Principal AI Quality Engineer
Core
Lead quality assurance and regulatory compliance for AI/ML-driven medical device software, ensuring safety and effectiveness in cancer diagnostics.
Role type
Principal AI Quality Engineer (Regulatory & V&V)
Builds
AI/ML medical device software solutions for cancer diagnostics
Domain
Life sciences / Medical devices / AI/ML
Deliverable
production ML models
Required skills
AI/ML model validation, regulated software development, risk management, regulatory standards knowledge, project management, cross-functional leadership
Preferred skills
Good Machine Learning Practices (GMLP), post-market surveillance, cloud-based SaMD deployment, cybersecurity, interoperability
Technologies
FDA 21 CFR Part 820, IEC 5338, ISO 13485, IEC 62304, FDA AI/ML guidance
Responsibilities
Lead AI/ML lifecycle quality activities including V&V best practices and CAPA; Partner with data scientists and clinical experts to ensure regulatory alignment; Support global regulatory submissions (FDA 510(k), IVDR CE); Mentor junior engineers and drive cross-functional collaboration
Seniority
Principal, strategy & mentorship
