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Senior 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: 
We have an exciting opportunity for a Senior Design Quality (or Design Assurance) Engineer supporting percutaneous coronary intervention (PCI) single use devices (SUD) within the Interventional Cardiology (IC) division.  This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and product development experience.  This role will apply the directives of design controls supporting product development, design changes, regulatory and standards compliance, corrective and preventive actions, identifying improvements for manufacturability and cost-reduction efforts. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Your responsibilities include: 

  • Support the execution and documentation of Design Validation & Verification and Usability activities.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. 
  • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
  • Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
  • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Lead and support cross-functional root-cause analysis investigation and resolution activities
  • Evaluate and support design test and inspection method development, and lead method validation activities
  • Support regulatory submissions to notified bodies.
  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we’re looking for:
Required Qualifications

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field of study 
  • 5+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience 
  • Problem solver, capable of facilitating the problem-solving process 
  • Adaptable and effective collaborator in a team environment and in self-directed work
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies

Preferred Qualifications

  • Ability to work in a highly matrixed and geographically diverse business environment

Requisition ID: 585549

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

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, Compliance, Medical Device Engineer, Mechanical Engineer, Design Engineer, Engineering, Legal

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