooting capabilities
Ability to lead a team in dynamic and rapidly changing environment
Tivoli experience

Medical Device Engineer, Sterile Products Resume Examples & Samples

Design and implementation of silicone and thermoplastic parts
Design of medical devices, including assembly and system integration, packaging, labeling, sterilization and related processing
Create design documentation, including requirements, specifications and process documentation (instructions, procedures, BOMs, etc)
Provide support for design verification and validation
Define and execute process qualification documents (PFMEA, PVP, TMV, IQ, OQ, PQ, etc)
Participate in medical device projects and provide project leadership on medical device development projects with primary mechanical design and production transfer responsibilities
Participate in medical device design reviews as project leader, participant and independent reviewer, as applicable
Provide manufacturing and production support of UT companies and partner locations
Proficient in Microsoft Office; Word, Excel, Access, Visio and Outlook
Prior experience with sterile product design, manufacture and packaging, and related standards
Advanced proficiency in Solidworks
Experience applying statistical analysis using analytical packages (MiniTab, Mathmatica, etc)
Proficient in ERP/MRP systems required related to Master data, BOM’s, production workflows and related topics

Medical Device Operator Resume Examples & Samples

Be passionate about providing manufacturing state-of-the art implantable medical devices
Working in a cleanroom manufacturing environment
Setting up and operating equipment
Performing data collection and entry
Following standard operating procedures (SOPs)
Manufacturing product with timeliness and accuracy
Making detailed and accurate observations
Working with EH & S and engineering to assure a safe work environment
Adapting and demonstrating flexibility by moving from one manufacturing area to another as needed
Manufacturing experience with small parts assembly
Excellent hand-eye coordination and fine motor skills
Extremely detail-oriented and organized
Superior accuracy in following written instructions
Effective communication skills, both verbal and written, with a demonstrated ability to positively influence teammates
Proven ability to set priorities
Flexibility to adapt and change to meet manufacturing and R&D needs
Possession of basic computer and math skills
Ability to

Medical Device Operator Resume Examples & Samples

Working with EH&S and engineering to assure a safe work environment
Flexibility to adapt and change to meet manufacturing needs
Experience initiating and completing projects
Leadership experience, including leading and sponsoring others
E1 experience

Medical Device Lead Auditors Resume Examples & Samples

To plan and conduct professional management system audits in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards
To assist in business development as required and to provide specific technical support to expand the Company’s capability to offer valued services to customers
To carry out specific project tasks in relation to medical devices procedures, processes, systems and documentation
Conduct Technical Files review specific for products being authorized for
Provide accurate and timely reporting as required by line management to assist the planning and management of operations
If required undertake reviews of packs and make certification decisions within target timescales and in line with SGS policies and accreditation/approval requirements
Manage personal schedule to work efficiently and to meet target chargeability requirements as defined by the Certification Manager
Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant auditor registrations and relevant industry knowledge
Support business development activities as required (including follow up and/or referral of enquiries, sales visits, assistance at events, seminars, etc) to enable on-going growth of the business
Carry out internal audits of individual auditors, functions or offices to ensure internal compliance with relevant standards
Must be able to demonstrate and excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques (Essential)
Must be able to demonstrate a good knowledge of
Electro-medical devices (active devices); and/or sterilization and non active devices
Good experience with EN ISO 60601-1 3rd Edition and relative amendment; and/or Harmonised sterilization and cleanroom and on active medical device standards
Good experience with Risk Management EN ISO 14971:2012
Good knowledge of ISO 13485, MDD 93/42/EEC and their application
Good knowledge of Usability / Software standards such as 60601-1-6, 62366, 62304 and/or clean room and sterilization product standards
Effective interpersonal skills; able to develop good working relationships with people at all levels (Essential)
Must be IT literate i.e. competent in the use of MS Office applications and preferable experience of using large and complex databases (Essential)
Willingness to learn and adapt to change – committed to continuous personal and professional development (Essential)
Must have a detailed understanding of the relevant medical device regulations for with audits/technical reviews are being undertaken (Essential)
Must be currently working for or have worked for a Notified body as a Medical Device lead auditor within the last 6 months
Ideally able to demonstrate ability to identify and capitalise on any potential to maximise sales/revenue generated by the business (Desirable)
Able to motivate and lead others in a ‘project team’ environment (Desirable)
Work experience in positions with significant QA or management systems responsibility(Essential)
Medical device experience from auditing/work ( Essential)
Experience auditing against recognised standards (Essential)
Experience of working under own initiative and in planning and prioritising workloads (Essential)
Experience as a medical device lead auditor working for a notified body (Essential)
Experience of reviewing audit packs ( desirable)
GCSE Mathematics & English Language, or equivalent (Essential)
First degree, or equivalent vocational qualifications - i.e. BA/BSc, HND, Chartered Engineer, diploma etc (Essential)
Registered IRCA lead auditor, or equivalent registration under other recognised body (Desirable on entry, Essential within one year)

Medical Device Principal Engineer Resume Examples & Samples

Support overall project management, including software development, scope management, and release planning
Participate in the execution, documentation, review, and approval of all processes in the Software Development Life Cycle
Implement software designs for isolation of critical path or safety critical design elements
Review complex software design concepts prior to implementation
Participate in the integration of software implementations with system interfaces
Approve supporting documentation in order to secure project release
Anticipate project challenges and risk scenarios
Identify and execute proactive mitigation strategies to ensure optimal results
B.S. in Software Engineering, Computer & Electrical Engineering, Computer Science or related field
Required: 7+ years’ experience within and FDA regulated medical device industry
Well versed in software engineering disciplines with working knowledge of cGMPs and applicable industry standards
Thorough understanding of the Software Development Life Cycle (SDLC)
Experience integrating software and hardware, particularly in an embedded context
Experience reviewing, porting, and integrating third-party code, and using application frameworks
Intensive experience in micro-controller programming, preferably using 8051 & AVR RISC architectures
Familiarity with standard OS features (e.g. threading and concurrency, memory management, device drivers, I/O, etc.)
Strong C/C++ programming skills
Working experience with embedded RTOS preferred
Intensive familiarity with QNX or UNIX/Linux preferred
Experience in GUI application design
Experience in algorithm development, mathematical transformations, and protocol formulation preferred
Well versed in Design Control, Risk Analysis, Change Control, and problem solving (CAPA) preferred
Experience presenting concepts to a broad range of audiences from executives to software developers
Proven track record of software development effectiveness; leadership preferred

