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Principal Design Assurance Engineer

Work mode:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.                

About the role:
Boston Scientific is currently recruiting for a Design Assurance Principal Engineer in our Maple Grove, MN location.  This is an exciting opportunity to participate in development of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.     

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

Requisition ID: 585017

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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.

Nearest Major Market: Minneapolis

Job Segment: Biomedical Engineering, Medical Device, Medical Device Engineer, Electrical Engineering, Compliance, Engineering, Healthcare, Legal

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