Software Design Assurance Engineer (hybrid - San Diego, Ca)

Insulet

San Diego, CA, US
Base: $77,600.00 - $116,375.00; bonus/equity: may ...
Hybrid
Quality assurance in regulated environment
Compliance with iec 62304 and fda guidance
Design control for fda class ii and iii devices
This position is responsible for driving Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems used as part of the quality system

Job Summary

  • This position is responsible for driving Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems used as part of the quality system.
  • We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) with company match, paid time off (PTO), and additional employee wellness programs.
  • Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.

Matching Summary

This position is responsible for driving Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and automated data processing systems used as part of the quality system.

Salary

Base: $77,600.00 - $116,375.00; Bonus/Equity: May be eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • Quality Assurance in regulated environment
  • Compliance with IEC 62304 and FDA guidance
  • Design Control for FDA Class II and III devices
  • Cybersecurity risk management
  • Software development lifecycle expertise
  • Risk Management per ISO 14971
  • Software validation and verification

Nice-to-have

  • Effective verbal and written communication
  • Collaboration across multiple organizational levels
  • Ability to manage multiple concurrent responsibilities
  • Experience with cloud-based and mobile applications
  • Continuous Improvement initiatives
  • Training delivery for software development teams

Key Requirements

  • BS degree or equivalent experience
  • 2-5 years Quality Assurance experience in FDA or ISO regulated environment
  • Experience with medical device software development
  • Knowledge of FDA 21 CFR Part 820 and ISO 13485
  • Familiarity with IEC 62304, ISO 14971, IEC 62366, IEC 60601
  • ASQ, CSQE or other software quality certificates beneficial

Work Rights

Not specified

Tailored Resume

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