Senior Design Quality Engineer
About The Position
Boston Scientific is currently recruiting for a Senior Design Quality Engineer in our Maple Grove, MN location. This is an exciting opportunity to serve as a key Design Assurance representative on cross functional teams supporting sustaining and design change activities for electronic medical equipment (EME) within Boston Scientific's rapidly growing Interventional Cardiology/Vascular division. The Senior Design Quality Engineer provides focused quality engineering leadership on new product development design assurance. Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for ensuring quality and compliance through product development and commercialization. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local Maple Grove office three days per week.
Requirements
- Bachelor's degree in mechanical, electrical, biomedical engineering, or related discipline
- 5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience
- Understanding of electrical safety standards IEC 60601
- Experience with reliability testing
- Demonstrated use of Quality tools/methodologies
- Strong written/verbal communication skills.
Nice To Haves
- Experience with class III medical devices
- BS in Electrical Engineering
- Previous R&D experience
- Strong knowledge of QSR and ISO standards
- Medical device experience
- ASQ certification
Responsibilities
- Lead or mentors the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIR
- Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate
- Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors
- Influences cross-functional plans, guides overall project strategy, knows when to solicit feedback, and facilitate project decisions
- Builds quality into all aspects of work by maintaining compliance to all quality requirements, defending work of their team, as well as supports internal external regulatory audits
- Participates as a division representative in cross-divisional projects defining the quality system and may advise management on potential improvements to the quality systems and processes
- Supports functional and divisional design quality goals and priorities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
Number of Employees
5,001-10,000 employees
