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Manufacturing Engineer - CNC
TechDigital Corporation
- 🇵🇱 Poland | 🇺🇸 United States
- On-site
- 10 months ago
- CNC
- calibration
- GMP
- FMEA
- Change Management
- Risk Management
- Minitab
- JMP
10 months ago
- Role: 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.
- 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.
- 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.
- Provide training and knowledge transfer to operators and maintenance staff on validated CNC processes.
- 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: Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
- Experience: 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).
- Technical Skills:
- 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.).
- Communication: Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.
Manufacturing Engineer - CNC · TechDigital Corporation