Medical Devices Resume Samples
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Medical Devices Resume Samples
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FR
F Rolfson
Felton
Rolfson
98676 Ankunding Well
New York
NY
+1 (555) 978 0233
98676 Ankunding Well
New York
NY
Phone
p
+1 (555) 978 0233
Experience
Experience
Dallas, TX
Complaint Analyst / Medical Devices Vigilance
Dallas, TX
Walsh-Wiegand
Dallas, TX
Complaint Analyst / Medical Devices Vigilance
- Issues closing letters to affiliates when product analysis has been performed
- Participate on project teams to improve department processes
- Responsible for communicating business related issues or opportunities to next management level
- Maintains knowledge of Biosense Webster products and their use
- Educates field sales force and affiliates in utilization of complaints department for reporting of field complaints
- Documents all information according to Biosense Webster policy and EMEA regulatory standards
- Responsible for ensuring personal and company compliance with all local and company regulations, policies and procedures
Houston, TX
Medical Devices Technical Specialist
Houston, TX
Boehm and Sons
Houston, TX
Medical Devices Technical Specialist
- Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge
- Provide “Technical Sales/Networking” support to the commercial team and promote BSI
- Deliver technical reviews and certification scheme management in support of CE marking
- Participate in client meetings to facilitate CE marking processes
- Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel
- A team player good at relationship building internally and externally
- Provide in-house and external training for orthopaedic & non active dental medical devices
present
Philadelphia, PA
Global Product Manager Medical Devices Regulation
Philadelphia, PA
Hamill, Parisian and Abbott
present
Philadelphia, PA
Global Product Manager Medical Devices Regulation
present
- In conjunction with Global Marketing and Business Manager, develop and support the relevant specific marketing to support business growth
- Develop and evolve the relevant marketing package and tools in collaboration with the Global Operational Marketing Team
- Support the sales, marketing, business development and account activities including sales visits, events/seminars,
- To monitor market trends and track competitors' products to help improving the efficiency of the global business growth strategy
- Actively participate in relevant scheme owner committees or working groups to ensure SGS maintains influence and exposure in the area
- Develop an intimate knowledge of the competition by constantly overseeing competitive activities
- To have overall responsibility for the successful management of the MDR ensuring the global operation is efficient and meets the expectations of internal customers (affiliates), external clients, scheme owners and accreditation bodies
Education
Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
Towson University
Bachelor’s Degree in Engineering
Skills
Skills
- Good computer skills with knowledge of Microsoft Office
- Strong verbal and written communication skills, including the ability to make effective and persuasive presentations
- Demonstrated ability to work effectively in a highly charged, fluid environment
- Very detail-oriented, well-organized, and driven to meet deadlines and program goals
- "Combination" Medical Device/Pharma/Disposables Products
- A self-starter with the ability to work as a Project Leader managing projects and allocation of resources to those projects
- Demonstrated ability to independently manage multiple projects
- Disposable Medical Devices
- Demonstrated working knowledge of scientific principles
- 6 – 8 years’ related experience
15 Medical Devices resume templates
Read our complete resume writing guides
1
Finance Business Partner, Sea-medical Devices Resume Examples & Samples
- A degree in Accountancy/Finance and an Accounting Qualification
- At least 10 years of working experience in an MNC and in the FMCG/Medical industry
- At least 5 years experience in a managerial role
- Experience in a Big 4 Auditing firm will be an advantage
- Excellent communication skills & business acumen
2
Head of Medical Devices, Clinical Development Resume Examples & Samples
- Provide strategic business perspective to leadership of Development Program team(s) and the evolving program strategy; matrix management of Development Program team
- Engagement and communication across franchises and functional lines, including impact on strategic thinking at the Franchise Team and Research and Development Team
- Partnership with Program Management (PM) representative on Development Project team to ensure consistent high quality output from the team, and engagement with PM with regard to exploring opportunities to enhance speed and/or project value
- Close collaboration with the GDTL for the MPS and MLD programs
- Overall development Strategy and Plan
- Accurate and effective budget management for Development Program(s), addressing issues as they arise
- Assessment of Business Development opportunities which could impact on Development Program(s), monitoring external scientific information and competitor activity related to Development Program(s) and modifying project strategy as appropriate
- Tracking progress against program goals and composing monthly reports for senior HGT management and HGT/Shire Leadership teams outlining key strategic events for program(s). These documents contain program milestones, strategic imperatives, and financial information regarding programs
- Responsibilities may include specific post-marketing commitments and lifecycle management opportunities
- 25% Leadership and matrix management of all aspects of the Program Team activities, providing a strategic business perspective developing project strategy and modifying project strategy in response to changing business needs. Provide input into performance assessment of program team members. Ensuring program(s) are effectively represented in key meetings with external stakeholders (e.g. regulatory authorities, Regulatory advisory committees, Payor meetings)
- 20% Communication and engagement with key stakeholders to ensure transparency on program status and alignment on project plans (20%)
- 15% Overall development strategy and plans
- 10% Coordination of budget for Development Program(s), addressing issues as they arise
- 15% Assessment of Business Development opportunities which could impact on Development Program(s), monitoring external scientific information and competitor activity related to Development Program(s) and modifying program strategy as appropriate. Provide a key link to external Key Opinion Leaders in area(s) of focus
- 15% Responsible for tracking progress against goals and composing monthly reports for senior line management and HGT/Shire Leadership team outlining key strategic events for program(s). These documents contain program milestones, strategic imperatives, and financial information regarding program(s)
- M.D. with experience managing a Clinical Development program in pharmaceutical or biotech company strongly preferred; will consider Ph.D. with extensive relevant experience, depending on program needs
- >8 years experience in the biotechnology industry with an emphasis on medical devices and/or IVD’s
- Experience of drug development in rare diseases, neurology or neurosurgery would be preferred
- Strong knowledge and understanding of the current technical and regulatory standards for demonstrating safe and effective use of a device and IVD in US and Europe
- Experience of team leadership in a matrix management environment preferred
- Experience interacting with CDRH and with taking devices to market and presenting data to regulatory agencies/Advisory Committees preferred
- Experience in modifying program plans and defining creative solutions to meet business needs
- Experience in managing vendors and external partners
