Design Quality Engineer Resume Samples
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Design Quality Engineer Resume Samples
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DK
D Kirlin
Doyle
Kirlin
630 Veum Key
San Francisco
CA
+1 (555) 845 1786
630 Veum Key
San Francisco
CA
Phone
p
+1 (555) 845 1786
Experience
Experience
Boston, MA
Design Quality Engineer
Boston, MA
Bogisich-Tromp
Boston, MA
Design Quality Engineer
- Create and/or provide support in creation of Risk Management documents
- Provide quality systems leadership, oversight, and strategic guidance to drive quality initiatives and develop/improve procedures
- Work with Product Manager to manage new and current SKUs
- Develop and maintain a working knowledge of statistics
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues
- Ensure Quality Management System adherence to EN9100, EASA Part 21(G) and Part 145, and with customer approvals throughout the Product Development Lifecycle
- Establish and maintain software related Quality Management System (QMS) process and procedures
Chicago, IL
New Product Design Quality Engineer
Chicago, IL
Fadel, Jaskolski and Stoltenberg
Chicago, IL
New Product Design Quality Engineer
- Participates in the design of medical devices and components from design initiation through design transfer by representing Quality Assurance in all design and development project teams
- Leads multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis
- Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations
- Assists in the maintenance of design history files for assigned projects, adhering to Arthrex design control procedures and performing periodic reviews of design history files to assure timely design transfers
- Supports manufacturing suppliers through audits, corrective and preventive actions, assistance in on-site resolution of quality and process related issues
- Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Upper management
- Provides insight and assistance of implementing and maintaining Process Improvement and Optimization concentrating on proactive methodologies
present
Dallas, TX
Principal Design Quality Engineer
Dallas, TX
Wunsch, Kerluke and Smitham
present
Dallas, TX
Principal Design Quality Engineer
present
- Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
- Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report)
- Provide guidance and direction for sample size and statistical analysis of verification and validation test results
- Provide training to project teams on procedures, verification, validation, statistical methods and design controls
- Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases
- 15% Partner with external design/development and/or manufacturing partners on development activities, including risk management, quality planning, and design transfer
Education
Education
Bachelor’s Degree in Quality Engineering
Bachelor’s Degree in Quality Engineering
Carnegie Mellon University
Bachelor’s Degree in Quality Engineering
Skills
Skills
- Excellent attention to detail, strong organization skills, and ability to work independently and in teams
- Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills)
- Good knowledge in quality tools, methods and systems
- Able to deliver quality outputs under minimal supervision
- Working knowledge of applicable standards and regulations, including 21 CFR Part 820, Part 11, ISO 13485, IEC 62304, AAMI Standards, ISO 14971
- Understanding of basic molecular biology and bioinformatics desirable
- ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)
- Ability to work effectively in a team environment and build strong working relationships
- Basic computer skills (MS Office, Email, etc) with a strong background in MS Excel
- Ability to constructively challenge concerns and engage in transparent conversations
15 Design Quality Engineer resume templates
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1
Principal Design Quality Engineer Resume Examples & Samples
- 75% Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Lead design control gap assessments, remediation planning, and remediation execution as required
- 15% Partner with external design/development and/or manufacturing partners on development activities, including risk management, quality planning, and design transfer
- 5% Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle
- 10+ years of device product development and/or quality engineering, including a minimum of 4 in design quality, required
- Experience in leading design quality activities and influencing senior management required
- Experience with statistical and six sigma methods required, and Black Belt preferred
- Experience with risk management processes and tools required
- Experience with Class II or III medical devices required, and experience with implantable devices preferred
- Experience working with external contract partners for design, development, manufacturing, and/or testing required
2
Design Quality Engineer Resume Examples & Samples
- 4 year bachelor degree is required
- 5+ year of experience in Pre and Post texture plastic part quality analysis and failure modes
- 5+ years of experience in tooling, acid etching of prototype & production tools for texturing; matching acid etch texture to ‘Master’ plaques including texture minimization and washout for feasibility issues
- 6 months of experience in quoting (cost and timing) of plastic part manufacturing
- Must pass color test
- Bachelor's degree in engineering is preferred
- 8-10 years of experience in Tool Texturing of Injection Molds and Compression Molds ; Nickel Shells / Teflon plating processes / Tribocoating
- 3-5 years of experience in quoting tool texturing – cost and timing
- Experience in managing entire automotive programs from start to finish
- CAD and Mold Flow experience
- Detailed understanding of injection and compression tooling design/development and plastic part processes to determine root cause and issue resolution
