Senior Engineer Validation
Core
Execute validation activities (IQ/OQ/PQ) to industrialize and transfer new medical device products into manufacturing, ensuring compliance with regulatory standards.
Role type
Senior Validation Engineer
Builds
Manufacturing-ready medical devices and production systems
Domain
Medical devices / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation lifecycle management, IQ/OQ/PQ execution, GMP/FDA/ISO 13485 compliance, risk assessment, traceability matrix development, process characterization
Preferred skills
PFMEA, Control Plans, PPAP, MSA, Gage R&R, statistical analysis (Minitab), New Product Development support
Technologies
Minitab, FDA QSR 21 CFR Part 820, ISO 60601
Responsibilities
Lead and execute Installation, Operational, and Performance Qualification activities; Develop and maintain validation documentation (plans, protocols, reports); Collaborate with R&D and Manufacturing to transfer products; Support pilot builds and production ramp-up
Seniority
Senior, hands-on IC
