Manufacturing Engineer with CNC

Title : Manufacturing Engineer with CNC

Location : Warsaw, IN

JD as below

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.

Key Responsibilities

• 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.

Required Qualifications