3
Head of Medical Devices, Clinical Development Resume Examples & Samples
- 25%: Leadership and matrix management of all aspects of the Program Team activities, providing a strategic business perspective developing project strategy and modifying project strategy in response to changing business needs. Provide input into performance assessment of program team members. Ensuring program(s) are effectively represented in key meetings with external stakeholders (e.g. regulatory authorities, Regulatory advisory committees, Payor meetings)
- 20%: Communication and engagement with key stakeholders to ensure transparency on program status and alignment on project plans (20%)
- 15%: Overall development strategy and plans
- 10%: Coordination of budget for Development Program(s), addressing issues as they arise
- 15%: Assessment of Business Development opportunities which could impact on Development Program(s), monitoring external scientific information and competitor activity related to Development Program(s) and modifying program strategy as appropriate. Provide a key link to external Key Opinion Leaders in area(s) of focus
- 15%: Responsible for tracking progress against goals and composing monthly reports for senior line management and HGT/Shire Leadership team outlining key strategic events for program(s). These documents contain program milestones, strategic imperatives, and financial information regarding program(s)
- >8 years experience with Human Factors Analysis, medical devices and/or IVDs within the biotechnology industry or medical practice
4
Financial Controller, Medical Devices Resume Examples & Samples
- Drive strategy and support growth in the APAC region
- Review of monthly management accounts and KPI reports as they relate to APAC entities, identify and resolve issues and capitalise in opportunities
- To hold budget review meetings and provide challenge to APAC Department Heads of their budget for the coming financial year
- Work closely with tax and treasury team
5
Medical Devices Associate Resume Examples & Samples
- Direct involvement in company and industry research produced by the team
- Financial modeling to forecast company results and value equity securities, collecting and evaluating industry data, maintaining industry databases
- Translating quantitative financial conclusions into written form, charts and graphs that can be included in research reports and distributed to clients of the firm
- In addition, Research Associates should be flexible in switching between periods of heavy financial modeling and assignments that involve more qualitative writing and presentation skills
6
Business Controller Medical Devices Belgium Resume Examples & Samples
- University degree in Finance/Economics with at least 5 - 8 years relevant business experience
- Expert level in Excel & Powerpoint
- Demonstrated results building partnerships with multi-levels across businesses
- Knowledge of local country, strategic and financial concepts, compliance and tax principles are an asset
- Excellent interpersonal skills and the ability to communicate effectively, both written and verbally
- Strong analytical and business partner skills, customer oriented and strategic mindset
- Result oriented with strong prioritization skills and accuracy also under pressure
- Able to deal with complexity, with the right level of attention for details and without losing the bigger picture
- Positive and curious mindset
- Self-starting and proactive
- Able to create an atmosphere of trust and mutual respect
7
Medical Devices Market Access Director Resume Examples & Samples
- Lead the design and development of projects and services that facilitate access to the market of the various products , in line with the business priorities, creating a center of excellence and transferring the culture of Health Economics within the marketing and sales departments
- Support the franchise ensuring the maximizing offers by J&J with studies related to cases and significant diseases while promoting feedback of Health Economics and Health Technology Assessment
- Coordinate activities of Health Economics specialist
- Develop Market Access skills within the department
- Ensure the full alignment of activities with the European business Health Economics & Reimbursement
- Support into the Horizon Scanning and develop the strategic plan development of JNJ at country level
- At least 5 years of professional experience
- University Degree in Economics, Business Administration and or Relevant Technical and/or Scientific Subject
- Post graduate Master, Diploma or equivalent courses and/or experience with the exposure to how National Health Care System, National and Regional bodies interact on relevant HC decisions
- Market Access Experience
- Italian speaker with English proficiency
8
Portfolio Management, Medical Devices Resume Examples & Samples
- He/she will refine and analyze project-level data to drive platform and franchise-level decision-making, build visuals and data to enable presentation of scenarios to enable senior leadership to make informed decisions regarding investment allocation choices, and projected financial and strategic impact of those choices
- The Portfolio Analyst will have a demonstrated ability to effectively deliver results as an individual contributor, while also collaborating with cross-functional teams to deliver business objectives
- He/she will assist in the development and refinement of market insights to identify strategic opportunities
- The Portfolio Analyst will perform analyses and evaluations of opportunities to generate portfolio recommendations using a combination of competitive research, primary market research, and market modeling
- This individual will develop an understanding of global regional user needs, and strategic recommendations for delivering clinical and economic value to consumers
- A Bachelor’s Degree and MBA is required, along with 3 years professional experience
- Experience in Medical Device industry is preferred
- Ability to manage data and apply a variety of analytical techniques to derive insights from a set of objective and subjective data inputs is required
- Experience developing business cases for products or services is preferred
- Experience in market segmentation analysis, stakeholder requirements, competitive landscape assessment, unmet needs analysis, and market modeling is preferred
- Successful portfolio experience is preferred. Experience with forecasting and market modeling tools and statistics is preferred
- Proficiency in MS Office (Word, Excel, PowerPoint) is required
- Exceptional communication skills are required
- Must be a team player, willingness to collaborate with cross-functional teams to constructively challenge and cooperatively make improvements
- Be self-motivated and have the ability to aggressively pursue solutions to key challenges with a strong sense of urgency is required
- Strategic thinking and problem solving skills are required
- This position is preferably based in Raynham, MA, or in New Brunswick, NJ or West Chester, PA, and requires up to 20% travel.R&D
9
Complaint Analyst / Medical Devices Vigilance Resume Examples & Samples
- BS degree in science/medical related field is required
- 2-3 years experience within a regulated medical device/clinical environment is preferred; or equivalent combination of education and experience
- English proficiency oral and written is a must
- Must have adequate computer skills/computer based software to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate. Ability to communicate with affiliate in additional languages is an asset
- Occasional travel will be required
10
Medical Devices Technical Specialist Resume Examples & Samples
- Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes
- Deliver technical reviews and certification scheme management in support of CE marking
