Design Assurance Engineer III
Location
Maple Grove, MN | United States
Job description
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.
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