Systems Engineer V&v (hybrid - Acton, Ma)

Insulet Corporation

Acton, Massachusetts, United States
Base: $77,300.00 - $116,00.00; bonus/equity: eligi...
Hybrid (requires on-site work from an insulet office at least 2x/week; may work remotely other days)
Verification and validation planning
Medical device testing experience
Requirements analysis and test cases
Insulet Corporation is seeking a Systems Engineer for Verification and Validation (V&V) to join their team in Acton, MA. The role involves managing V&V activities for medical device products, requiring a strong background in engineering and experience in testing within a multidisciplinary environment

Job Summary

  • The Systems Engineer V&V will lead verification and validation activities for new product development and sustaining products within the Medical Devices R&D department.
  • Candidates must manage third-party verification activities to ensure full compliance with standards such as IEC 60601-1 and applicable collateral standards.
  • The role offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, and paid time off.

Matching Summary

Match Score: 85

Insulet Corporation is seeking a Systems Engineer for Verification and Validation (V&V) to join their team in Acton, MA. The role involves managing V&V activities for medical device products, requiring a strong background in engineering and experience in testing within a multidisciplinary environment.

Salary

Base: $77,300.00 - $116,00.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO

Skills & Requirements

Must-have

  • Verification and Validation planning
  • Medical device testing experience
  • Requirements analysis and test cases
  • RQM tools (DOORs, Helix, Jama)
  • IEC/AAMI/UL 60601-1 compliance
  • Hybrid work arrangement in Acton MA

Nice-to-have

  • Atlassian Tools (JIRA, Confluence, Bamboo)
  • System level testing of software devices
  • Test Engineering training or certification
  • FDA regulated Class 2 or 3 devices
  • Cross-functional team leadership skills

Key Requirements

  • Bachelor's degree in Biomedical, Software, Mechanical, Electrical Engineering or related field
  • Minimum 3 years experience testing medical devices
  • Experience working under Design Controls and ISO 13485 standards

Work Rights

Not specified

Tailored Resume

Cover Letter