- The jobholder will be a member of the Orthopaedic & Dental Team reporting to the Certification Lead in Germany and work as a colleague with other members of the Medical Devices Business Stream. Effectiveness will come from application of personal authority and expertise rather than hierarchical position
- Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise relating to non-active dental medical devices and orthopaedic medical devices
- Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel
- Provide “Technical Sales/Networking” support to the commercial team and promote BSI
- Provide in-house and external training for orthopaedic & non active dental medical devices
- There is interface with and a need to influence all levels of the BSI organisation and at all levels of management in client and regulatory organisations
- Work with technical team leaders as required
- Participate in client meetings to facilitate CE marking processes
- The position is office-based in Frankfurt. It will involve travel to BSI in UK and third party locations mainly in Europe and when required around the globe for business and representative meetings
11
Junior Specialist, Production Medical Devices Resume Examples & Samples
- Responsible for the timely execution of production orders
- Also responsible for the development of the process coated implant together with the Department of Process Engineering
- Working under cGMP, applying cGDP
- Responsible for compliance with the standards in relation to the handling of chem./pharm. substances
- Responsible for the planning and execution of the maintenance of the production facilities
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs, and other relevant conditions
- Education qualifications in the pharmaceutical or chemical field
- Entrance examination in safety of the substances to be processed
- Experience in GMP / GDP environment
- Working with pharmaceutical substances in the clean room
- Regular occupational medical examination
- Additional duties as directed by supervisor
- Very good knowledge of German and good English skills
- Other personal attributes: organizational skills, initiative, assertiveness, teamwork and resilience
12
Manager, Medical Devices Resume Examples & Samples
- Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals
- Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc.)
- Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports
- Contributes to the development and monitoring of area budget through regular analysis of cost and spending
- EXPERIENCE WITH MEDICAL DEVICES
- Experience with developing a team of engineers: coaching, mentoring, 1-1s, and performance management
- Sustaining Engineering experience required in high volume manufacturing, preferably in the medical device industry
- Firm understanding of GMP, quality system requirements and CAPA
- Excellent problem solving skills, demonstrated critical thinking and use of statistical methods. Six Sigma certification desired
- Exceptional interpersonal skills: Self-directed, demonstrated success in highly collaborative environments, demonstrated ability to influence positive change and communicate clearly at all levels in the organization
- Demonstrated systems level leadership and strategic planning skills
- Knowledge of process validations, risk management, equipment development/qualification/maintenance/calibration desired
13
Program Manager, Medical Devices Resume Examples & Samples
- 3+ years of experience in program administration/management or related area
- Experience in electromechanical product development including mechanical, electrical and software design
- Bachelor's degree in engineering or related field or equivalent experience
- PMPI certification
- A Master’s degree is preferred
14
Senior Process Engineer, Medical Devices Resume Examples & Samples
- 8 to 10 years of experience in process or manufacturing (Medical Desire), EMS projects, box build, high level integration
- Bachelor's Degree in Engineering
- R&D experience required
- Experience with pump systems including Insulin devices, drug delivery systems
- Fluency in Spanish or Mandarin
- Experience in medical device NPI
- Statistics tools
15
Account Manager Farma / Medical Devices Resume Examples & Samples
- You are in the center of complex sales processus
- You proactively follow and analyze market evolutions
- You create partnerships with different actors within the decision process
- You analyse market information and conduct meetings with the targetgroups in order to identify the partnership possibilities
- You attend international congresses
- You contribute to the account plannings in order to obtain the best results
- You deliver customer focused service to further develop the relationship
- You keep track of your knowledge (pharmacology, products, market, competitors, communication techniques) through participation to trainings and conducting regular selfstudies
- Preferably a master degree, scientific background
- 5 years experience in a job related function within the pharmaceutical/medical market
- Proven sales trackrecord
- You are a networker and have a proven track record on maintaining professional relations; an existant network within the target group is a plus
- Extended knowledge of the Dutch Health Care market
- Excellent knowledge of Dutch and English
- Driver’s license B
- Ability to manage and solve complex situations
- Strong relation & network builder
- Analytical and problemsolving
- Good communicative and interpersonal skills
- Empathetic ability & teamplayer
- Good organizatorial skills
- Pro-active, independent and flexible
- Result-oriented, customer focused and enthusiastic
- Systematically reflect on own behavior and experiences
- Healthy dose of perseverance
16
Human Factors Engineer for Medical Devices Resume Examples & Samples
- Provide human factors expertise in a broader cross-functional development team including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, generation of hardware and software design concepts, user interface specification, and instructions for use in compliance with both company quality assurance standards and applicable regulations
- Evaluate and challenge of technical solutions
- Design, plan, perform, interpret, and report results of formative and summative human factors studies
- Define appropriate sample sizes and statistical methods for analysis of human factors activities
- Perform anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development
- Lead design of user instructions, including validation
- Lead/support creating of internal procedures and templates for the execution of human factors engineering research
- Proactively support collaboration with internal and external partners which includes monitoring of work progress according to plan
- Support/coach of team members, participation in sub-teams, and contribution to overall strategies and goals
- Work independently and proactively against self-set targets when necessary
- Develop relationships with key vendors
17
Developer Connected Wearable Medical Devices Resume Examples & Samples
- Insight creation (device functionality, disease management, device status,…) ; translation into customer requirement document
- Medical device HW adjustments (Bluetooth module integration)
- Application architecture
- Application build
- Application V&V – basic safety, privacy, EMI/EMC, data protection,
- Application release
- Medical device development – connected devices
- Impact of connected device on Safety Hazard analyses
- IT-platform for next generations L&H products
- Working in multi-disciplinary / multi-cultural team
- End-to-end development (from idea to market launch)
- Relationship established with Connected Group within Philips
- Master degree in
18
Program Manager, Medical Devices Resume Examples & Samples
- Organize, plan and direct program schedules and budgets
- Responsible for tracking relevant metrics and drive action items based on results
- Provide support, knowledge and expertise with contract negotiations as required