Medical Device Technician Resume Examples & Samples

Follows established department procedures to accurately verify and deliver the proper equipment by visually checking department requests and obtaining a verbal verification as needed
Delivers and/or sets up required equipment at various patient care areas throughout the hospital in a safe and efficient manner
Reports to the nursing unit and notifies nursing staff of equipment being delivered and/or pickup up and records delivery and/or pick up
Initiates or assists in transfer process of equipment from or to the Distribution department
Communicates to supervisor the completion of assigned duties and proceeds as instructed. If a delay or problem occurs in delivery of equipment, Distributor informs supervisor immediately and proceeds according to instructions issued
Provides directions and other helpful information to visitors and others while performing distribution duties
Returns equipment promptly to the appropriate area after pick-up and performs proper cleaning and infection control procedures. Performs basic operational check on all equipment made ready for distribution
Dresses in accordance with the dress code while adhering to proper hygiene when reporting for work and performing job duties
Adheres to the established policies addressing the confidentiality of patient information
Displays positive working relations with team members and customers throughout the hospital, communicating positively and appropriately
Assists in training new employees
Must be able to read, write, comprehend, and communicate the English language
Positive, helpful attitude toward customers
Ability to remain calm in less than calm circumstances
Flexibility, versatility, and reliability as a team player

Medical Device Prior Authorization Resume Examples & Samples

HS Diploma, GED, or technical certification in related field or equivalent experience
3+ years experience in related field
Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments
In-depth knowledge in technical or specialty area
Applies advanced skills to resolve complex problems independently
May modify process to resolve situations
Works independently within established procedures; may receive general guidance on new assignments
May provide general guidance or technical assistance to less experienced team members

Medical Device Operator Resume Examples & Samples

Working standard weekly hours: Monday through Thursday 3:15 p.m. - 12:15 a.m. and Friday 10:00 a.m. - 2:00 p.m., Monday through Friday or 3:15 p.m. - 11:15 p.m. (8-hour days)
Excellent track record of attendance
Understanding of manufacturing computer systems (i.e. Agile, MES and E1)
Experience working in a regulated industry

External Engineer Medical Device Company Resume Examples & Samples

Requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study
Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements
Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues
Demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills

Medical Device Analyst Resume Examples & Samples

Initiates and manages the complaint file
Maintains accurate entry of complaints in the database
Communicates to field representatives regarding information needed specific to products complaints (e.g. physicians, hospital personnel, sales representatives, international offices)
Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA)
Submits reports within required time frame
Diligent of any unusual trends in product complaints and communicates them with mgmt
Complies with US FDA regulations, other regulatory requirements

Medical Device Engineer Resume Examples & Samples

Will assist with the gap analysis on Design History Files
Completing the action items driven from the gap analysis, including conducting mechanical testing, updating drawings, conducting tolerance stack analysis, writing inspection procedures
Bachelor Degree in Biomedical Engineering, Mechanical Engineering or related field
2+ years in development of implantable medical devices
Solidworks experience is a must

Medical Device Operator Resume Examples & Samples

Be passionate about manufacturing products that are the highest quality in their class
Working within a team in a controlled/clean-room manufacturing environment while wearing required clean-room garments
Setting up and operating manufacturing equipment
Performing hand assembly and visual inspection
Using measuring equipment
Collecting and entering data into a computer
Working independently and within a team as needed
Developing and maintaining strong interpersonal relationships
Maintaining excellent attendance
Being adaptable to support business needs, including moving from one manufacturing team or facility to another as needed (this may include some variability in shift hours between buildings)
One year of demonstrated, consistent work experience (full time 36-40 hrs a week)
Demonstrated basic computer and math skills
Good documentation skills
Quick learner
Problem solver
Self-directed and motivated
Task oriented
Safety oriented
Demonstrated ability to
Work independently and within a functional team
Demonstrated ability to be flexible and open to change

Head Device Development, Medical Device Unit Resume Examples & Samples

BS Degree in Science or Engineering
Minimum of 10 years’ experience in medical device development of complex technical products
Minimum of 5 years’ experience in drug-device combination development
Understanding of systems thinking (drug+container+device+software+app = system)
Advanced degree in engineering or life sciences
International business experience
Understanding of electronics and software development
Experience with Regulatory agencies; FDA, EMA
Language capabilities in French and German in addition to English
Primary container development experience
Experience with manufacturing and in particular high volume manufacturing

Medical Device Engineer, / II Resume Examples & Samples

Medical Device Engineer I: Bachelor of Science with five to eight years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Masters of Science with three to six years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Ph.D. with one to three years of experience in the pharmaceutical, biotech, device or drug delivery industry
Medical Device Engineer II: Bachelor of Science with nine to thirteen years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Masters of Science with seven to eleven years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Ph.D. with three to six years of experience in the pharmaceutical, biotech, device or drug delivery industry
B.S. or M.S. degree in Mechanical/Electrical/Biomedical/Material/Chemical Engineering, Pharmaceutical Sciences, or related applicable technical field
Understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry
Knowledge of the drug development process and the importance of the application of device development capability to this process
Basic knowledge and experience of other areas outside of own specialist area such as formulation and analytical development
In-depth knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.)
Experience with the development of devices for biotechnology compounds
Good communication skills and strong interpersonal skills are essential
Demonstrated leadership capabilities, organization, flexibility, and the ability to operate in a fast-paced environment
Ability to demonstrate up to date technical knowledge
Strong work habits and commitment to the position
Problem solving, a hands-on scientific approach, innovation and creativity
Ability to identify critical activities and prioritize tasks

