Leica Biosystems, a part of Danaher, is seeking a Principal AI Quality Engineer to oversee quality assurance for AI-driven medical device software. The ideal candidate will have extensive experience in quality assurance within regulated industries, particularly focusing on AI/ML compliance and safety
Job Summary
This role leads quality assurance efforts for AI-driven medical device software ensuring safety, effectiveness, and regulatory alignment.
The position partners closely with R&D, clinical, and regulatory teams to guide AI/ML solutions through rigorous quality processes.
The company offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) eligibility.
Matching Summary
Match Score: 85
Leica Biosystems, a part of Danaher, is seeking a Principal AI Quality Engineer to oversee quality assurance for AI-driven medical device software. The ideal candidate will have extensive experience in quality assurance within regulated industries, particularly focusing on AI/ML compliance and safety.
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
5+ years medical device quality experience
Deep expertise in AI/ML algorithms validation
Knowledge of FDA, IEC, ISO regulatory standards
Experience with Design History File development
Proven ability to lead AI-focused risk management
Nice-to-have
Familiarity with Good Machine Learning Practices
Experience with post-market surveillance monitoring
Knowledge of cybersecurity and interoperability
Strong presentation skills for technical stakeholders
Experience with cloud-based SaMD deployment
Key Requirements
Bachelor's or Master's degree in Computer Science or related field
Advanced degree preferred
5+ years of quality experience in medical devices or IVD