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

Insulet

Acton, MA, US
Base: $87,300.00 - $130,950.00; bonus/equity: may ...
Hybrid
Embedded software systems expertise
Design controls compliance
Medical device regulatory knowledge
The Senior Design Assurance Engineer is responsible for ensuring that Insulet’s medical device products meet quality, safety and regulatory requirements throughout the development lifecycle

Job Summary

  • The Senior Design Assurance Engineer is responsible for ensuring that Insulet’s medical device products meet quality, safety and regulatory requirements throughout the development lifecycle.
  • 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 supports end-to-end development of Embedded Software Systems and provides expert guidance on design documentation, verification, and compliance with industry standards.

Matching Summary

The Senior Design Assurance Engineer is responsible for ensuring that 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: May be eligible for incentive compensation; Benefits: Medical, dental, vision insurance, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • Embedded software systems expertise
  • Design Controls compliance
  • Medical device regulatory knowledge
  • Cross-functional team collaboration
  • Software Development Life Cycle adherence
  • Risk management activities
  • Quality Management System experience

Nice-to-have

  • Effective verbal and written communication
  • Project timeline prioritization
  • Analytical and problem-solving skills
  • Ability to work in high-stress environment
  • Master’s degree preferred
  • Quality certification preferred

Key Requirements

  • BS degree in relevant engineering or science field
  • 5-7 years experience in Design Assurance within regulated environments
  • Experience with FDA 21 CFR Part 820 and ISO 13485
  • Knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601
  • Experience working under a Quality Management System
  • ASQ or CQE certification preferred

Work Rights

Not specified

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