CNC MFG Engineer

Warsaw, IN - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Sr CNC MFG Engineer

Location: Warsaw IN

Job Description: JD as below

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.

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

Education: Bachelors 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.

Job Title: Sr CNC MFG Engineer Location: Warsaw IN Job Description: JD as below 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...

Job Title: Sr CNC MFG Engineer

Location: Warsaw IN

Job Description: JD as below

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.

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

Education: Bachelors 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.