Senior Quality Engineer

Medtronic Inc. Boulder , CO 80301

Posted 1 week ago

Bring your talents to an industry leader in medical technology and healthcare solutions we're a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

Join us for a career in IT that changes lives.

Careers that Change Lives

A Day in the Life

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:

  • Provide quality engineering support for commercialized finished devices and device systems. Conduct analysis of existing products' documented compliance and supporting evidence to maintain State of the Art conformance to applicable regulatory and quality standards.

  • Ensure ongoing conformance for on-market products, including planned mitigations in anticipation of scheduled changes to regulatory and standards requirements.

  • Assure products meet regulatory requirements including FDA Quality System Regulations 21CFR Part 820, Medical Device Directive (MDD) 93/42/EEC, Canada Medical Devices Regulations (CMDR) (SOR/98-282) and internal Medtronic procedures.

  • Apply knowledge of ISO 14971 Risk Management; IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle; and other applicable standards to sustaining engineering projects.

  • Serve as primary quality representative on one or more project teams engaged in sustaining engineering projects to plan, execute, verify and document commercialized product remediation, including supplemental testing and/or design change.

  • Ensure risk management documentation is updated in coordination with remediation activities, and interfacing with project team members including engineering, regulatory, marketing, and production.

  • Produce technical reports to support product changes or quality assurance investigations.

  • Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.

  • Makes decisions and proposes solutions based on calculated risks identified through data analysis.

  • Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

  • Devises and implements methods and procedures for inspecting, testing and evaluating the durability, precision and accuracy of products and production equipment.

  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

  • The ideal candidate is a seasoned individual contributor who works independently under limited supervision to determine and develop approach to solutions. May be responsible for entire projects or processes within assigned areas.

  • Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.

  • Makes improvements of processes, systems or products to enhance performance of the job area.

  • Analysis provided is in-depth in nature and often provides recommendations on process improvements.

  • Communication and Influence: Communicates with senior internal and external customers and vendors.

  • Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

  • May provide guidance, coaching and training to other employees within job area.

  • May manage projects, requiring delegation of work and review of others' work product

Nice to Have:

  • ASQ certification

  • Effective verbal and written communication, analytical, influencing and interpersonal skills.

  • Must be able to effectively communicate at all levels and across company lines.

  • Six-Sigma (or equivalent) greenbelt certification

  • Experience working in a team environment

  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, ISO 14971, ISO 13485 and JPAL

  • May have practical knowledge of project management.

MUST HAVE: MINIMUM REQUIREMENTS:

EDUCATION REQUIRED:

  • Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A)

YEARS OF EXPERIENCE:

  • Minimum of 4 years of relevant experience with a Bachelors Degree

  • Minimum of 2 years relevant experience with an advanced degree

SPECIALIZED SKILLS OR EXPERIENCE:

  • Requires advanced knowledge of Quality Engineering tools and skill-sets combining breadth and depth, typically obtained through advanced education combined with experience.

NICE TO HAVE

  • ASQ certification

  • Effective verbal and written communication, analytical, influencing and interpersonal skills.

  • Must be able to effectively communicate at all levels and across company lines.

  • Six-Sigma (or equivalent) greenbelt certification

  • Experience working in a team environment

  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, ISO 14971, ISO 13485 and JPAL

  • May have practical knowledge of project management.

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Senior Quality Engineer

Medtronic Inc.