- Oversee all interdepartmental activities ensuring completion of all commitments made relative to product development timelines, delivery, quality and the required business metrics
- Reviews program proposal or plan to determine time frame, funding requirements, procedures for accomplishing program, staffing requirements and allotment of available resources to various phases of program
- Establishes work plan and staffing for each phase of program, and arranges for recruitment or assignment of personnel
- Manage the coordination of product life cycle activities with P&L and customer satisfaction and have responsibility for accounts of various complexities
- Lead the project with cross functional team of engineers through various product life cycle phases
- Be the key channel of communication for customers and act as escalation in the event of customer issues
- Responsible for customer satisfaction reviews and corrective actions
- Maintain current and develop additional business with customers
- Monitor and track that project and program deliverables are met
- Be responsible for maintaining excellent customer relations with both new and existing customers
- Support production sites for projects, costs and other customer related matters through leadership and expertise
- Coordinates program activities with activities of government regulatory or other governmental agencies
- Implement appropriate HR Strategies and actions to recruit and retain a qualified and motivated workforce
- Participates with functional managers in establishing strategic organizational plans and objectives
19
Medical Devices Resume Examples & Samples
- Develops implements and evaluates the comprehensive strategic Communications and Public Affairs framework and concepts based on specific market, country and community requirements
- Serves as a member of the Country Leadership Team and thereby contributes to the overall country strategic direction
- Builds strong alliances with other functions (e.g. HR) to foster productive collaborative partnerships
- Ensures that all interactions and communications are aligned with the established strategic positioning for products within the business units and against MD at EMEA and Global level
- Identifies and responds to issues and trends of strategic importance
- Manages BP Process for communications budget forecasting & project allocation. Allocates country budgets, based on local country-level communications requirements and is accountable for the achievements and budgets as agreed within the BP
- Manages and develops a small team of communications professionals at country level
20
Contracting Manager Medical Devices Resume Examples & Samples
- High energy and willingness to work in an environment where priorities and focus can change routinely
- Analytical and problem-solving skills, including basic knowledge of financial and statistical information
- Ability to put cohesive presentations together in PowerPoint
- Be able to present confidently in large groups and in front of superiors
- 3 – 5 years of relevant healthcare or industry experience
21
Test Lead Engineer, Medical Devices Resume Examples & Samples
- 5+ years of experience in leading complex software testing projects and other tester
- 5+ years of web and test automation experience
- 2+ years of experience in Agile software development and testing
- 2+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software development
22
Life Sciences Medical Devices Resume Examples & Samples
- Self motivated and target driven
- Attention to maintaining excellent quality of work
- Technical excellent/ expertise
- Strong team-worker - effective relationship builder
- Strong selling and influencing ability
- Technical insight
23
Manager, Medical Devices Resume Examples & Samples
- Interprets and executes policies that affect work processes and personnel within the assigned organizational unit
- Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc)
24
Analytics COE Medical Devices Lead Resume Examples & Samples
- Drive reengineering, standardization, harmonization of reporting solutions for all applications/systems in scope
- Establish, govern and ensure adherence to cross-divisional/systems reporting standards
- Establish and execute governance boards in partnership with teams and business groups
- Follow the industry trends and address new business needs for Medical devices business unit
- Provides excellent subject matter expertise and develops an environment, which fosters innovation
- Defines and governs solutions inventory and leverage this inventory to ensure high reusability of the solutions
- Ensure execution of projects within the team on time, on quality and costs, including management of vendors
- Achieve the most efficient analytics Solutions (best in class) providing highest business value through effective management of resources
- Partners with key stakeholders to define opportunities and identify Business Intelligence Solutions based on predefined criteria (e.g. return on investment, productivity, compliance)
- Acts as trusted advisor driving decisions, priorities and relevant project information aligning with appropriate levels of staff regarding business needs, projects and initiatives
- Proactively shares knowledge of technology risks and opportunities to build competitive advantage and improve efficiency and effectiveness of business units
- Ensure compliance of all designed solutions to all relevant internal/external requirements (e.g. FDA, Novartis IGM framework)
- Manages, coaches and oversees internal and external resources in line with their targets, roles and responsibilities and the Novartis values & behaviors
- Be a team player within Analytics COE
- Education: University degree or equivalent
- Languages: English – fluent spoken and written. Further languages preferred
- Experience: At least 20 years of experience in Business and IT
- Proven leadership skills with the ability to drive diverse, geographically dispersed teams to deliver against milestones
- Ability to cope with complexities, ambiguities and matrix organizations
- Strong knowledge of Business Analytics and Data Warehousing strategy, concepts, and architecture. Experience in Big data is a plus
- Excellent understanding of Finance, Commercial, Manufacturing, Quality and Supply chain processes and compliance requirements
- Strong knowledge of project methodology
- Proven experience to present new concepts, project objectives, progress reporting, and facilitate review meetings with executive and senior audience while demonstrating strong business acumen
- Able to ensure integration among project team members and other Business and IT team members
25
Risk Manager, Medical Devices Resume Examples & Samples
- Ensures that all hazards associated with a medical device are identified, the associated risks are estimated and
- Ensure that risk management reports are prepared in a timely manner and in accordance with ISO 14971 and applicable Sanofi SOPs
- Good knowledge of usability engineering or human factors engineering for medical devices
- Proficient in usage of risk assessment methods, e.g
26
Director Medical Devices Cleveland Clinic Ventures Resume Examples & Samples
- Evaluates business opportunities related to Cleveland Clinic developed technologies by analyzing product development status, customer needs, market factors and resource requirements
- Assists and mentors Cleveland Clinic inventors in critical business formation decisions which will include sharing project planning and management skills in order to nurture internal teams involved with the development of potential new companies
- Helps Cleveland Clinic startups raise funds to accelerate technology commercialization. The funds should be milestone driven that lead to an investment from a high performing Venture Capital firm
