Staff Software Dqa Engineer - Partner Management (hybrid - San Diego, Ca)

Insulet

San Diego, CA, US
Base: $117,700.00 - $176,500.00; bonus/equity: may...
Hybrid
Design quality assurance for medical devices
Regulatory compliance with fda and iso standards
Software quality engineering in regulated environments
The Staff Software Design Quality Assurance Engineer is responsible for leading QA and quality engineering activities for new product development and sustaining programs involving integration with Insulet’s partners

Job Summary

  • The Staff Software Design Quality Assurance Engineer is responsible for leading QA and quality engineering activities for new product development and sustaining programs involving integration with Insulet’s partners.
  • This position offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and employee wellness programs.
  • Insulet is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform and is committed to hiring highly motivated, performance-driven individuals.

Matching Summary

The Staff Software Design Quality Assurance Engineer is responsible for leading QA and quality engineering activities for new product development and sustaining programs involving integration with Insulet’s partners.

Salary

Base: $117,700.00 - $176,500.00; Bonus/Equity: May be eligible for incentive compensation; Benefits: Medical, dental, vision insurance, 401(k) with company match, PTO, wellness programs

Skills & Requirements

Must-have

  • Design quality assurance for medical devices
  • Regulatory compliance with FDA and ISO standards
  • Software quality engineering in regulated environments
  • Integration of digital products with partner systems
  • Risk management and quality decision-making
  • Cybersecurity and AI/ML validation for software
  • Cross-functional collaboration in agile environment

Nice-to-have

  • Excellent verbal and written communication skills
  • Ability to manage multiple responsibilities concurrently
  • Strong analytical and problem-solving skills
  • Experience working in high-stress, high-energy environments

Key Requirements

  • Bachelor’s degree in Engineering or related field
  • 8+ years in design quality assurance in medical device industry
  • Experience with Class II and III medical devices
  • Knowledge of FDA 21 CFR Part 820 and ISO 13485
  • Familiarity with IEC 62304/82304, ISO 14971, IEC 62366, IEC 60601
  • Experience with software development tools and quality systems
  • ASQ or CSQE certification beneficial

Work Rights

Not specified

Tailored Resume

Cover Letter