- Detailed understanding of the Appearance Approval Report (AAR), Phased Production Part Approval Process (PPAP), Part Submission Warrant (PSW) requirements and Advanced Product Quality Planning & Control Plan
- Demonstrate the ability to resolve complex part color harmony / quality issues and effectively communicate to management
3
Senior Software Design Quality Engineer Resume Examples & Samples
- Bachelor’s Degree in Engineering with 5 years’ related experience in engineering and/or quality assurance in a regulated industry (e.g., FDA-regulated, FAA-regulated, DoD, CMMI ML 3+) or Master’s Degree in Engineering with 3 years’ related experience
- Working knowledge of embedded systems and /or application software
- Working knowledge of risk management (generation of software and system risk analysis), CAPA, and/or Design Controls
- Experience leading a project
- Medical Industry experience
- Ability to represent the department in frequent inter-organizational and outside vendor contacts
- Experience with embedded medical devices and hardware/firmware
4
Principal Design Quality Engineer Resume Examples & Samples
- 10+ years of quality engineering experience
- 6+ years of medical device engineering experience
- Strong familiarity with regulatory requirements (e.g. ISO 13485,CFR 820 & EN ISO 14971)
- Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis
- Familiarity with Hardware EE Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, IEC 61000, Design of Experiments & Reliability Analysis
- Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis
- ASQ CQE, CRE, CSQE certification desirable, but not essential
- Test plan development and root cause failure analysis
- Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS
5
Senior Embedded System Design Quality Engineer Resume Examples & Samples
- 7+ years of experience in Design Quality Engineering of class II or III with embedded software in the medical device field
- Demonstrated competency of 21 CFR 820, MDD/CMDR, ISO13485, ISO 14971
- Understands and can subsequently explain complex quality details to non-experts
- Exceptional organizational skills
6
Design Quality Engineer Resume Examples & Samples
- Minimum three years (Engineer ) or 6 years(Senior Engineer) experience in design, manufacturing, quality assurance or quality engineering position (medical device experience preferred)
- Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development, and manufacturing. Statistical Quality Control/Statistical Process Control
- Design Of Experiments, Failure Mode and Effects Analysis. Experience in a regulated environment (FDA ISO, etc.)
- ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)
- Good communication skills, both written and oral, and must be computer literate
- Blueprint and specification reading. Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development, and manufacturing
- Geometric Dimension and Tolerance activities
- Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485 and 14971 requirements
7
Senior Software Design Quality Engineer Resume Examples & Samples
- 5+ years of software design quality / compliance engineering experience or equivalent
- 2+ years of experience in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and knowledge of how these are applied in the software development lifecycle
- Demonstrated understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products
- Strong verbal (including presentation) and written communication skills
- Understanding of Object Oriented programming techniques (OOP)
- Strong familiarity with regulatory requirements (e.g. ISO 62304, ISO 13485, 21 CFR Part 11, 21 CFR 820, ISO 14971)
- Experience in risk evaluation techniques, such as Product Risk Assessment, FMEA & fault tree analysis
- Familiar with reliability analysis and test methods, including HALT and HASS
- Medical device experience a plus
8
Principal Software Design Quality Engineer Resume Examples & Samples
- Quality System Compliance - Demonstrates complete understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to Division and Corporate policies and procedures. Implements and maintains effectiveness of ADD's Quality System; including the Subsystems and Key processes that govern the area by identifying compliance risks
- Risk Management - Defines the business results expected from risk management strategies and projects. Leads ADD in determining the changes; improvements; and investments needed to support the Risk Management process in the Quality System and business driven objectives. Makes independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Reviews and approves Risk management documentation
- Complaint Evaluation - Investigates complex complaints and carries out tasks with management guidance. Provides overall direction. Ensures compliant documentation in cross-functional areas of support
- Design Control / Documentation & Change Control - Demonstrates a strong working knowledge of the potential global impact of changes including safety and efficacy. Acts as Process Owner and represents the site as an SME or Process Community Member. Negotiates complex changes. Identifies key processes that may be impacted as a result of the change. Effectively reviews and discusses changes with key stakeholders
- Quality Engineering - Draws conclusions reflecting broad business and quality needs. Champions new initiatives and acts as the catalyst for change within and potentially across divisions. Negotiates complex quality decisions. Participates as SME in audits. Acts as a consultant at site and Division or in partnership with supplier for developing quality related strategies for major projects
- Validation - Acts as site SME in audits for all aspects of validation (minimum 2 subsections). Acts as a consultant at site and Division or in partnership with supplier for developing validation strategies for major projects
- Receives little detailed or general direction