- Assists in creating the initial business model, engaging the founders and/or management team and securing initial funding to accelerate the business formation process which will include connecting start-up projects to relevant resources both internal and external to Cleveland Clinic
- Coordinates activities with all others in the Cleveland Clinic commercialization teams and participates in the ongoing development of Cleveland Clinic Ventures by fostering on-going external relationships with entrepreneurial and venture communities
- Identifies and reports forward looking Key Performance Indicators for companies for stakeholders related to the CC startup entities
- Works with the Devices Advisory Council to determine feasibility, success factors, and potential commercial pathways for potential spin-out companies
- Manages a portfolio of existing Device companies as a board member or observer to achieve the highest possible financial return
- Prepares analytical reports on portfolio companies for internal/external stakeholders
- Enforces Cleveland Clinic policies and procedures for Cleveland Clinic startup companies, and reviewing Cleveland Clinic startup corporate agreements for accuracy
- A minimum of 5 years of business formation experience with new product development in the medical device market, including a minimum of 3 years of demonstrated management experience
- Experience negotiating term sheets valued more than $10 million with top Venture Capital firms and an understanding of the technology transfer licensing process to startup companies is a plus
27
Co-op-polymers & Medical Devices Resume Examples & Samples
- Responsible for using appropriate sample preparation methods for materials analyzed by different techniques, compiling of the test results while working under supervision
- Responsible for the tasks related to technical work documentation
- Conduct routine testing and customized testing
- Responsible for complying with all aspects of Exova’s procedures and policies including Health and Safety, quality and GMP practices where required and will alert the area manager should problems or issues arise in those areas
- Provide additional support to the laboratory on as needed basis
- Interpret and report testing results, as required
- Assists in the design and fabrication of custom project equipment and/or test fixtures
- Performs additional related duties, as assigned
28
Accountmanager Medical Devices Resume Examples & Samples
- Master’s degree in relevant area
- At least 5 - 7 years of marketing or sales experience in a pharmaceutical company or medical nutrition company or relevant experience in a role in a medical context (hospital / care home)
- Proven entrepreneurial mindset
- Preferably you have worked in the past already with Medical devices and have acquired certain expertise in enteral feeding
- Driving and influencing skills: because in our matrix organization with demanding external stakeholders will be the key to your success
- Thinking ahead: because preventing issues from becoming problems will give us our competitive advantage. This also means that at one moment you will be working on the shaping the strategy for Flocare when the next day your focus will be on solving – as “second line expert” a practical issue that one of our clients is experiencing
- Pioneering in new areas for growth and tapping in new stakeholders to ensure we stay ahead of competition
- You are authentic in building your relationships, credible through your expertise proven ability to deliver on promise or even beyond
29
Director Medical Devices Ehealth Resume Examples & Samples
- Provide expert advice to the TAs, R&D, and Business Units regarding Medical Devices, Electronic Data Capture, Human Factors Studies and eHealth
- Provide consultative services for the development of a global clinical strategy and the operational conduct of global clinical development activities concerning Medical Devices, Electronic Data Capture, Human Factors Studies and eHealth, including for NMEs Phase IIII and for marketed products, with the aim to optimize product value (e.g. new indications, new formulations, etc.)
- Contribute to managing the Bayer R&D portfolio of the Indication Area by providing expert input on Medical Device and eHealth opportunities, including the search, evaluation, and execution of licensing opportunities with regard to Medical Devices
- Contribute to the ongoing analysis of the external landscape regarding Medical Devices, Electronic Data Capture, Human Factors Studies and eHealth
- Actively participates in relevant committees and meetings for innovation sourcing, establishing relevant linkages between collaboration projects and internal projects, and presents projects at relevant management meetings
- Design and manage data models with scientific applications to development in support of the short and long term R&D strategy, while maximally leveraging existing internal R&D know-how
- Innovate with data models, data integration, calculation approaches, analysis methods, algorithms, and other related tools to support the development of digital health platforms and solutions
- Assist in maximally exploiting Bayer assets in and associated with the fields of computational life science by promoting and actively seeking cooperation and exchange with scientific departments
- University degree of M.D., or Ph.D., or both. Ph.D. should be in a natural science or scientific discipline
- At least 5 years of relevant experience with Medical Device development
- In depth expertise and experience in the fields of Electronic Data Capture, Human Factors Studies, and/or eHealth
- Knowledge and experience in big-data handling and digital health, as well as advanced analytics (e.g. data analysis, forecasting, etc.) and web-based applications
- Knowledge and experience with the Medical Device and eHealth regulatory environments, especially in the U.S. and EU
- Strong aptitude to set a vision for data capture, data analysis, and data application in the fields of Medical Device and Pharmaceutical development, approval, launch, improvement, and support
- Excellent presentation and organizational skills
- Skillful in negotiating and exerting influence, especially without authority
- Experience in the management of collaborations as well as in project management
- Outstanding track record of leading teams
- Excellent networking abilities with a high degree of credibility and integrity
- Excellence in dealing with ambiguity
- Strong strategic skills with good business acumen
- Self-assured and comfortable defending positions with management
- Ability to embrace change
- Good emotional skills and personal insights
- Fluent English skills
- Ph.D. should be in a natural science or scientific discipline (e.g., theoretical chemistry or biology or physics, bioinformatics, cheminformatics, computer engineering, electrical engineering, mechanical engineering
- Post-doctoral training and/or degree in engineering, computer science, statistics, epidemiology, or regulatory science
- International and intercultural experience and ability to work effectively in multicultural environments; International experience in Europe and North America
- Ability to speak German
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Director Medical Devices Ehealth Resume Examples & Samples
- Participate in relevant committees and meetings for innovation sourcing, establish relevant linkages between collaboration projects and internal projects, and present projects at relevant management meetings
- Assist in maximally exploiting Bayer assets in and associated with the fields of computational life science by promoting and actively seeking cooperation and exchange with scientific departments within R&D as well as the computational community within Bayer
- University degree of M.D., or Ph.D., or both. Ph.D. should be in a natural science or scientific discipline (e.g., theoretical chemistry or biology or physics, bioinformatics, cheminformatics, computer engineering, electrical engineering, mechanical engineering, or a related field)
