Validation Engineer

Summary: Role: Lead and Validate CNC equipment and related processes used to manufacture medical devices. Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation. Roles & Responsibilities: Lead, Develop and execute validation activities for CNC machines (e.g., mills, lathes, multi-axis CNCs) and associated tooling/work holding. Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports. Proficiency in developing and executing IQ/OQ/PQ protocols. Experience with metrology, calibration, and measurement system analysis. Knowledge of CNC machines, CAM software, and basic CNC programming concepts. Statistical tools experience (Minitab, JMP, or similar) for process capability studies. Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.). Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory requirements (ISO 13485, GMP, 21 CFR Part 820). Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls. Design, execute, and document calibration, metrology, and gauge R&R activities; ensure traceability of measurement equipment. Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&R) to demonstrate repeatability, accuracy, and process control. Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances. Support supplier qualification and acceptance tests for CNC-related components and tooling. Ensure compliance with documentation control, record retention, and audit readiness; participate in internal/external audits. Maintain equipment lifecycle documentation (maintenance plans, calibration schedules, firmware/software updates) and ensure alignment with change management processes. Support manufacturing investigations and root-cause analyses related to CNC processes and equipment performance. Education & Experience: Education: Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline. 3–7 years in CNC manufacturing and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices). Regulatory & Standards: Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ).

Created: 2026-04-02