- Responsible for ensuring compliant documentation in cross-functional areas of support
- Carries out tasks with management guidance; typically is responsible for decision making
- Decisions have long term impact; aligned with the organization strategy
- At least 8 years work experience in Quality or related filed experience; Less experience may be appropriate with advanced degree
- Has experience in the health care industry
- Has experience working with software development teams
- Has a history of completing successful cross-functional projects and driving positive compliance outcomes
9
Design Quality Engineer Resume Examples & Samples
- Defines, develops and implements Quality Engineering strategies, which contribute to the campus strategic directions. Provides regular updates to Quality Engineering Manager on the execution of the strategy
- Executes the site Quality Management System including CAPA, Internal/External audits, Management Review, Calibration, Maintenance, Training and other aspects to support and maintain certification of ISO 9001 as well as other certifications
- Develops and maintains appropriate systems for document control and storage, access and review pertaining to Quality Systems and project records
- Executes the Global CAPA program to meet or exceed Global and site quality objectives
- Performs suitable Root Cause Analysis using methods including 3-Way 5-Why analysis to determine root cause(s) of internal and external issues and nonconformities
- Execute activities to support the site Quality Objectives
- Develops and maintains QA plans and timeliness of global new product introductions utilizing Advanced Quality Planning and Process Optimization specific to the customer
- Actively contributes to Process efficiency initiatives
- Participates in Procedure reviews with input related to efficiency, content and format
- Oversees and reviews project design process to ensure compliance to internal procedures, customer requirements and regulatory standards
- Drives product quality within the Design Engineering project team through assurance of compliance to Design Controls including Requirements management/verification, Design Inputs, Design Outputs, Design Reviews Design Transfer and Change Management
- Reviews product requirements to ensure clarity, completeness, and to eliminate ambiguity
- Drives Quality System for product development (Product Life Cycle Quality) for assigned projects. Ensures compliance and provides guidance to engineering teams
- Assesses product risk and recommends mitigation actions including DFx, reliability, customer collaboration and others to minimize risk
- Execute the design transfer to the customer upon completion of the project
- BS, Engineering or equivalent
- 6+ Years of related Engineering experience, 4-6 with Masters Degree
- Knowledge of ISO 9001
10
Design Quality Engineer Resume Examples & Samples
- Redesign existing products to address Quality issues while aggressively keeping costs down
- Manage projects cross-functionally from conception through implementation, ensuring timing, quality, and cost targets are met
- Analyze failures to understand the root cause and identify solutions
- Analyze parts to determine conformance to engineering specifications
- Perform tolerance chain analysis to ensure proper engineering specifications on drawings
- Lead and participate in collaborative DFMEA and PFMEA development
- Obtain, process, and analyze field data to identify Quality issues that need to be addressed
- Perform hands-on testing in the lab when necessary in order to gain a first-hand knowledge of issues
- Collaborate with suppliers on Quality improvements and to ensure parts meet engineering requirements
- Partner with the Quality and Manufacturing teams at the factory in Juarez, Mexico to improve designs and processes
- Ensure that designs conform to agency standards (UL, DOE, CSA, etc)
- Develop test plans with test procedures and timelines to validate new designs
- Create reports which clearly explain and justify projects
- Work with suppliers and our requisition system to obtain prototypes for testing and analysis
- Prepare and deliver engineering documentation (3D Models, Engineering Drawings, ECRs, ECNs, Business Cases, etc)
- Up to 20% travel to the factory in Juarez, Mexico to direct the implementation of new designs and collaborate with the team in the factory on Quality initiatives
- CATIA V5 preferred
- Experience with Product Lifecycle Management (PLM) software
- GD&T or ISO equivalent
- Experience with PPAP process
- Tolerance chain analysis
- Ability to manage multiple projects simultaneously, resolve problems, meet deadlines, and handle fast paced critical work environment
- Home Appliance product knowledge. Experience with washers and dryers is a plus
- Strong written and oral communication skills, especially in Technical writing
- Basic computer skills (MS Office, Email, etc) with a strong background in MS Excel
- Outstanding leadership skills, supplier resources and cross functional teams
- Persuasive, encouraging, and motivating personality
- Ability to speak Spanish is a plus
- Process and result oriented
11
Design Quality Engineer Resume Examples & Samples
- Collects, Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, and design and development of new products for consideration by other members of management team
- Cooperates with other management personnel in formulating and establishing company policies, operating procedures and goals
- Develops initial and subsequent modifications of Design Quality Assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program
- Conducts and participates in management meetings with design department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives
- Responsible for managing customer audits, internal audits, and regulatory/compliance agency audits
- Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures
- Particpates and mananges the Design Site Corrective Action process
- Visits and confers with representatives of material and component vendors to obtain information related to supply quality
- Confers with engineers about quality assurance of new products designed, and manufactured products on market to rectify problems
- Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry
12
Design Quality Engineer Resume Examples & Samples
- Review design validation and verification studies associated with new products
- Manage Risk Management Files- lead risk analysis activities, ensure implementation of risk controls and verification of implementation of risk mitigations
- Work with the Engineering/R&D group to evaluate equipment/software, product and process changes and determine if validation/revalidation/verification is required, or if supporting validations are adequate
- Represent the Quality functional area as part of a cross functional product development team
- Develop and maintain a working knowledge of statistics
- Actively obtain and integrate current product technical knowledge into risk management activities
- Support the creation and management Quality Plan specific to the project
- Support with the creation and implementation of DOU, Quality Agreements
- Support the qualification of new suppliers/service providers
- Review all labeling, SOPs, MPs, RMS and Change Order related to the new product
- Create and/or provide support in creation of Risk Management documents
- Audit DHF
- Work with Product Manager to manage new and current SKUs
- Experience with Design Control
- Experience with 21 CFR 820, ISO 13485
- Experience in software/instrument development and validation
- Working knowledge of valid statistical techniques
- Working knowledge of the technical principles related to in-vitro diagnostic device function
- Attention to detail, including thorough documentation of activities
- Working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part820, EN ISO 13485, EN ISO 14971:2012, CMDR)
- Working knowledge of risk management techniques
- Working knowledge of process validation and design control
- Proficiency with Microsoft Office, Word, Visio and Excel
13
Design Quality Engineer Resume Examples & Samples
- Ability to work effectively in a team environment and build strong working relationships
- Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence. Superior communication skills, both oral and written
- Foster an environment that values a diversity and inclusion
- Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills)
14
Principal Design Quality Engineer Resume Examples & Samples
- Bachelor’s Degree in engineering or technical discipline
- 7+ years’ experience in product development or engineering in the medical device industry
- 5+ years with MS
- Previous experience in Quality or R&D Engineering position with design control and product development experience
- Strong familiarity with regulatory requirements ISO 13485 CFR 820 & EN ISO 14971, IEC 62304
- Preferred Skills/Competencies: Previous experience working in a cross-functional team environment
15
Design Quality Engineer Resume Examples & Samples
- Bachelor Degree-Quality Engineering or related field
- Seven (7) years or more product quality assurance experience in the automotive industry
- Must have knowledge of the automotive regulatory & standards requirements (16.949 & IAFT-16.949 auto standard)
- Knowledge of advanced product quality planning & validation needed
- Must have excellent communication (verbal & written), interpersonal, and analytical skills
- Master's Degree in Quality Assurance or related field is desirable
- Six-Sigma training and/or certification is a plus
- Engineering lab testing experience is a plus
16
Design Quality Engineer Resume Examples & Samples
- Bachelor’s Degree in engineering or related science
- Comprehensive knowledge of FDA 21 CFR 820, ISO 13485 and ISO 14971 standards, and in particular, product design controls, development life cycle, risk assessment, and validation
- ASQ Certified Quality Engineer, Minimum of 5 years quality engineering experience in a regulated industry (IVD, medical device, pharmaceutical), with knowledge of product, process, equipment, environment and software validation
- Experienced in root cause investigation and tools
- Quality auditing and supplier qualification experience helpful
17
New Product Design Quality Engineer Resume Examples & Samples
- Participates in the design of medical devices and components from design initiation through design transfer by representing Quality Assurance in all design and development project teams
- Leads multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis
- Determines necessity of testing and initiates testing of assigned products by preparing test and inspection plans, and, identifying and obtaining required test fixtures and test/inspection instrumentation
- Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations
- May supervise, assign, and coordinate the work of others on projects and assignments as appropriate
- Assists in the maintenance of design history files for assigned projects, adhering to Arthrex design control procedures and performing periodic reviews of design history files to assure timely design transfers
- Supports manufacturing suppliers through audits, corrective and preventive actions, assistance in on-site resolution of quality and process related issues
- Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Upper management
18
Design Quality Engineer Resume Examples & Samples
- Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report)
- DFSS / Lean Green Belt or Black Belt Desirable
- Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards. Desirable
- Travel will be required as part of the job with an estimate of 5-10% travel requirements, this position will be based out of Athlone with potential for world wide interfaces/support required
19
Design Quality Engineer Resume Examples & Samples