Medical Device Operator Resume Examples & Samples

Setting up equipment and operation
Hand assembly and visual inspection
High school diploma, GED, or equivalent
Demonstrated one year of consistent work experience (full-time 36-40hrs a week)

Medical Device Operator nd Shift Resume Examples & Samples

Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
Working within a team in a controlled/clean-room manufacturing environment with required clean room garments
Performing data collection/computer entry
Following Standard Operating Procedures (SOPs)
Demonstrated good verbal and written English skills

Medical Device Coordinator Resume Examples & Samples

Experience working as a Surgical Tech and/or Cath Lab Tech
OP Acute Care Coding experience
Familiarity with explanted items
Experience working with MS Excel

Category Manager for Consumer & Medical Device Resume Examples & Samples

BA/BS degree
Minimum of 3 years of experience in procurement or sourcing as a user or provider
Demonstrated functional experience or knowledge of at least one of the following is required: Clinical trials, IVRS, project management, laboratory services, GLPs, CMPs, GCPs
Ability to travel 10% domestic and international
BA/BS in Business, Life Sciences or related field

Senior Medical Device Engineer Resume Examples & Samples

May include but not limited to performing one or more processes within quality specifications while visually monitoring the machines/equipment used to ensure proper function
Ability to rotate through the assembly line, performing all production assembly operations
Performs on-line and in-process visual inspection of products to ensure it meets specifications per work order and procedure instructions
Assists Team Leader and Technicians with product and/or machine change-overs
Operates equipment at or above reasonable expectancy levels
Ensures product assembled meets quality standards
Rejects product outside of specifications
Adheres to safety standards
May operate a variety of testing equipment required for periodic product and process testing
Performs other related assembly and processing tasks, as required
Lifting -- Not to exceed 50 lbs. -- local practice may apply
Bending
Visual acuity
Color perception
Reading
Field of vision/peripheral
Fine motor skills
Noise
Chemical vapors
Soldering fumes
Education and/or experience equivalent to a high school diploma or certificate of leaving (Ireland)
Three months of assembly experience required
Previous experience of rotating through and performing all tasks on the assembly line including technical tasks requiring precise motor skills
Ability to visually check work performed and identify whether a product has been assembled correctly
Ability to follow instructions in performing repetitive tasks
Attentiveness in performing tasks
Ability to work as a team member in assembling sterile medical products
Ability to meet line rate expectations

Medical Device Resume Examples & Samples

Bachelor’s degree or equivalent experience
Passionate about data
Highly detail oriented with a critical degree of accuracy regarding data entry and analysis
Demonstrated project management success
Handles multiple conflicting business problems simultaneously under time constraints
Proficiency in MS Office applications
Knowledge of medical device types preferred
Healthcare/Medical device knowledge & Multi-Vendor biomedical service experience preferred
Experience with Salesforce administration a plus

Global Key Account Manager Medical Device Resume Examples & Samples

Foster business growth with existing clients and develop new opportunities in the Clinical Trials business with new customers
Co-ordinate and prepare customer proposals and budgets for new and existing business opportunities
Assess business impact of contracting opportunities to include overall profitability and impact on sales and margin
Supervise all customer orders are executed on time minimizing delays to customer
Liaise with the appropriate internal departments to ensure operations are running with no delays
Anticipate changes in the market environment and provide appropriate strategic recommendations maximizing our commercial objectives
Support the Global Clinical Trials Manager to implement the core business processes of SOP, NPI, to ensure Clinical Trials commercial delivery
Develop and streamline the commercial business processes with an aim to simplify processes whilst maintaining effectiveness
Bachelor's degree in Business or Life Science
Min 3 years of work experience required
Previous experience in strategic consultancy or in commercial function with pharmaceutical & medical device products. Experience in the Clinical Trials Market would be a plus
Self-starter who is target driven, thrives on success, ability to be autonomous and self-motivated
Critical for success: demonstrated analytical capabilities and problems solving skills, negotiation skills, and contract/legal experience, excellent oral and written communication skills
Innovative thinking: ability to identify improvement opportunities, challenge status quo and drive changes as required
Incumbent will demonstrate the necessary, self-motivation, attitude, confidence and leadership to work collaboratively with other commercial channels, across functions, with other divisions, functional peers such as Marketing, Contract Marketing, Credit/Finance and Account Sales & Services to deliver business results and solutions
Fluent in English, other languages are a plus

Medical Device Electronics Process Leader Resume Examples & Samples

Ensure the functioning and optimization of the production activities, to meet customer expectations
Investigates Customer Complaints as assigned
Conducts all phases of CAPA investigations as assigned
Creates document change packages resulting from the action phase of CAPA investigations
Works with the engineering team on product testing and design transfer activities of new electrical products
Works with the engineering team on product improvements
Assembly and testing of devices
Selection and procurement of alternate components for devices
Service and CAPA activities
Oversees service department, including the following responsibilities
B.S. or Engineering degree (EE preferred)
5 to 8 years Electronic Medical Device manufacturing/service
Knowledge of GMP and ISO regulations
Troubleshooting skills in embedded systems, including the ability to read and follow electrical schematics
Basic knowledge of radiofrequency systems, function generator equipment and low voltage applications

Senior Specialist Medical Device & Combination Products Resume Examples & Samples

