Principal Validation Engineer
Core
Perform validation of manufacturing processes, equipment, and systems to ensure compliance with safety guidelines and regulatory standards for medical devices.
Role type
Principal Validation Engineer
Builds
Validated manufacturing processes and equipment for medical devices
Domain
Medical Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation (CSV, IQ, OQ, PQ), GMP/FDA regulated industry experience, Manufacturing technologies (Lean, Six Sigma), Project management (MS Project, SharePoint), Equipment coordination (high-speed automated systems)
Preferred skills
None stated
Technologies
MS Project, SharePoint, Cognex Insight 5000/2000, Keyence CVX
Responsibilities
Prepare validation protocols for new or modified manufacturing processes; Analyze and document validation studies; Coordinate protocol execution with Operations, Maintenance, Engineering, and Quality; Plan project engineering schedules; Recommend process improvement activities
Seniority
Principal, hands-on IC
