Principal Ai Quality Engineer

Leica Biosystems

Vista, CA, US
Base: $160,000 - $180,000; bonus/equity: eligible ...
Onsite
Ai/ml model validation and evaluation
Fda and iec regulatory standards knowledge
Medical device lifecycle development
Leica Biosystems is seeking a Principal AI Quality Engineer to lead quality assurance efforts for AI-driven medical device software. The role requires extensive experience in quality assurance within regulated industries, particularly in AI/ML, and offers a collaborative work environment focused on advancing cancer diagnostics

Job Summary

  • This role leads quality assurance efforts for AI-driven medical device software to ensure safety and regulatory alignment.
  • The position involves partnering with R&D, clinical, and regulatory teams to guide AI solutions through rigorous quality processes.
  • Candidates will work in a culture of belonging at Leica Biosystems, contributing to the mission of advancing cancer diagnostics.

Matching Summary

Match Score: 85

Leica Biosystems is seeking a Principal AI Quality Engineer to lead quality assurance efforts for AI-driven medical device software. The role requires extensive experience in quality assurance within regulated industries, particularly in AI/ML, and offers a collaborative work environment focused on advancing cancer diagnostics.

Salary

Base: $160,000 - $180,000; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Comprehensive package including PTO, medical/dental/vision, 401(k)

Skills & Requirements

Must-have

  • AI/ML model validation and evaluation
  • FDA and IEC regulatory standards knowledge
  • Medical device lifecycle development
  • Risk management and hazard analysis
  • Design controls and verification activities

Nice-to-have

  • Good Machine Learning Practices (GMLP)
  • Post-market surveillance experience
  • Cybersecurity and interoperability knowledge
  • Mentoring junior team members
  • Global regulatory submission support

Key Requirements

  • Bachelor's or Master's degree in CS, Data Science, or related field
  • 5+ years of quality experience in medical devices or IVD
  • Deep expertise in regulated software and embedded software development

Work Rights

Not specified

Tailored Resume

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