Senior Software Requirements & Systems Engineer (medical Devices) (hybrid - Acton, Ma Or San Diego, Ca)

Insulet

Acton, MA, US
Base: $102,400.00 - $153,550.00; bonus/equity: may...
Hybrid
Software requirements management
Regulated medical device environment
Requirements traceability per iec 62304
Lead the creation, analysis, and governance of software requirements for Insulet's next-gen wearable medical device, spanning mobile and cloud

Job Summary

  • Lead the creation, analysis, and governance of software requirements for Insulet's next-gen wearable medical device, spanning mobile and cloud.
  • This position offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and employee wellness programs.
  • This role supports hybrid working arrangements requiring on-site presence at least once per week with remote work flexibility.

Matching Summary

Lead the creation, analysis, and governance of software requirements for Insulet's next-gen wearable medical device, spanning mobile and cloud.

Salary

Base: $102,400.00 - $153,550.00; Bonus/Equity: May be eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • software requirements management
  • regulated medical device environment
  • requirements traceability per IEC 62304
  • ALM/PLM tools experience
  • cross-functional stakeholder facilitation
  • Agile environment alignment

Nice-to-have

  • medical device standards knowledge
  • systems engineering certifications
  • diabetes management product familiarity
  • mobile and cloud technology experience
  • PLM change control experience
  • cybersecurity and privacy knowledge

Key Requirements

  • 5+ years in safety-critical or regulated products
  • experience with software/system requirements
  • knowledge of systems engineering practices
  • working knowledge of ALM tools
  • Bachelor’s degree or equivalent experience

Work Rights

Not specified

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