Staff Systems Engineer - Design Control & Risk Management Process Owner (hybrid - Acton, Ma Or San Diego, Ca)

Insulet Corporation

Acton, Massachusetts, United States
Base: $127,500.00 - $191,250.00 annually; bonus/eq...
Hybrid
10+ years medical device development experience
Deep knowledge of iso 14971 risk management
Expertise in 21 cfr 820.30 design controls
This strategic role serves as the single point of accountability for the entire Design Control ecosystem across Insulet's evolving portfolio of hardware, software, and cybersecurity technologies

Job Summary

  • This strategic role serves as the single point of accountability for the entire Design Control ecosystem across Insulet's evolving portfolio of hardware, software, and cybersecurity technologies.
  • The position requires deep expertise in maintaining regulatory compliance with ISO 14971 and 21 CFR 820.30 while driving continuous improvement and standardization of enterprise processes.
  • Candidates will benefit from a comprehensive benefits package including medical, dental, vision insurance, 401(k) matching, and paid time off alongside an annual base salary range of $127,500.00 - $191,250.00.

Matching Summary

This strategic role serves as the single point of accountability for the entire Design Control ecosystem across Insulet's evolving portfolio of hardware, software, and cybersecurity technologies.

Salary

Base: $127,500.00 - $191,250.00 annually; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • 10+ years medical device development experience
  • Deep knowledge of ISO 14971 risk management
  • Expertise in 21 CFR 820.30 design controls
  • Experience leading internal and external audits
  • Systems engineering background with QMS focus

Nice-to-have

  • Experience with agile and waterfall lifecycle models
  • Familiarity with Polarion or Helix traceability tools
  • Proven track record in enterprise process harmonization
  • Ability to influence cross-functional teams without authority
  • Experience presenting complex topics to senior leadership

Key Requirements

  • Bachelor's degree required; Master's preferred
  • Minimum 10 years in medical device systems engineering
  • Demonstrated experience as a regulated process owner
  • Strong background in Verification & Validation methodologies

Work Rights

Not specified

Tailored Resume

Cover Letter