Boston Scientific Design Assurance Engineer II 

United States, Minnesota, Maple Grove 

794898523

Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for ensuring quality and compliance through product development and commercialization.

Your responsibilities will include:

• Participates in the implementation of new product design (NPD) Risk management (per ISO 14971) – Including generation of Hazard Analyses, Design FMEAs, requirements traceability matrices, etc.
• Support verification, validation, and usability testing to meet or exceed internal and external requirements
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Develop Design History File and work with RD for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

What we're looking for in you:

Required qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline
• 2 years of experience in design assurance, new product development, or related medical device or regulated industry experience
• Working knowledge of US and International medical regulations including 21 CFR 820, Medical Device Directive / Medical Device Regulation, EN ISO 13485, and EN ISO 14971

Preferred qualifications:

• Experience with class III medical devices
• Experience with medical standards compliance

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.