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Principal Quality Engineer Job

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Date: Nov 23, 2021

Location: Arden Hills, MN, United States, 55112

Company: Boston Scientific


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.


Principal Quality Engineer

About this role:
The Principal Quality Engineer will serve on a high-performing, cross-functional product development team to design world class Cardiac Rhythm Management (CRM) Systems.  You will lead the safety risk engineering activity including Hazard Analysis, Fault Tree Analysis, and Design Failure Modes and Effects Analysis (DFMEA).  This high visibility position provides the right candidate with excellent growth potential.  

Your responsibilities will include:

  • Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
  • Highly cross-functional in nature, this role consults with product experts, design engineering, post market quality, and medical safety functions for risk analysis across the life of Boston Scientific CRM products
  • May provide support to Design Quality Engineers on new product development and sustaining engineering projects

What we’re looking for in you:
Minimum Qualifications:

  • BS degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline
  • 9+ years of experience in safety risk engineering, design assurance, post-market quality, or design engineering
  • Experience developing complex, high-reliability systems in a regulated industry, including medical devices, pharmaceuticals, or aerospace.
  • Strong mechanical, electrical, software, or systems aptitude 
  • Team player with a record of success in positions of increasing responsibility in a fast paced, dynamic environment
  • Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics 
  • Superior communication and analytical skills
  • Familiarity with risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, DFMEA, and Corrective and Preventive Actions (CAPA) 

Preferred Qualifications:

  • Direct experience in risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
  • Experience developing Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD)
  • Experience with XML language and MED-8 DFMEA software
  • Experience using quality tools and methodologies for design optimization including DFMEA, Design of Experiments (DOE), Finite Element Analysis (FEA), Brainstorming, Root Cause Analysis, Ishikawa diagram, 5 Why’s
  • Understanding of regulations applicable to medical device design controls and risk management, including FDA 21 CFR 820, ISO 13485, EN ISO 14971, MDD, AIMD, and EU MDR
  • Professional Certifications, including American Society for Quality Certified Quality Engineer



Requisition ID: 513497


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 drug-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.


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