System Steward
Manage activities related to electronic quality systems, e.g. document and record systems, Trackwise Change Control and Trackwise Corrective and Preventive Action (CAPA), Success Factors training, etc
Assist with system configuration and maintenance
Maintain document and record integrity in electronic systems
Prepare for CAPA and change control meetings and manage meeting records and documents
Collect, graph and analyze data for quality metrics
Manage MDCP projects for Quality System Improvement Program (QSIP) activities
Document Steward
Write standard operating procedures and create forms and templates
Manage documents in the electronic systems through their life cycle
Create training materials for documents
Manage MDCP records
Training Steward
Create and manage training curricula for each MDCP job function
Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others. Effective written and oral communicator. Able to speak up and contribute in a team forum. Able to apply prior experiences and learning’s in new settings, even if these are unfamiliar
Proven working experience in project management
Proven experience with electronic quality systems, e.g. document management, training, CAPA, change management
Proven experience authoring documents
Excellent client-facing and internal communication skills
Excellent written and verbal communication skills with experience presenting information at meetings
Solid organizational skills including attention to detail and multi-tasking skills
Strong working knowledge of Microsoft Office suite of software
Working knowledge of technical aspects of device development and commercialization. Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset
Development and delivery of training is an asset

NTO QMS Medical Device Expert Resume Examples & Samples

Lead and participate in the harmonization and continuous improvement of the processes and Quality Management System across the different groups in Global Drug Development and Novartis Technical Operations. Oversee the implementation of the harmonized Quality Management System, ensure the continued effectiveness of the Quality Management System driving and/or coordinating mitigation(s) as appropriate
Lead projects associated with implementation of new standards and regulations. Assess, define and track actions to ensure that the Quality Management System is up-to-date to the relevant regulatory requirements. Keep up to date with new regulations in development, review and enforcement. Represent Novartis Technical Operations Quality Management System in the consultation processes for such new regulations
Oversee the implementation of the mid- and long-term strategies for the Quality Management System certification for medical devices. Support the appointed Management Representative in the corresponding interactions with Notified Bodies or other Competent Authorities
Ensure alignment of processes with Quality Management System relevant for medical devices. Act as Quality System Owner and author for selected Quality Management System and Global Operating Procedure. Review Quality Management System and Global Operating Procedure, provide review/comments and consolidation as medical device Subject Matter Expert
Report the status of the Quality Management System , provide review/comments and consolidation as medical device Subject Matter Expert
Report the status of the Quality Management System periodic management review meetings
Drive the preparedness activities for global medical device Quality Management System Audits and Inspections of "Notified bodies", authority inspections and internal / external audits and other regulatory bodies e.g. Food & Drug Administration. Coordinate the audit team during inspections. Support local groups when required for local medical device inspections. Coordinate and/or participate in follow up of Audits and Inspections
Manage Quality Events, monitor the progress of globally defined corrective and preventive actions to ensure the issues are adequately addressed, completed and appropriately documented
Works closely with IT Quality Assurance system project leaders to prioritize changes in Quality Management System and Global Operating Procedure together with the IT systems harmonization
Acting as back up for Compliance activities: Audit and inspection support on preparation, inspection, follow up and closure. Acting as Follow Up Responsible Person (FURP)
Lead and support selected global Device initiatives and projects and medical device networks
Participates at the Global Quality Management System Council, Quality Management System Governance Board and others as required
Responsible to follow up the Annual GXP training plans. Contribute to the development and execution of medical device trainings

Medical Device Closure Specialist Resume Examples & Samples

Product development and product engineering responsibilities for sterile Barrier Closure Systems
Technical contributor for CMR and NPI projects
Active member of 3M technical community that leverages Device Closure technology development across the company
Monitor competitive and industry trends to identify new opportunities for business success
Bachelor's degree or higher in a science or engineering discipline from an accredited institution
Minimum of one (1) year (academic and/or industry) medical device environment experience
Minimum of three (3) years Research & Development experience
Master's degree or higher in Chemical Engineering, Chemistry or Materials Science from an accredited institution
Experience in selection and development of device closure systems which may provide a sterile barrier for the product
Experience and knowledge in sterilization methods and how various methods affect both packaging and product
Proven ability to interact effectively within a pilot plant or manufacturing environment
Excellent verbal and written communication ability
Creative, self-driven individual with a track record of success
Detail-oriented with excellent organization skills
Passion for the medical device industry

Medical Device Regional Manager Resume Examples & Samples

Management and development of reporting staff. mentor others as appropriate
Background of success in value-based solution-selling
Ability to influence and lead both with and without direct authority
Executive-level business and financial acumen with strong negotiation skills
Ability to confidently speak in public, often for high-level executives
Ability to form and develop long-term strategic, interpersonal, professional senior-level relationships. display socially and professionally appropriate behavior
Ability to work independently, in groups and to effectively lead groups
Demonstrated leadership skills, initiative, critical-thinking and problem-solving skills
Strong organization, time- and project management skills
50% travel

Medical Device Resume Examples & Samples

Design, plan and implementation of test cases, requirement based verification. Test script and test harness development and maintenance
Reporting to various project stakeholders
Build and maintain test automation via QTP
Provide testing expertise, including building up and maintaining test scripts and test harness
Create and execute test cases based on the system requirements specifications to ensure proper operation
Testing and verification of components, including module test and target test of new features as well as regression target test for release
Demonstrate Danaher values and adopt DBS tools across team

Medical Device Resume Examples & Samples

Responsible for designing and implementing state of the art software solutions with ability to own and drive a task, desire to act as a lead on a task force
Defines Product, System, Components objectives by analysing user requirements; envisioning system features and functionality
Participate effectively in estimation, planning, cost-of-quality, and quality risk analysis is desired
Completes applications development by coordinating requirements, schedules, and activities; contributing to team meetings; troubleshooting development and production problems across multiple environments and operating platforms

