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

Insulet

Acton, MA, US
Base: $127,500.00 - $191,250.00; bonus/equity: eli...
Hybrid
Design control process ownership
Risk management process expertise
Regulatory compliance (21 cfr 820.30, iso 13485)
The Staff Systems Engineer is responsible for enterprise ownership of Insulet’s Design Control process series across the full product lifecycle, ensuring processes remain integrated, compliant, scalable, and audit ready

Job Summary

  • The Staff Systems Engineer is responsible for enterprise ownership of Insulet’s Design Control process series across the full product lifecycle, ensuring processes remain integrated, compliant, scalable, and audit ready.
  • This position offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and employee wellness programs.
  • The role requires partnering closely with multiple departments and senior leadership to drive process alignment, training, and continuous improvement in a hybrid work environment.

Matching Summary

The Staff Systems Engineer is responsible for enterprise ownership of Insulet’s Design Control process series across the full product lifecycle, ensuring processes remain integrated, compliant, scalable, and audit ready.

Salary

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

Skills & Requirements

Must-have

  • Design Control process ownership
  • Risk Management process expertise
  • Regulatory compliance (21 CFR 820.30, ISO 13485)
  • Audit leadership and regulatory support
  • Cross functional collaboration
  • Process harmonization and standardization
  • Systems engineering mindset

Nice-to-have

  • Experience with PLM/eQMS/ALM tools
  • Process focused training and coaching
  • Global matrixed environment experience
  • Familiarity with risk management tools
  • Presentation skills to senior leadership
  • Process transformation initiatives
  • Knowledge of multiple product lifecycle models

Key Requirements

  • Bachelor’s degree in relevant technical field
  • 10+ years medical device development experience
  • Deep knowledge of Design Controls and Risk Management
  • Experience as process owner or SME for regulated processes
  • Strong audit support experience
  • Master’s degree preferred

Work Rights

Not specified

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