- International and intercultural experience and ability to work effectively in multicultural environments
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Innovation Director, Medical Devices Resume Examples & Samples
- Scientific and/or Technological background combined with business-savvy thinking (preference medical doctor/PhD/Scientific Medical Expert): 8-10 years’ experience minimum
- Investment Ecosystem and Climate Awareness at Country Level. Network and Connectivity to Country Ecosystem Stakeholders. Ability to scan for medical and healthcare environmental trends, opportunities and threats
- Strategic Orientation aligned with organizational objectives. Customer and solution -oriented. Ability to present scientific and R&D activities appropriately to other functions
- Strategic and strong influencing and shaping skills internally & externally
- Comfortable with ambiguity and complexity
- Ability to work effectively in a matrix environment and to lead multiple functions where required
- Passion for innovation, value creation and ecosystem impact; Ability to keep on learning and extrapolate accurately from scientific medical expertise
- Deep alignment with the J&J CredoMarketing
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Quality Expert for Medical Devices Resume Examples & Samples
- Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure Good Manufacturing Process compliance
- Accountable for monitoring, analysis and reporting of Good Manufacturing Process related Key Productivity Indicators as part of management reporting
- Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies
- Release of medical devices for clinical studies and commercial use
- Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients
- Represent Medical Devices Quality in initiatives and cross-divisional projects
- Lead project related activities (e.g. development of new tools, processes)
- Perform or support inspections and audits as required
- Provide support to Biologics Technical Development & Manufacturing line functions in Good Manufacturing Process compliance related issues in area of expertise (e.g. Medical Device standards)
- Coach and develop people; participate in recruitment of talent. Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans
- Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory Good Manufacturing Process guidelines, health authority requirements, Standard Operating Procedures, Health, Safety & Environment, etc.). Promote and enforce compliance to guidelines. If managing associates, ensure same for them
- Support project management functions as a sub-team member in preparation for a Pre-Approval Inspection
- Write/contribute to internal compliance policy and/or comment to regulations
- Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process
- Ability to influence people, negotiate and communicate
- Sound scientific, technical and regulatory knowledge in a specific area
- Excellent knowledge of Good Manufacturing Process, working knowledge of medical device and combination product regulations, standards and guidelines. 5. Good knowledge of medical device development and life-cycle management
- Good and proven ability to analyse and evaluate Good Manufacturing Process compliance
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Manager of Program Management Medical Devices Resume Examples & Samples
- 10+ years experience in a Program/Project Management role
- 3+ years experience in Management or leadership role
- Bachelor's degree in engineering or related field or equivalent experience. A Masters degree is preferred
- Experience in managing product development projects in regulated environment such as medical devices
- Comprehensive understanding of product development, from design to NPI to supply chain to manufacturing operations in medical device industry
- Ability to interface and communicate with different levels of the organization, both at customer & Flex
- Strong analytical capabilities and attention to detail. Ability to dig deep into issues when needed
- Experience managing commercial issues (price, contract terms, cost recovery claims, etc.)
- Both OEM product company and EMS company experience
- Experience working with across time zones / regions
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Global Product Manager Medical Devices Regulation Resume Examples & Samples
- To implement the new Medical Devices Regulation (MDR) within all SGS Notified Bodies (CE0120, CE1639, CE0598) and the SGS network
- To have overall responsibility for the successful management of the MDR ensuring the global operation is efficient and meets the expectations of internal customers (affiliates), external clients, scheme owners and accreditation bodies
- To ensure global internal and external KPIs are met and all relevant approvals and accreditations are maintained to safeguard the SGS business and reputation
- To provide overall commercial strategy/guidance for affiliates to faciliate product growth in key countries and regions
- To monitor market trends and track competitors' products to help improving the efficiency of the global business growth strategy
- Ability to manage high level projects with cross functional and multicultural teams
- Ability to communicate effectively at all levels within the company including senior management, technical and commercial teams
- Market savvy and strong customer focus
- Excellent technical competency and understanding of Medical Devices technologies and regulations
- A solid understanding of accreditation requirements
- Excellent interpersonal and influecing skills
- Negotiation and persuasion skills
- Change Management skills
- Strong organizational skills and flexibility
- Complete integrity and understanding of the need for risk management of SGS activities
- Strong people management skills
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Digital Expert Medical Devices Resume Examples & Samples
- Implementation of the new Dunlee Corporate Design to all communication channels. Develop and execute ongoing further activities for PR, Print, Social Media, Website, and Intranet within the guidelines of Philips, to maximize the contribution of this sales tool
- Translates the marketing objectives into a yearly MarCom plan, specifying required deliverables and projects, according to the guidelines
- Promote and drive your capability expertise to be leveraged for the digital marketing strategy
- Own the digital capability roadmap and budget to drive maximum ROI on the various executions across the various touchpoints in the respective customer decision journeys
- Coordinates, realises and/or supports the presentation of the products on exhibitions, organises events and press conferences and controls the hired stand builders Prepares materials for internal and external presentations on products
- May work with multiple agencies and contractors and evaluates the performance of these vendors as appropriate
- Make sure that the MarCom deliverables, like manuals and product information, is available in the required languages, in order to successfully introduce and promote products and compete with the competitors
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Process Engineering Manager Medical Devices Resume Examples & Samples
- 8 to 10 years of experience in process development/manufacturing in the medical environment
- 3 to 5 years of management experience
- Statistics tools (minitab)
- Bachelor’s degree in Engineering
- Experience with medical design development phases (Feasibility, Characterization, Design Verification, Clinical and PQ Production)
- Ability to travel 25% of the time
- Lean Manufacturing
- SOP Development
- FDA 21 CFR 820 / ISO 13485
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Medical Devices Resume Examples & Samples
- Software Driven Medical Devices
- Class II/Class III Medical Devices
- "Combination" Medical Device/Pharma/Disposables Products
- What will you do at Fresenius?
