Design Quality Assurance Engineer II

4 weeks ago

Arden Hills, Minnesota, United States Boston Scientific Full time
About the Role:

The Design Quality Assurance Engineer II is a quality engineer who directly supports medical device product development and commercialized product design changes. This engineer will work with a high-performing cross-functional team to ensure safety, quality, and compliance of the launched products while continuously improving their commercial value.

This high visibility position in Cardiac Rhythm Management (CRM) division provides the right candidate with excellent growth potential. The responsibilities of this role include:
  • Acting as an effective team member in supporting quality disciplines, decisions, and practices
  • Working within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
  • Actively participating in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
  • Demonstrating good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards
  • Supporting the verification, validation, and usability testing to meet or exceed internal and external requirements
  • Learning, using, and teaching the most effective engineering tools to optimize designs of cardiac rhythm management (CRM) systems
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Serving as an effective quality leader or team member on a cross-functional product development team
  • Owning and driving deliverables related to Design Controls, Product Performance, Quality, and Compliance
  • Reviewing and approving quality records, including product specifications, design verification test protocols, design verification test reports
  • Partnering cross-functionally to identify and support value improvement efforts to support business goals
  • Supporting internal and external audit activities

What We're Looking For:

We're looking for a highly skilled and experienced quality engineer who can join our team and contribute to the development and commercialization of medical devices. The ideal candidate will have a strong background in quality assurance, design controls, and regulatory compliance, as well as excellent communication and collaboration skills. If you're a motivated and detail-oriented individual who is passionate about quality and safety, we encourage you to apply for this exciting opportunity.

Boston Scientific is a global leader in medical science, and we're committed to advancing science for life. Our mission is to improve patient lives, create value for our customers, and support our employees and the communities in which we operate. We're proud to be an equal opportunity employer and welcome applications from diverse candidates.

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