- Provide quality systems leadership, oversight, and strategic guidance to drive quality initiatives and develop/improve procedures
- Establish and maintain SDLC and QMS processes and tools
- Establish and maintain software related Quality Management System (QMS) process and procedures
- Assist with post-market defect/complaint handling and investigations, CAPAs and other QMS activities such as audits, training and document control
- Train and mentor teams to the usage of SDLC and QMS in their respective projects and functions
- Ensuring compliance to SDLC and QMS across the business unit
- Act as liaison and work closely with the global quality organization to implement QMS within the business unit and integrate it with the global QMS
- Compile and maintain DHF (Design History File) in a dynamic, Agile/Scrum environment with frequent releases
- Drive software risk management process throughout entire product lifecycle
- Assist with validation efforts performed by internal/external validation personnel
- 5-7 years software quality assurance experience
- Experience with Medical Device Software
- Experience with Agile/Scrum methodology and Scaled Agile Framework in a regulated environment preferred
- Experience with FDA QSR/ISO 13485 QMS, including CAPA, root cause analysis and complaint handling/investigations
- Experience with the application of ISO 14971 risk management
- Understanding of software configuration management and other SDLC principles
- Working knowledge of software validation
- Ability to operate flexibly in fast-paced environment
- Able to deliver quality outputs under minimal supervision
20
Senior Software Design Quality Engineer Resume Examples & Samples
- Bachelor’s degree in quality engineering or other related Engineering discipline
- At least a minimum of ten (10) years’ of experience with design and development of Software and Electronic developments in AS9100 / ISO 9001 environments and with Quality Management Systems standards (AS9100 and ISO 9001)
- Advance knowledge with Microsoft Office application tools: Outlook, Word, Excel, Access, PowerPoint, SharePoint
- Good working knowledge and experience with compliance to RTCA/DO-178 required and experience with DO-254 requirements highly desired
- Understand Mechanical Techniques and Interpret Drawings and Specifications Experience in software development for C, C++, C#, and Visual Basic, including performing code reviews desired
- Must be able to provide guidance and establish quality positions regarding program development compliance issues to program management and engineering personnel
- Experience in developing and analyzing quality performance metrics
- Ability to manage relationships with multiple levels of management
- U.S. Person required due to ITAR restrictions
21
Senior Device Design Quality Engineer Resume Examples & Samples
- 85% Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Partner with and provide oversight of external design/development and manufacturing partners on development activities. Lead design control gap assessments and remediation as required
- 10% Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle
- 5% Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards
- Minimum of a Bachelors Degree in engineering or equivalent technical discipline required, advanced degree preferred
- 6+ years of device and/or combination product development within a medical device or biotech / pharmaceutical organization required, including minimum of 2 in design quality, required
- Experience with statistical and six sigma methods required, and Green/Black Belt preferred
- Experience with sustaining engineering preferred
- Experience with electromechanical device development required
- Ability to travel within the US and internationally 10% required
- Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/ relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
- Performs work under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives
- Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions
22
Design Quality Engineer Resume Examples & Samples
- Required to get an alignment from various functions across the regions on quality improvement initiatives
- Proficient in doing metric based assessment and execution
- Have excellent understanding of the NPI Development Process
- Have familiarity with atleast two NPI Functions such as (FE, BE, Analog, DFT, TE)
- Have clear views on quality aspects such as Quality Assurance, Continuous Improvement, Root Cause Analysis & Aligned Way of Working
- Have metric driven execution approach. Should be able to clearly define and track the objective, its measurement criteria and the end goal
- Be Result Oriented. His/her focus should remain achieving aligned end goal even in case of many distractions
- Be eager to experiment on new thought processes using novel initiatives
23
Design Quality Engineer Resume Examples & Samples
- Provides effective oversight of: the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle
- Can lead quality related problem solving for software
- Independently Produces and completes SW Quality Engineering Documents
- Responsible for performing timely, SW Quality engineering tasks like: Assessing SW Quality plans, assessing software designs and reviewing test and other performance data, analyses market feedback, lead root cause analysis and SW Quality problem solving
- May also provide other SW quality engineering support, including assisting organizational units in leading resolution of SW Quality engineering deficiencies
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues
- Fully qualified managers who have advanced beyond entry level
- Has working knowledge of company products and services
- Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions
- Design for Lean Sigma (DFLS) / Six Sigma / Design for Reliability and Manufacturing (DRM) experience
- Minitab experience
- Strong statistics background
24