Medical Device Resume Examples & Samples

Responsible for architecting and designing features implementation approach for state of the art and complex software solutions within medical devices domain with ability to own and drive a task, desire to act as a lead on a task force
Participate in a design phase of new features and drive the flow from requirements to implementation with quality in mind. Defines Product, System, Components objectives by analysing user requirements; envisioning system features and functionality
8-12 years of software development experience where of 5+ years in architecting .Net (C#) applications, Microsoft Certified Professional will be highly desirable
Must have experience and domain knowledge within the medical devices development industry
Strong skills in .Net C#, WPF, Design and Architecture patterns such as MVVM, MVC, MVP, Windows desktop application development experience
Optional experience with UX as part of the development process would be added advantage but not essential
Ability to act as a technical driver for the rest of the team. Solid verbal and written communication skills
Hands-on experience with MS tools and technologies such as Visual Studio, Nunit unit testing and mocking framework
Possess strong analytical skills, with excellent problem solving abilities

Medical Device Resume Examples & Samples

Motivate and empower the team, ensuring high performance and on Time Delivery of various projects
Ensure transparent communication with stakeholders from Radiometer outside of India
Ensuring full compliance with relevant work practices, as required by authorities for medical device product development and Radiometer quality system
General Software projects management, organize the status meetings and communicate the Status Report
Management reporting and ensure the timely delivery of different testing milestones, daily management of the software teams (scrum master)
Responsible for development and test operations – design, plan and execute
Understand the development and testing effort by analysing the requirements of the project. Estimate and obtain management support for the time, resources and budget required to perform the activities
14+ years of professional work experience in software development projects and Managed teams for delivery
Working with medical devices and minimum 2 years of documented experience of leading teams and individuals
Must have experience and domain knowledge within the medical devices development industry and experience of working in agile development methodologies with understanding of several aspects of SW development processes
Must have experience with managing diverse teams of SW professionals, recruiting talent, developing people for optimal performance
Proven ability to create a high performance culture which fosters On-Time-Delivery with Quality and Content
Knowledge of C# (.Net Application), WPF, DB
Solid verbal and written communication skills and able to take decisions even under pressure
Able to think analytically and to draw conclusions, possess strong analytical skills, with excellent problem solving abilities
Organized and persistent: Able to prioritize, organize and get things done. Good at executing
Ambitious, performance oriented and able to work independently
Operational mind-set with focus on deadlines, detail and quality oriented
Flexible, willing to “go the extra mile” while at the same time being an agile and fast learner

Associate Medical Device Specialist, Vascular Resume Examples & Samples

Responsible for exhibiting competencies with the Teleflex Vascular product line
Responsible for exhibiting understanding of Teleflex Vascular Competition
Responsible for completing and sending in expense reports with the appropriate documentation in accordance with company policy
Responsible for assisting Marketing Department on surveys and gathering customer and competitive information
Responsible for assisting in National and local trade shows, cadaver labs and training programs when requested
Responsible for participating in quarterly and national sales meetings
Responsible for consistently updating customer database through SF.com and communicate those updates to Sales and Marketing counterparts
Responsible for filling out customer complaint forms on a timely basis and sending to Quality Assurance
Responsible for sharing competitive information with home office staff, their RSM counter-part and Area Manager
Responsible for consistently prospecting for new customers
Responsible for taking proper care of Teleflex products in their possession
Responsible for prudently managing their company expense account
Responsible for making sales presentations in accordance with the Teleflex Code of Conduct
Responsible for participating in designated conference calls
Responsible for following up on requests made by Regional Sales Managers/Area Director
Responsible for assisting in, creating and initiating strategies and tactics to increase utilization in the RSM’s sales territory
Bachelor’s degree (BA/BS) from a four-year college or university
Proven track record of success in sales
Able to spend a significant amount of time (60 - 70%) traveling in the U.S
Advanced level proficiency with computer skills (MS Office, Word, Excel and PowerPoint)
Outgoing with a positive attitude
Possess a valid driver’s license and operate a motor vehicle with satisfactory driving records
Carry detail bag weighing up to 20 lbs
Lift equipment weighing up to 30 lbs
Be standing or walking in numerous hospitals or at meetings for 6 – 10 hours per day, up to five (5) days per week
Interact with others through effective, verbal communication

Medical Device Package Manager Resume Examples & Samples

Regular attendance and punctuality
Develop/improve processes in the Package Testing Lab
Guide clients to appropriate testing requirements
Provide Medical Device packaging expertise to internal/external customers
Sample preparation, physical testing, and generation of test reports
Conduct testing in accordance with written SOPs and industry standards, following Good Laboratory Practices (GLPs) and/or Good Manufacturing Practices (cGMPs)
Responsibly manage data in Laboratory Information Management Systems (LIMS) and Laboratory Notebooks
Develop technical reports of test results following defined documentation procedures
Ensure proper maintenance and operation of test equipment
Assist in equipment qualification and development of SOPs
Assist in receipt/storage of customer samples
Demonstrate and maintain awareness of technical innovations and progress in package testing
Share in maintaining tidiness of laboratory
An understanding of mechanical testing techniques for medical device packaging, including testing standards in ASTM D4169 and ISO guidelines
Will have a hands-on approach to setting up testing equipment, with the ability to teach and coach subordinate technicians
Effective writing skills for production of technical reports, standard operating procedures, and would be able to compile data for client reporting
Advanced understanding of the Medical Device industry or package design industry. A candidate may not have direct experience in medical devices packaging, experience with package design and testing protocol would be considered
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Bachelor's degree in engineering or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
Ten years Medical Device Packaging experience, or related package design testing experience

Medical Device Reprocessing Coord Resume Examples & Samples

Overseeing or taking an educational role in device preparation (pre-cleaning and decontamination) in readying product shipment to Medline ReNewal. Making recommendations and improvements as necessary
Identifying products that are able to be reprocessed and then offering suggestions to key personnel regarding savings opportunities
Taking part in In-Service sessions as directed by Account Manager or Regional Sales Director
Conducting 1-on-1 and small group feedback discussions and use of survey tools to gather information
Must live in the general area of Oklahoma City, OK
Must have valid driver's license, clean driving record, and dependable vehicle with insurance to use in travelling between multiple hospitals
Demonstrated customer care and support skills with an emphasis on responsive, proactive support

