Design Assurance Engineer III

3 weeks ago

Maple Grove, Minnesota, United States Boston Scientific Full time

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:

The Design Assurance Engineer III is a quality engineer that directly supports medical device product development through the product life cycle from concept through commercialization.This individual will work with a high performance cross-functional team to ensure safety, quality and compliance of the launched products while continuously improving their commercial value. This position will focus on products for the Interventional Oncology and Vascular franchises in the Electronic Medical Equipment (EME) space.

Your responsibilities will include:

  • 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 and execute electrical and software Design Verification (DV) test protocols
  • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
  • 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
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
  • Develop, update, and maintain Design History File (DHF) and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements
  • Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input

What we're looking for in you:

Required Qualifications:

  • Bachelor's degree in Computer Engineering, Electrical Engineering, or other related field of study
  • Minimum of 3 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience

Preferred Qualifications:

  • ISO 13485, ISO 14971 and FDA Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
  • Experience with design changes, complaint reduction, and corrective action
  • Adaptable and effective collaborator in a team environment and in self-directed work
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies
  • Experience with JIRA and software quality

Requisition ID:584190

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 freeworkplace. Pursuant to Va. Code * , 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.



Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

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