Design Quality Engineer Resume Examples & Samples
- Bachelor’s degree in Industrial Engineering or related
- 4+ years’ experience in similar position
- Green belt certificate, statistics
25
Design Quality Engineer Resume Examples & Samples
- Support design control activities for new product development efforts
- Help develop product specifications and design/execute design verification and validation activities
- Develop risk assessment; inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams
- Communicate across all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
- Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification
- A minimum BS degree in Engineering or related technical discipline with a minimum of 2 years of experience in related field is required. A Master’s or other advanced degree is a plus
- Interpersonal skills that foster conflict resolution as it relates to technical situations are required
- Previous experience in a medical device or a healthcare discipline is a preferred
- Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred
- Strong Quality Engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is preferred
- Previous Quality Engineering experience is preferred
- Experience with Blueprint reading/literacy including GD&T is preferred
- Working knowledge of material science and mechanical product knowledge is preferred
- Product development and manufacturing experience is preferred
- Knowledge of process and design excellence tools is strongly preferred. Certification is an asset ( Green or Black Belt)
- Fluency in English is required. Good knowledge of German would be a strong asset
- Proven track record implementing Quality System improvements to meet compliance and overall business goals
- Audit supporting experience is preferred
- Opened minded, multicultural environment experience is preferred
26
Design Quality Engineer Resume Examples & Samples
- To work as an integral part of a QARA team for Thermo Fisher’s Microbiology Division business
- Supporting product development phase activities by training and giving guidance to development team to comply to quality system requirements, applicable standards and regulations
- Reviewing and approving development phase procedures and deliverables (project plans, specifications, risk analysis, verification & validation plans and reports) as the QARA team representative
- Act as Subject Matter Expert (SME) and advisor in area of expertise
- Establish and maintain network of internal and external contacts for project collaboration
- To execute activities in accordance with agreed schedules and budget
- To perform cross-departmental internal and external audits
- Follow, interpret and create written Standard Operating Procedures (SOP’s)
- M.Sc (or equivalent) degree in engineering, automation, software, chemistry, microbiology or related field and preferably 2-4 years of experience of working in in vitro diagnostic industry or other regulated environment, or alternatively
- Bachelors Degree in relevant field with preferably 5 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements
- Experience of quality system requirements to worldwide markets, especially Europe and USA
- Demonstrated understanding of product development lifecycles, traceability, design change and document change control, risk management, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a in vitro diagnostic industry or other regulated environment
- Skill set in conducting discussions with international partners
- Excellent verbal and written communications skills in English
- Critical thinking skills and making contributions to the product development as part of a well-integrated team
- Skills in applying various statistical principles to sample size determination and result assessments
- Attention to detail in setting, conducting, and documenting; records keeping in compliance with company policy and regulatory requirements (e.g.CE-IVD and USA FDA; ISO13485)
- Ability to communicate efficiently with the experts in the other scientific and technical fields, and a willingness to learn new skills
- Ability to reach solution with confidence and integrity
27
Senior Electronics Design Quality Engineer Resume Examples & Samples
- Leading a programme of initiatives to drive improvement in Electronics Design for Quality, Reliability, and Manufacturability
- Evaluate and propose improvement in the robustness of design and design review process, design verification, and the manufacturing release process
- Focused on hardware, the role will have a significant embedded firmware component. Familiarity with the software design process would also be a benefit
- Facilitating Lessons Learned documentation and review of improvement opportunities with Product Development teams. Driving continuous improvement will be an important part of the position
- Lead teams in executing DFMEA and Risk Assessment
- Conduct evaluations, including design of experiments and reliability studies, when necessary, to verify that products and/or processes comply with the requirements of applicable specifications - such as design, marketing, test and quality system requirements; and be able to apply statistical methods to products and processes to monitor trends and contribute to the implementation of continuous improvement programs
- The successful candidate must be hands on and able to investigate and support investigation into in-house and field failures for root causes, requesting corrective action where appropriate from the responsible functions or departments,
- Represents the QA department on project and other cross-functional teams as assigned
- Bachelor's degree in Electronics Engineering plus a minimum of 8 year experience ideally in electronics
- Must have a background in Electronics design Or design Quality background
- Must have a working knowledge of the ISO 9000/TS16949/ISO13485 Standards and be capable of developing and auditing procedures that comply with the Standards