Medical Device Development Engineer Resume Examples & Samples

Requires Bachelor’s degree in ME, EE, IE, OE, BME, or other relevant field with 8+ years of experience in the design, development and manufacturing of a product (device, part, component, etc.), preferably in the medical device industry
Prepare and implement small single discipline project or subprojects of an integral project, in accordance with agreed conditions on specification, time, cost and staffing
Responsible for execution, progress, and quality of the project. Small project, mainly reuse (of in-product HW,SW,E in case of a technical project)
Planning, leading, and tracking Leads a small team of approximately 5 team members
Microscope experience
Previous experience in a Controlled Environment Area

Medical Device Reports Specialist Resume Examples & Samples

Ensure complaint investigations are adequate, accurate, detailed and timely
Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint
Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility
Complete electronic submission of MDRs to the FDA
Ensure accurate data entry, scanning, and retention of documents to complete event files
Complete projects as assigned and required specific to post-market quality and complaint handling
Knowledge of CRHF products and therapies
Experience with complaint handling, MDR/Vigilance reporting
Solid knowledge of word processing, spreadsheet, database and presentation applications

Senior Medical Device Engineer Resume Examples & Samples

Assuming full accountability for the management of individual cases (Inquiries & Complaints) in our Blood Gas and Electrolytes System business according to regulatory and ISO Quality system requirements and needs of the Country Organizations In a timely manner
Collecting all relevant data and evaluating each escalated complaint to determine if investigation is needed
Resolving cases and preforming correct processing and documentation for individual cases according to applied medical standards and quality system
Communicating evaluation/investigation results to Affiliates and other global interfaces
Collaborating with investigation teams to ensure an efficient approach for root cause analysis and with Business Area and global functions, and ensure appropriate measures from cases are derived

Medical Device Leadership Development Program Resume Examples & Samples

Complete 9 month comprehensive rotational program in various departments and gain insight and understanding of different functional roles and departments that support the Field Sales Organization
Develop and implement a proactive plan that involves clinical and service support, with Region Managers and team members, to maintain market share and increase the quality of service to customers
Advance our mission of transforming lives through innovative medical solutions that improve the health of patients around the world
Conduct excellent product in-servicing, product evaluations, and continuing education programs
Assist in the BSC sponsored professional education activities by participating in on-site and field training workshops
Provide timely updates to multiple managers including business activities, competitive conditions, industry trends, etc
Prepare comprehensive plans, by account, which reflects overall Endoscopy Division strategy
Maintain accurate records of sales expenses, customer files and field sales reports required
Conduct all sales activities according to Travel & Entertainment (T&E) guidelines, Industry and Integrity Policies
Undergraduate degree in Business / Engineering, or other technical / relevant coursework
Strong record of academic achievement and leadership experiences
Demonstrate analytical, technical, communication and problem solving skills
Able to build and maintain strong customer relationships
Must be energetic, enthusiastic, determined and goal oriented
Willingness to relocate within in the US and open to significant regional travel (up to 70%)

Senior Medical Device Resume Examples & Samples

Provide practical legal counselling and commercial contracting support for the applicable businesses R&D, clinical research, procurement, manufacturing, logistics, marketing, sales, and service activities
Coordinate and facilitate other related business initiatives when applicable; and
Develop and deliver internal training materials to your clients with respect to compliance and legal matters related to all of the above
Providing successful legal commercial/transactional support for the development, purchase and sale of medical devices and services; software maintenance and support; clinical research trials - both sponsored and investigator initiated studies; procurement and other consulting services
Litigation management
Applying health care Compliance laws (i.e. among others Medicare Fraud and Abuse, Discount and Personal Services Safe Harbors, and Sunshine Law)
Applying FDA regulatory guidance as part of a team to commercial and clinical research activities
Identifying business and legal risks and offering creative solutions and counseling based on a reasonable balance of the applicable issues and risks; and
Providing clear ethical guidance in all aspects of work
Counselling on the proper use of health care and other personal data for R&D, marketing, and other commercial uses, under HIPAA and other applicable law
Managing product liability litigation matters with outside counsel, advising on marketing claims development for direct to business and consumer advertising, advising on marketing and sales programs from a compliance perspective; and
Prior experience negotiating clinical trial agreements with hospitals and research institutions is a plus
J.D. from an accredited U.S. law school and admission to a state bar
A collegial, cooperative and an open person who enjoys being a team player and builder in a rapidly changing environment, and feels comfortable working in a global environment on projects involving professionals from around the world
Persuasive presentation and counseling skills
Excellent contract drafting skills
Strategic thinker
A keen interest in all types of technology
A passion about improving how health care is delivered

Medical Device Collection Tech Resume Examples & Samples

Coordinate the packing of devices in Medline ReNewal shipping containers (employing proper techniques to ensure safe shipment of product)
Update the Medline ReNewal Collection Container Locations sheet to provide an accurate record of where all containers have been placed throughout the facility
Provide support to in-service sessions as directed by the assigned Account Manager
Make regular rounds throughout the facility; initially to introduce self and Medline ReNewal, and eventually to help answer questions and share any staff concerns with the assigned Account Manager
High School Diploma (GED) preferred
Residence in the Bryan, TX area or employment at CHI St. Joseph Hospital preferred
Ability to regularly lift at least 30 pounds as a regular part of daily tasks
Ability to begin work at an early hour (i.e. 6AM) to align with the schedules of facility staff members
Able to be credentialed at the highest level in order to gain admittance to all required rooms within each designated facility

