Boston Scientific is seeking a Principal Design Quality Engineer to support the development of its WATCHMAN product. The successful candidate will lead a team of engineers and technicians to apply design controls during product development. The role is based in Maple Grove, MN, and requires at least three days per week on-site. Relocation assistance is available.
Requirements
- In-depth understanding and application of Design Control and Risk Management concepts
- Provide quality and compliance input to project teams
- 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
- Support regulatory submissions to notified bodies
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Relocation Assistance