- Familiar with quality processes and tools such as APQP, Control Plans, MSA, FMEA etc
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Design Quality Engineer Resume Examples & Samples
- Technical background (engineering degree preferred)
- Software verification and validation experience
- Experience creating DHF and DMR documentation
- Experience creating product inputs and outputs documentation
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Principal Hardware Design Quality Engineer Resume Examples & Samples
- Bachelor's degree in quality engineering, mechanical engineering, electrical engineering or related degree
- Familiarity with EN ISO 60601-1, EN ISO 60601-1- 8, EN ISO 80601-2- 12 a distinct advantage
- Material Analysis, Design of Experiments & Reliability Analysis
- Good verbal and written communication skills including protocol / report development and technical presentations
- Master's degree in quality engineering, mechanical engineering, electrical engineering or related degree
- Familiar with statistical software tools (Minitab, Stat Graphics, Statistic),
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Principal Design Quality Engineer Resume Examples & Samples
- Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements
- Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support the market needs
- Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report)
- Utilize Statistics stools experience such (e.g. Minitab)
- Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
- Assist, when appropriate with internal and supplier audits
- Support the Regulatory Department in writing technical submissions
- Other duties as assigned with or without accommodation
- Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, FMEA & fault tree analysis
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Principal Software Design Quality Engineer Resume Examples & Samples
- Review all project / program software work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports)
- Collaborate with project / program teams to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance
- Plans, develops and implements validation plans for new product development in conjunction with R&D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups
- Generates documentation at the project level, including software and system risk assessment (risk analysis), and requirements compliance matrix (ERM)
- Assist in the analysis of field returns and in-process non-conformities
- Perform CAPA projects and activities
- Participate in technical design reviews (Software), Project phase reviews; CCB (Change Control Board) reviews, post market trend reviews
- Apply and improve advanced technical principles, theories, and concepts in the monitoring and coordination of various design, development, testing, and quality activities
- Utilize knowledge of embedded systems and application software
- Utilize knowledge of various Software Development Life cycle (SDLC) models (e.g. waterfall, spiral / iterative, scrum)
- Utilize knowledge of risk management (generation of software and system risk analysis), CAPA, and/or Design Controls
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases
- Lead and/or participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, SWFMEA, FTA, and risk management report)
- Create and/or assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance
- Provide guidance and direction for sample size and statistical analysis of verification and validation test results
- Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues
- Adheres to the competencies and skills for the specified position as defined in the Quality Professional Leveling Matrix
- Bachelor of Science degree in Software Engineering, Computer Science, Computer Engineering or Electrical Engineering
- 10+ years’ experience with software quality assurance
- 8+ years’ experience in the medical device industry
- Strong familiarity with regulatory requirements ISO 13485,CFR 820 & EN ISO 14971, IEC 62304
- Risk Management, ISO 14971, FTA, FMEA, HACCP
- Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA
- Master's degree in Software Engineering, Computer Science, Computer Engineering or Electrical Engineering
- Previous experience working in a cross-functional team environment
- Familiar with DMAIC or DMADV(DFSS) methodologies
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Design Quality Engineer Resume Examples & Samples
- Thorough knowledge of the market, the industry and the product
- Drive and knowledge to lead product definition
- High level of internal and external networking capabilities
- Customer relationship skills
- Communication & leadership skills, able to work in a matrix organisation
- Fluent in English, French is a plus
- Relevant software skills
- Strong communication skills: verbal, written and visual
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Principal Design Quality Engineer, Software Resume Examples & Samples
- Assume a Subject Matter Expert (SME) on Product Software development process activities and related workflows in relation to regulatory compliance, provide ‘solution-based’ problem resolution
- Act as Quality specialist in relation to software design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate ISO 62304, ISO 62366, ISO 14971 and ISO 13485
- Provide interpretation and guidance on industry best practice Software Development Life Cycle (SDLC) methodologies - mentor/train personnel involved in software development in respective to “Best Practices”
- Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal Waters policies and procedures are met
- Provide leadership and direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance and product performance
- Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product software development (planning, requirements, architecture, verification/validation etc.) including software risk management, maintenance, configuration management and problem resolution