Medical Device Collection Technician Resume Examples & Samples

Establish and follow a regular schedule to visit the assigned facility in order to collect devices in the designated containers
Arrange for shipment of collection containers in a timely manner
Ensure program supplies remain stocked for use; distribute program collateral throughout the facility as directed by the assigned Account Manager
Residence in the Syracuse, NY region
A current valid driver’s license, vehicle insurance, clean driving record and ability to travel in own vehicle to designated facility
Good communication skills; especially on a verbal level
Strong organizational skills and attention to detail to complete work tasks in a thorough manner
Self-initiative and dependability to reliably perform the job in an independent setting

Medical Device Engineer Resume Examples & Samples

Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects
Document development work including writing specifications for manufacturing or scientific test results
Ability to solve routine design and engineering tasks with some assistance. Able to solve problems with periodic monitoring
Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects
Ability to discuss normally encountered technical or project management issues, both verbally and in written form
Ability to work as a collaborative team member
Ability to solve routine design, engineering problems with assistance
B.S. and 3 - 5 year related experience (in-house, co-op or acquired outside)

Medical Device Reprocessing Coordinator Resume Examples & Samples

Making regular rounds throughout the facility to address questions / concerns and assist in device flow processes
Educating and training staff on the value of reprocessing and reprocessing best practices
Must be able to receive and maintain hospital certification (multiple vaccinations required) to access assigned facilities
Demonstrated aptitude to build relationships, obtain buy-in from key personnel and successfully “market” self as a value-add resource, as well as Medline ReNewal as a trusted partner

Development Engineer Medical Device Resume Examples & Samples

Provide project and technical leadership on cross-functional team for devices through preclinical development, product registration and commercialization
Lead all project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. Responsible for clear, concise, well written design history documentation, EU technical files, and manufacturing specifications
Establish maintain detailed project plans define risk and recommend contingency plans
Lead the creation of design control elements to comply with medical device regulations to support the development of products in accordance Product Development Process and Design Control requirements as well as compliance with Good Manufacturing Practices (Quality Systems Regulations), Standard Operating Procedures, and Safety requirements
Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers
BS degree in Engineering required Master’s degree preferred
6 + years medical device experience coupled with development and commercialization success
Strong hands on experience in injectable biomaterials based device design/development ideal
Technical leadership experience with biomaterials delivery system development and scale-up
Leading projects with external design, development and manufacturing partners
Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO13485 requirements, DFSS certification is desirable
Strong communication skills (written and verbal), including experience presenting in front of cross-functional audiences
Must be able to multitask, handling a variety of projects simultaneously

Risk Manager, Medical Device Resume Examples & Samples

Demonstrable experience of Risk Management and Design Controls (preferably in the area of user-focussed Risk Management) in Medical Device or Pharmaceutical Industry
Strategic thinking in the inter-relationship between user-focussed risk management and device design and development
Experienced in ISO and FDA regulations and standards as applicable to device design and risk management
Appropriate Science or Engineering Degree
Excellent verbal and written communicator; clear and concise in communications with internal and external partners

Medical Device Operator Resume Examples & Samples

Working in a cleanroom manufacturing environment manufacturing implantable medical devices
Setting up equipment and operating in a multitask environment
Performing data collection/entry within manufacturing data collection systems
Following Standard Operating Procedures (SOP's)
Performing all manufacturing operations as required to support business needs (This may include some variability in shift hours.)
Demonstrated one year of consistent work experience (full-time 36 - 40hrs/week)
Previous experience with manufacturing equipment and tools

Medical Device Technician Resume Examples & Samples

Will perform PM's and repairs on a variety of biomedical equipment
Will mentor and assist PM technicians as required
Will identify training needs for self
Will assure the service area is clean and orderly, providing a safe environment for service personnel
Will assure accurate database entry and reports
Expected to meet production goals set for department
Will participate in department on call rotation
Some knowledge of various hospital / homecare medical equipment
Excellent customer communication skills
Computer literate with an understanding of database operations
Understanding of and ability to operate basic electronic test equipment
Basic knowledge of electronics, electricity, electro-mechanical, fluidics, pneumatics and hydraulic theories and practices
Associate's Degree in an electronic field, preferably biomedical, or a combination of education and experience
Strong attention to detail, ability to maintain focus with intermittent distractions
Ability to communicate with all levels of personnel

Temp to Hire Medical Device Assemblers Resume Examples & Samples

This position requires demonstrated communication skills and the ability to withstand repetitive motion
High school diploma or GED or equivalent
Must be able to demonstrate conversational English
Must be able to demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities
Must have the ability to lift up to 50 lbs
Have good hand/eye coordination and ability to handle and manufacture small and delicate parts
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive
Completes during the manufacturing process: cuffing, gluing, assembly, hand marking catheters, and running leak, packaging, prep, removing flash, cleaning components, setting pins, lead testing and pull testing
Follows safety guidelines; GMP and Hazmat
Follows applicable Standard Operating Practice and drawings
Checks to verify procedures and revisions
Monitors processes for rejects or deviations from quality standards
Perform rework and scrap
May be called upon to complete other tasks as needed and assigned by the Supervisor
*Please do not contact the local Kelly Services branch as they are not recruiting for this position. For immediate consideration, please reply directly to this posting or email your resume to shac759@kellyservices.com ***

Associate Medical Device Specialist Resume Examples & Samples

Account maintenance visits
Account inventory checks
Assist with account in-servicing upon sales close of new business
Thorough understanding of BIS product offerings through in-house product training and account procedure observations
Clinical support staff interviews to obtain information relative to products, competition and challenges
Assist with product evaluations as needed
Assist MDS where needed so that he is able to pursue new business opportunities
Knowledge of hospital structure, BIS products and prior sales experience is desired but not required
Ability to work a very large territory with overnight travel
Follow through on projects and tasks with direction from MDS, Bill Corbin
Ability to work well independently and within a team environment
Interact with a diverse group of people at all levels
Portray a professional image
Ability to follow direction well
Understand products and services thoroughly in an apprentice role
Business travel is at least 70% of the job
Driver’s license required
Residence in major metropolitan area within territory

