MedTech CNC Validation Engineer – IQ/OQ/PQ Expert

TechDigital Group; Warsaw (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

TechDigital Group in the United States seeks a skilled Validation Engineer to validate CNC equipment and processes used in medical device manufacturing. You will develop IQ/OQ/PQ protocols, maintain calibration and traceability, and ensure GMP/ISO compliance in a regulated environment.

You will lead validation planning, perform risk assessments, and collaborate with Quality Assurance, Regulatory Affairs, and Manufacturing to qualify new machines and implement change controls.

Qualifications

• 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).
• Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with ISO 14971 and validation concepts (IQ/OQ/PQ).
• Proficiency in developing and executing IQ/OQ/PQ protocols; 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.).
• Strong written and verbal communication; ability to present findings to cross-functional teams.

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, OQ, and PQ 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.

Skills

CNC manufacturing

Validation protocols

IQ/OQ/PQ development

Statistical analysis

Documentation & eQMS

Education

Bachelor's degree in mechanical engineering or related field

Tools

MasterControl eQMS

ETQ

Minitab/JMP

CAM software

Job description

TechDigital Group in the United States seeks a skilled Validation Engineer to validate CNC equipment and processes used in medical device manufacturing. You will develop IQ/OQ/PQ protocols, maintain calibration and traceability, and ensure GMP/ISO compliance in a regulated environment.

You will lead validation planning, perform risk assessments, and collaborate with Quality Assurance, Regulatory Affairs, and Manufacturing to qualify new machines and implement change controls.