Sr. Sw Dqa Engineer - Embedded Sw (hybrid - Acton, Ma)

Insmed

Acton, MA, US
Base: $87,300.00 - $130,950.00; bonus/equity: elig...
Hybrid
5-7 years design assurance experience
Fda 21 cfr part 820 design controls
Iso 13485 quality system regulation
The Senior Design Assurance Engineer ensures Insulet's medical device products meet quality, safety, and regulatory requirements throughout the development lifecycle

Job Summary

  • The Senior Design Assurance Engineer ensures Insulet's medical device products meet quality, safety, and regulatory requirements throughout the development lifecycle.
  • This role provides expert guidance on creating and reviewing essential technical documentation including Design History File deliverables and traceability matrices.
  • The company offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, and paid time off.

Matching Summary

The Senior Design Assurance Engineer ensures Insulet's medical device products meet quality, safety, and regulatory requirements throughout the development lifecycle.

Salary

Base: $87,300.00 - $130,950.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k), PTO

Skills & Requirements

Must-have

  • 5-7 years Design Assurance experience
  • FDA 21 CFR Part 820 Design Controls
  • ISO 13485 Quality System Regulation
  • IEC 62304 Software Development Life Cycle
  • ISO 14971 Risk Management FMEA
  • Embedded Software Systems knowledge

Nice-to-have

  • Master's degree in relevant field
  • ASQ CQE quality certification
  • Cybersecurity risk-management activities
  • Strong analytical problem-solving skills
  • Experience with real-time operating systems

Key Requirements

  • BS degree in Computer Science or Engineering
  • 5-7 years regulated environment experience
  • Knowledge of IEC 62366 and IEC 60601
  • Hybrid work arrangement eligibility

Work Rights

Not specified

Tailored Resume

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