Design Assurance Engineer III

Maple Grove, MN

Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Recruiter: Spencer Gregory Hale

Design Assurance Engineer III

About the role:

We have an exciting opportunity for a Design Assurance (DA) Engineer III 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 and new product development experience. In this position you will work with a Design Assurance and cross-functional team to support medical device product development from concept through commercialization and maintain the design control and risk analysis files.

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).
  • 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:

Minimum Qualifications

  • Bachelor’s degree in mechanical engineering, biomedical engineering, or related field of study
  • 3+ 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

Requisition ID: 578566 Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Nearest Major Market: Minneapolis

Job Segment: Biomedical Engineering, Medical Device Engineer, Design Engineer, Compliance, Medical Device, Engineering, Legal, Healthcare

North America

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