Boston Scientific is seeking a Design Quality Principal Engineer to support the development of single-use devices for medical electrical equipment/systems within their Interventional Cardiology division. This role is crucial for ensuring the quality and compliance of next-generation medical devices, addressing challenges in the health industry, and driving product development.
Requirements
- ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use
- Minimum of 8 years experience in design assurance, quality, or related medical device or regulated industry experience
- Experience with Class III Medical Devices
- Focus on detailed work with emphasis on accuracy and completeness
- Problem solver, capable of facilitating the problem-solving process & driving issues to closure
Responsibilities
- Responsible for design control and risk management of next-generation medical devices
- Uses clinical knowledge to influence how devices are tested and designed
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
- Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
- Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
- Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).
Other
- Bachelor’s degree in engineering or science discipline, or equivalent.
- Strong communication skills (verbal & written) and presentation skills
- Excellent organizational and planning skills; drives for results
- Travel approximately <10%
- Ability to collaborate and work on a highly matrixed and global team
