Staff Software Test Engineer

Abbott

Alameda, CA, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
Fda 21 cfr 820 compliance experience
Iso 13485 and iec 62304 standards
Medical device v&v and defect management
This role is critical for ensuring product quality, regulatory compliance, and scalable delivery within Abbott's Lingo health platform

Job Summary

  • This role is critical for ensuring product quality, regulatory compliance, and scalable delivery within Abbott's Lingo health platform.
  • The position requires translating technical requirements into comprehensive verification strategies that adhere to strict FDA and ISO standards.
  • Employees benefit from free medical coverage, a high employer contribution retirement plan, and extensive tuition reimbursement programs.

Matching Summary

This role is critical for ensuring product quality, regulatory compliance, and scalable delivery within Abbott's Lingo health platform.

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • FDA 21 CFR 820 compliance experience
  • ISO 13485 and IEC 62304 standards
  • Medical device V&V and defect management
  • CI/CD ecosystem integration skills
  • End-to-end software verification execution

Nice-to-have

  • Automation-first mindset approach
  • Python or JavaScript proficiency
  • Cloud-native architecture knowledge
  • Mentoring junior engineers capability
  • System integration testing experience

Key Requirements

  • Bachelor's degree in software engineering or equivalent
  • 10+ years of software verification experience
  • 3+ years in medical device software development
  • Experience with FDA 21 CFR 820 regulations

Work Rights

Not specified

Tailored Resume

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