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Principal Design Assurance Engineer

Work mode:  Hybrid
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Locations:  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:
The Principal Design Assurance Engineer is a quality engineer who directly supports medical device product development from concept through commercialization.  This engineer will serve on a high-performing cross-functional product development team to design world class Cardiac Rhythm Management Systems that drive corporate growth.  This high visibility position provides the right candidate with excellent growth potential.

Your responsibilities will include:

  • Learn, use, and teach the most effective engineering tools to optimize designs of cardiac rhythm management (CRM) systems – Design Failure Modes and Effects Analysis (DFMEA), Benchmarking, Design of Experiments (DOE), Highly Accelerated Life Testing (HALT), Tolerance Stack Up Analysis, Engineering Statistics, and Weibull Analysis. This position is a technical, engineering job.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Serve as an effective quality leader or team member on a cross-functional product development team.
  • Owns and drives deliverables related to Design Controls, Product Performance, Quality, and Compliance. 
  • Develops and implements quality strategies; seeks innovative approaches to attain quality goals.
  • Review and approve quality records, including product specifications, design verification test protocols, design verification test reports. 
  • Maintains and enhances cross-functional team relationships. 
  • Directly interfaces with internal and external audit activities. 

Minimum qualifications:

  • Bachelor’s degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline
  • 6 years of experience in design assurance, post-market quality, or R&D engineering 
  • Strong mechanical and electrical aptitude
  • Experience writing specifications, test protocols, and technical reports
  • Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, 5 Why’s. 
  • Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics
  • Experience with mechanical and electrical test and measurement equipment

Preferred qualifications:

  • Bachelor’s degree and 9+ years or Master's degree with 6+ years of experience in design assurance, post-market quality, or R&D engineering
  • Experience in design engineering or process development, including design optimization, process validation, and continuation engineering,
  • Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA)
  • Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization
  • Experience with Active Implantable Medical Devices
  • Adaptable and effective collaborator in a team environment or in self-directed work



Requisition ID: 572949


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!

Nearest Major Market: Minneapolis

Job Segment: Test Engineer, Medical Device, Biomedical Engineering, Testing, Medical Device Engineer, Engineering, Healthcare, Technology

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