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

Insulet Corporation

San Diego, CA, US
Base: $117,700.00 - $176,500.00; bonus/equity: eli...
Hybrid
8+ years design quality assurance experience
Knowledge of fda 21 cfr part 820 regulations
Experience with iso 13485 and iso 14971 standards
The role leads Quality Assurance activities for partner-integrated software products including connected hardware and mobile applications

Job Summary

  • The role leads Quality Assurance activities for partner-integrated software products including connected hardware and mobile applications.
  • Candidates must ensure shared compliance with global regulations such as FDA, ISO 13485, and IEC 62304 for Class II and III devices.
  • The position offers a comprehensive benefits package including medical insurance, 401(k) match, and paid time off.

Matching Summary

The role leads Quality Assurance activities for partner-integrated software products including connected hardware and mobile applications.

Salary

Base: $117,700.00 - $176,500.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision, 401(k) match, PTO

Skills & Requirements

Must-have

  • 8+ years design quality assurance experience
  • Knowledge of FDA 21 CFR Part 820 regulations
  • Experience with ISO 13485 and ISO 14971 standards
  • Expertise in IEC 62304/82304 software lifecycle
  • Understanding of Class II and III medical devices

Nice-to-have

  • ASQ or CSQE certification preferred
  • Familiarity with AI/ML validation processes
  • Strong analytical and problem-solving skills
  • Experience with agile development environments
  • Excellent verbal and written communication skills

Key Requirements

  • Bachelor's degree in Engineering or Computer Science
  • Master's degree preferred
  • 8+ years in medical device design quality assurance
  • Working knowledge of cybersecurity and risk management
  • Hybrid work arrangement eligibility required

Work Rights

Not specified

Tailored Resume

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