- 3+ years’ supervisory or project/program management experience preferred. Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments
- Experience with international regulations preferred
- Demonstrated working knowledge of scientific principles
- Demonstrated ability to work effectively in a highly charged, fluid environment
- A self-starter with the ability to work as a Project Leader managing projects and allocation of resources to those projects
- Very detail-oriented, well-organized, and driven to meet deadlines and program goals
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Vigilance Specialist Medical Devices Resume Examples & Samples
- BS/BA degree in business or science with 1 to 3 years experience within a regulated medical device/clinical environment; or equivalent combination of education and experience
- English proficiency oral and written, must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate; including
- Interpersonal skills – interact with all levels, personalities, cultures & disciplines of organization to produce required results
- Investigative & analytical – to establish possible options for action
- Results oriented – in a fast paced environment
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Senior Program Manager, Medical Devices Resume Examples & Samples
- Overall ownership and responsibility for program results (scope, schedule, budget, quality). This includes product development core team leadership of project / program lifecycle activities and general project and process initiatives
- Lead cross-functional project team through the full program or project lifecycle
- Lead product and process development efforts, and coordinate with core and extended team members from R&D, marketing, quality, regulatory, clinical, operations, supply chain, and other functions as required
- Negotiate program expectations and ensure results are achieved
- Maintain and forecast project budgets and resource allocations
- Report program and portfolio strategy and status to the executive leadership team
- Coach and mentor other Program and Project Managers
- Play a key role in the establishment of strategy and standard practices for program management
- Minimum 10 years engineering experience in medical device or diagnostic industry
- Minimum 5 years in a Program Manager role
- Strong understanding of product /project life cycle management and process development
- Ability to think strategically at the program and portfolio level
- Ability to effectively communicate, influence, and facilitate at the executive level
- Understands and enforces Quality System requirements
- Keeps abreast of trends, competitive activity and new technologies
- Proven ability to manage program scope, schedule, risks, and budget and hold team accountable for results
- Strong motivation and ability to self-start
- Proven ability to work and build relationships cross functionally
- Ability to coach/mentor Program/Project Managers
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Technical Director, Medical Devices Resume Examples & Samples
- Development of technology strategy & roadmap to support our business plans in the industry
- Overseeing the development and delivery of technology innovations for core & emerging technologies, including effective investment of development resources
- Ensuring that the R&D team have the right skills, training & development plans to meet their objectives
- Taking part in visits to potential customers alongside the Commercial team to secure strategic outcomes, and provide technical support and expertise to the customer
- Responsibility for the Company’s IP and know-how asset base including the creation of a coherent patenting strategy
- Educated to at least a Master’s degree level, or equivalent, in a technical subject relevant to the development of medical devices
- A proven track record in Medical Device management and leading R&D project delivery
- Expertise in innovation strategies, systems, programmes, and tools
- Significant experience in Building Organisational Talent, and Coaching and Developing Self and Others
- Familiarity with NPI frameworks and systems for Innovations
- Customer Focus and the ability to proactively building collaborative relationships
- Understanding of Intellectual Property legislation and the patent process
- Ability to travel extensively internationally and to work flexible hours when necessary
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Technology Head-medical Devices Resume Examples & Samples
- Proficient in SQL Server or Oracle database, .NET technology or cluster/cloud architecture. More than 5 years related working experience
- Systems/requirement analysis and design capability, can make overall planning independently, can make technical specification
- Responsible for configuration management
- Experience in PACS RIS, , HIS or other information systems in hospital
- Atleast managed ERP (Preferably SAP) implementation -for 3 projects
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Collaboration Manager Medical Devices Resume Examples & Samples
- As the Collaboration Manager you will report to the Head of Advanced Development and work as part of the Advance Development team focused on working with collaborators to bring ultrasound innovations to market
- You will manage the research and product development collaborations with research Siemens ultrasound
- You are the project owner and primary contact for university collaborators and you are able to cultivate the best and most productive key researchers and universities for Siemens Healthineers
- You will work with the Ultrasound organization and site Principle Investigator to execute collaborations. This includes protocols, approval forms, legal collaboration agreements, monitoring progress and ultimately closure
- Besides this you will work with other functional organizations such as legal, compliance, finance, logistics and assistants on the University side to successfully execute collaborations
- You will provide written feedback to Advanced Development, product and senior management regarding project results and new project ideas from the field
- You hold an BSc degree and you have many years of professional experience
- You already worked for a commercial diagnostic ultrasound company and have strong understanding of clinical applications of ultrasound technology in diagnostic imaging including standard imaging modes (e.g., B-mode, Doppler) and advanced imaging features (e.g. elastography, shear wave imaging), experience working with clinicians to develop/improve ultrasound imaging capabilities is a plus
- You have experience in preparing and presenting features as well as preparing clinical study protocols as part of securing regulatory approvals (e.g. IRB or Ethics Committee)
- An understanding of regulatory requirements governing medical device design and development as well as a familiarity with commercial system offerings and market trends is also desirable
- You have the ability to communicate with clinical experts and translate clinical needs into requirements that meet or exceed clinical needs as well as to effectively communicate, both oral and written English, across a broad range of interfaces including Siemens staff and external partners
- You are able to work and manage time independently as a remote employee and you are willing to travel up to 50% to attend internal workshops, medical conferences, and support collaboration projects at remote sites
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Medical Devices Digital Marketing IT Lead Resume Examples & Samples
