Boston Scientific is looking to solve challenges in the health industry by developing and commercializing medical devices, specifically supporting the WATCHMAN projects within the Cardiology division. The Design Quality Assurance Engineer III will ensure the safety, quality, and compliance of these products throughout their lifecycle.
Requirements
- ISO 13485, ISO 14971, and Quality System Regulations understanding
Responsibilities
- Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements
- Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
- Support regulatory submissions to notified bodies.
- Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
- Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation
- Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.
Other
- Minimum of a Bachelors Degree in Engineering, or equivalent.
- Minimum of 3 years of experience in design assurance, quality, product development or related medical device or regulated industry experience
- Self-motivated with a passion for solving problems and a bias for action.
- Strong communication skills (verbal & written) and presentation skills
- Focus on detailed work with emphasis on accuracy and completeness
- Excellent organizational and planning skills; drives for results
- High energy problem solver capable of driving items to closure
