Boston Scientific Principal Design Assurance Engineer 

United States, Minnesota, Maple Grove 

453939361

About the role:

Design Assurance Principal 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.

Your responsibilities will include:

• Leads 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

What we're looking for in you:

Required qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline
• 7+ 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.

Preferred qualifications:

• 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

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.