- Agile User Requirements: Works with business partners to identify/document/translate requirements for IT sprint cycles and in a consumable format and terminology for developers (includes user stories, acceptance criteria, wireframes…etc). Explains to the business how requirements may be implemented from a functional standpoint
- Roadmap Generation: Develops a future data roadmap for systems or capability areas within their area of responsibility. Understands an IT system or systems that the business partner group uses, maps out business processes to serve as reference for development and IT support
- Applies compliance requirements within scope of responsibility, provides documentation and participates in compliance activities as required
- Program Oversight: Report on the progress of workstreams within scope of responsibility
- BA/BS degree with a minimum of 6+ years of relevant IT experience OR 4+ years with advanced/master’s degree or equivalent is required
- Has current knowledge of industry and business process trends related to Digital Marketing
- Has domain knowledge of Marketing Function and experience developing/configuring IT solutions for key processes within Digital Marketing
- Experience with Agile methodologies, including user story creation, backlog prioritization, coordination with scrum teams and UAT is required
- Quickly learns business and complex processes, along with ability to understand and work across multiple business domains in support of projects
- Strong communication and critical thinking skills
- Ability to partner with development teams
- Experience implementing Web Sites, digital marketing campaigns, and web analytics
- Experience working with cross-regional/global IT and Cross-Functional Teams
- Must have excellent communication skills (written and oral)
- Must be skilled in building strong cross-functional partnerships
- Experience with leading multi-company teams and global efforts are preferred
- Demonstrated ability for a rapid understanding of business processes, and their technology implications
- Knowledge of enterprise architecture and development methodologies preferred
- Proven experience in best practices in: Digital Marketing (Web, Digital Asset Management), eDetailing, Demand Forecasting, Brand Management, Product Pricing, Channel Management, Marketing Innovation and Marketing Insights/Analytics is preferred.4292170621
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Senior Process Engineer Medical Devices Resume Examples & Samples
- Experience with NPI (New product introduction) environments
- Line Transfer, feasibility builds/studies and Characterization builds/Studies
- Experience in process development/characterization
- Testing Procedures, Leak test, Pull test, Pressure test, Vacuum test, Aging Test, Cross Section, destructive test, etc
- IQ / OQ / TMV PQ specifically for medical product development environment
- Gauge R&R evaluations
- PFMEA
- Lean manufacturing concepts
- Quality systems knowledge
- Availability to travel 25%
- Basic knowledge of semi-automation Vs automation processes
- Strong Minitab skills
- At minimum of 8 years of experience in process manufacturing
- Requires a Bachelor’s degree or equivalent in Electrical or Mechanical Engineering
- Only current contractors working at the FLEX – Irving Design Center will be considered
- In addition, all contractors considered for this position must have at least 6 months of experience performing planning, design, programing, simulating, and development, in conjunction with a multidisciplinary engineering team, automated electro-mechanical mechanisms and controls packages to operate machines and equipment for manufacture and assembly of medical devices
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Key Account Manager Pharma / Medical Devices Resume Examples & Samples
- Be empowered to create innovative solutions
- Engage and influence valuable QuintilesIMS customers
- Let’s move healthcare forward. Together
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VP, Head Epidemiology Medical Devices Resume Examples & Samples
- Providing methodological guidance and mentorship on a wide range of studies and issues, to the MD and other J&J sectors, at a high level, to ensure alignment on project requirements, and provide appropriate direction to the members of the MD Epidemiology group as well as partnering organizations
- Leading and crafting partnerships with a range of external research organizations, becoming a value-adding partner of the emerging external community around real world evidence
- Promoting and championing scientific rigor and openness within Epidemiology research related processes and standards. Inspiring innovation at all levels, and in all aspects. The Head will continuously and critically examine the real world evidence capabilities (processes, talent, data assets and partners, IT infrastructure, etc.), to affirm their adequacy in enabling premier product development and in meeting critical unmet medical needs around the world
- You are a PhD or MD with training and degree in Epidemiology or a related field (e.g., Health Services Research, Health Economics, Biostatistics, etc.) with 10 or more years of Epidemiology research experience
- A well respected scientific leader with an established reputation at the national (minimally) or international (preferred) level with a record of publication in peer-reviewed journals
- Possessing global experience within the Pharmaceutical or Medical Device industry and specifically within Phase III/IV
- Convey a sophisticated understanding of, and the capacity to, interpret quantitative methods
- Expertise in writing statistical methods sections of study proposals/requests or background epidemiologic material on specific diseases, conditions, or therapies
- Experience working with large administrative or medical records databases as well as health authorities
- Dynamic people leadership with direct or matrix management of other scientists is needed
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Technical Lead-medical Devices Resume Examples & Samples
- Instrument improvements projects/activities e.g. feature enhancements and design optimisations based on customer feedbacks
- Instrument product care/sustaining activities
- Instrument design transfer projects (development and in-sourcing)
- Design Control and design documentation
- Product Validation and Human Factor Engineering activities
- Lead technical activities, projects, competence initiatives, organizational process development within our technical area
- Design responsibility for marketed instruments including design control activities
- Plan and execute on sustain activities across the organisation
- Complaints handling including root-cause-analysis and mitigation activities
- Securing good mechanical design, serviceability and manufacturability during instrument development and enhancement projects
- Ensuring that our marketed instrument products are in compliance with regulatory requirements
- Plan testing and test execution as part of verification
- Documentation according to internal and regulatory requirements
- You most probably have a background as mechanical or electronics engineer with experience in engineering design, product development and sustaining/maintenance
- You have a strong technical understanding, and you have experience with design controls incl. requirements engineering, design verification, change control and safety risk management
- You will work in an international environment, hence solid skills in English is a must
- In addition, you are preferably skilled in and have experience with robust engineering design and root cause analysis
- You have a solid theoretical and practical experience with design and manufacturing of e.g. plastic parts and generally good knowledge of and experience with engineering materials
- 5 years of relevant experience