- Minimum of Bachelors Degree. Preferably within Computer Science, systems engineering or related Engineering fields of study
- Minimum 7 years experience supporting quality assurance activities within software development. Preferably within regulated industries
- Desired - Extensive experience in new product development focused on software / quality engineering related activities in a medical device environment
- Desired - Experience of leading quality assurance activities supporting software development in a medical device environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820
- Strong working knowledge of various Software Development Life Cycle (SDLC) models within a complex hardware-software development environment
- Extensive knowledge of and use a variety of software risk management tools, design and process control activities, usability and validation testing methodologies to drive software product quality for new product development in a ISO 9001 environment
- Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality, wants to provide “added value”
- Strong leadership, coaching and mentoring skills
- Exceptional interpersonal and communication skills. Excellent attention to detail. Ability to work on one’s own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills
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Senior Device Design Quality Engineer Resume Examples & Samples
- 85%: Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Partner with and provide oversight of external design/development and manufacturing partners on development activities. Lead design control gap assessments and remediation as required
- 10%: Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle.5%: Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards
- Minimum of a BS in engineering or equivalent technical discipline required, and advanced degree preferred
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Design Quality Engineer Resume Examples & Samples
- Support design guideline implementation
- Support Interface matrix and Validation matrix implementation
- Moderate Risk Assessments related to non-conformances
- Facilitate/Coordinate root cause analyses and support corrective action defining
- Support case owners in Containment & retrofit process
- M.Sc. degree in mechanical engineering or relevant
- Good knowledge in quality tools, methods and systems
- Proven ability to coordinate and lead actions
- Good problem solving skills using logic and fact based decision making
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Design Quality Engineer Resume Examples & Samples
- A minimum of 2 years of experience
- Control plan knowledge
- AMEF (modo efecto de falla) knowledge
- DOE (Design of experiments) knowledge
- Corrective actions Methodology knowledge
- Experience with NPI quality
- Automotive, aerospace, metal mechanic, or alike methodologies
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Design Quality Engineer Resume Examples & Samples
- Proven Quality experience operating in EN9100, EN9110, TickIT Plus, EASA
- Professional conduct and good communication skills to influence both
- Determination and generation of Quality plans to meet Customer requirements
- Ensure Quality Management System adherence to EN9100, EASA Part 21(G) and Part 145, and with customer approvals throughout the Product Development Lifecycle
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Design Quality Engineer Resume Examples & Samples
- As an interface between quality, development and process design you accompany the development of medical implants and instruments by ensuring the accurateness of the applicable quality-related structures and regulations
- In close cooperation with the process owners for design control, who are located across sites, you ensure that all processes meet the international requirements and all necessary approval methods along with all documentation standards are established
- You analyze and supervise the compliance of procedures by verifying development records, design transfer protocols, validation reports and risk analyes and initiate corrective actions as necessary
- The introduction and monitoring of quality key data across sites regarding design control and risk management are part of your area of responsibility as well as independent creation and processing of reports and evaluations in order to encourage and support continuous improvement activities
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Senior Reliability Design Quality Engineer Resume Examples & Samples
- 5+ years of previous experience in a reliability engineer position with B.S./B.A
- 3+ years of previous experience in a reliability engineer position with M.S./M.A
- 0+ years of previous experience in a reliability engineer position with Ph.D
- Previous experience in managing multiple projects having multiple tasks
- Facilitate standardized process for trending, risk assessment, and statistical analysis
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Associate Design Quality Engineer Resume Examples & Samples
- Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 62304, and 14971 requirements
- Knowledge of the software development process for medical devices including Software Verification and Validation
- Thoroughly versed in functional and structural software test, including techniques such as-Unit tests, Integration tests, Code inspection and static analysis, Automated test tools and Traceability and coverage documentation
- Experience integrating hardware and software, particularly in an embedded context
- Strong knowledge of C required (C++ preferred)
- Nice to Have
- An understanding of software programming/validation, and/or design for reliability/six sigma is preferred
- Experience with robotics, controls, dynamics, kinematics, or motion control systems is strongly preferred
