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Design Quality Engineer II- WATCHMAN Job

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Date: Nov 25, 2021

Location: Maple Grove, MN, United States, 55311

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.


Design Assurance Engineer II

About the role: 

We have an exciting opportunity for an Engineer supporting WATCHMAN projects within the Interventional Cardiology division.  This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry.  In this position you will work with a cross-functional team to maintain the design control and risk analysis files, analyze product performance, recommend appropriate action, and incorporate design and process improvements for devices currently in commercialization.   

Your responsibilities include: 

  • Analyze post market surveillance information & determine action to reduce complaints/optimize product performance. 
  • Lead NCEP/CAPA activities in a cross-functional teamwork environment.
  • Maintain Risk Management File including Risk Change Analysis, Risk Management Plan/Report, Hazard Analysis, DFMEA, Task Analysis, and connections to PRA/Supplier Controls. 
  • Partner with R&D to determine and maintain Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Coordinate the execution and documentation of Design Validation and Verification activities associated with design change.
  • Generate Design Verification and Validation protocols and reports.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. 
  • Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards. 
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies.
  • Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints). 
  • Mentor cross functional team specifically with respect to NCEP/CAPA, design control, and risk management deliverables.

What we’re looking for:
Minimum requirements:

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study 
  • 2+ years of experience in engineering 
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on approach to problem solving
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies



Requisition ID: 505556


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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