Design Quality Engineer II - Interventional Cardiology
About The Position
Boston Scientific is currently recruiting for a Design Quality Engineer II at our Arbor Lakes campus in Maple Grove, MN. This is an exciting opportunity to participate as a design assurance team member in the development of capital equipment products for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC. The Design Quality Engineer II will support the application of design controls and risk management to projects with a focus on new product development. This individual will work within a high performing cross-functional team to ensure safety, quality, and compliance of products.
Requirements
- Bachelor of Science degree in engineering or related field
- 2+ years of experience in an engineering role within medical device or similar regulated industry
- Knowledge of Quality System Requirements, Good Documentation Practices, and relevant standards and regulations (e.g., ISO 13485, ISO 14971)
- Comfortable working independently and as part of a cross-functional team
- Collaborative mindset and willingness to learn in a team-oriented environment
- Strong written and verbal communication skills
Nice To Haves
- Bachelor’s degree in Electrical, Computer, or Biomedical Engineering
- Familiarity with quality tools and methodologies include DFMEA, Hazard Analysis, and Root Cause Analysis
- Demonstrated ability to solve engineering problems using analysis, experimentation, and statistics
- Experience with technical writing, such as specifications, test protocols, and technical reports
Responsibilities
- Develop, update, and maintain Design History File and Design Input / Output documentation (e.g., Product Specification, Component Specifications, and Prints)
- Develop, update, and maintain product Risk Management documentation (e.g., Hazard Analysis, Fault Tree, FMEAs)
- Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements
- Work within a cross-functional team to identify and implement effective controls and support new product and commercial design changes, specifically with regard to quality and risk management
- Apply sound, systematic problem-solving methodologies to resolve quality issues
- Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs
- Apply basic problem-solving techniques to identify, communicate, and resolve quality issues
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
Benefits
- Relocation assistance may be available for this position at this time.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