Global Quality Coordinator, Medical Device Resume Examples & Samples

Develop and implement an effective Global Post Market Surveillance program within Bauer, including analysis, trending, reporting of product issues to regulatory agencies and the resolution of product complaints
Act as principal contact for 3rd party audits and regulatory inspections of Bauer medical device operations, including planning, preparation, execution, reporting results, and follow-up
Ensure the effective development and maintenance of the Bauer medical device design and development files and risk management files, including Hazards Analysis, Use FMEA, Design FMEA and Process FMEA
Partner with Bauer vendors to develop business relationships and ensure their compliance to GMP, and where necessary, their conformance with the requirements of ISO 13485, to facilitate the completion of Supplier Corrective Actions
Stay current with global regulatory requirements
Conduct training of internal and external stakeholders
Perform other duties and responsibilities as needed

Medical Device Resume Examples & Samples

Ability to clearly, concisely and accurately convey communications
Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior
Ability to work independently and as a team member
Demonstrated initiative and problem-solving skills; analytical and critical-thinking skills
Ability and aptitude to use various types of databases and other computer software
Ability and aptitude to provide solutions and contingency plans through the comprehensive review of alternatives
Ability to present material to Executive-level management

Medical Device Operator Resume Examples & Samples

Be passionate about providing manufacturing state-of-the art medical devices
Standard Weekly Hours: Monday - Thursday 3:15 p.m. - 12:15 a.m., Friday 10:00 a.m. - 2:00 p.m. OR Monday - Friday 3:15 p.m. - 11:15 p.m. (8 hour days)
Demonstrated small parts assembly
Work in a cleanroom environment and wear cleanroom garments
Able to work with small parts, with good hand/eye coordination
Must have ability to work independently and function effectively as a member of a large team
Must be extremely detail-oriented and organized
Must possess basic computer and math skills
Must be self-directed and motivated
Must have effective communication skills, both verbal and written
Ability to make detailed and accurate observations
Demonstrated ability to positively influence teammates
Flexibility to adapt and change to meet manufacturing need
Work the scheduled shift and overtime as needed by the business
Basic computer skills with the ability to learn more advanced systems

Medical Device Installation Technician Resume Examples & Samples

Under supervision, evaluate and implement setup and preparation of medical equipment
Associate’s or Bachelor’s degree in Electrical Engineering, Biomedical Engineering,Mechanical Engineering, or related field; OR equivalent military education; OR participant in the formal GEHC Biomed/FE Services Internship or Military Externship program; OR High School Diploma/GED and 2+ years of experience servicing electrical, electronics, IT or mechanical equipment
Analytical and communication skills with the ability to communicate technical issues to the customer in an easy to understand manner
Candidate must be able to lift, carry, push, and pull up to 35 lbs. unassisted and frequently bend, stoop, twist, climb, crouch/squat, kneel/crawl, sit and stand for long periods of time
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, please use the “SUBMIT RESUME” button below to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position (beth.stumbaugh@kellyservices.com). Your resume must be received via the “SUBMIT RESUME” button included within**

Medical Device Reprocessing Pgm Coord Resume Examples & Samples

Assisting in the OnDemand training process and setting up designated system users for Auto Notifications
Observing cases and monitoring case flow to ensure optimum reprocessing steps are taking place (or to identify areas of improvement)
HS Diploma required
Must live in the general area of Wausau, WI
Strong interpersonal and communication skills (oral and written); must be fluent in English
Strong organizational and time-management skills; ability to apply structure and self-discipline within day-to-day work regimen to achieve goals

Territory Manager Joints Medical Device UAE Resume Examples & Samples

Identify achievable and relevant quarterly target customers in all segments that lead to meeting annual Business Plans
Accomplish quarterly, monthly and weekly priority sales goals through efficient use of time and resources
Routinely follow the sales process in order to consistently advance target customers along the selling cycle
Continuously expand knowledge necessary to represent our complete product line to all customer segments in a professional manner
Routinely ensure customer satisfaction with all products by providing education in proper product application, features functions and benefits
Manage business relationships and external/internal customer communications in a cooperative, timely and efficient manner
Scrubbing with surgeons inside OR
Good knowledge of Arthroplasty orthopedic business in medical device sector
LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce Our Credo
CONNECT: Develop deep insights into the needs of our patients, customers, markets and communities
LEAD: Create an environment where leadership and talent development is top priority
DELIVER: Deliver results by inspiring and mobilizing people and teams.1700178273W

Medical Device Resume Examples & Samples

Monitor and manage efforts of cross-functional project teams
Define project workloads and assignments
Mentor project managers and support staff
Meet with team members on a regular basis regarding project tasks to ensure project milestones are met
Collect information on team performance against contract, customer expectations, and project baselines
Lead problem solving and resolution efforts
Develop and maintain internal databases and project plans
Supervise maintenance of project management information and tracking systems
Manage project budgets
Produce and distribute reports and presentation materials
Provide input to line managers of project team members' performance relative to project tasks
Participate fully in proposal development, participate in bid defense presentations in partnership with Sales and senior Project Management staff; provide input on scope and budget development
Implement continuous improvement activities for assigned projects
May have supervisory responsibilities for project support staff

Medical Device Associate Resume Examples & Samples

2012-2016 JD: Top schools/grades required
Experience counseling device and diagnostics companies ranging from start-up ventures to multinational manufacturers, clinical laboratories, and industry trade associations
Additional work experience advising clients on post-market compliance issues, adverse event reporting, field action, and advertising and promotion requirements and also preparing materials for pre-market clearance and approval of new medical devices preferred

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