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Manufacturing Engineer with CNC

Manufacturing Engineer with CNC

Noblesoft Technologies

Warsaw, IN • On-site

$70.40K - $89.70K/yr

Contractor

Posted 2 days ago

Job description

    
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
 
  • 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.

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Frequently asked questions

Q: What skills or qualities help someone succeed as a CNC Manufacturing Engineer?

A: To succeed as a CNC Manufacturing Engineer, key technical skills include proficiency in computer-aided design (CAD) software, programming languages such as G-code, and experience with CNC machine tools and control systems. Soft skills like strong problem-solving abilities, effective communication, and collaboration with cross-functional teams are also crucial, as they enable engineers to troubleshoot complex issues, coordinate with production staff, and implement process improvements. By combining technical expertise with strong interpersonal and analytical skills, CNC Manufacturing Engineers can drive efficiency, quality, and innovation in manufacturing operations, ultimately supporting career growth and professional advancement.

Q: What is the career path for a CNC Manufacturing Engineer?

A: A CNC Manufacturing Engineer's career path typically begins as a Junior Engineer or CNC Programmer, where they develop skills in programming and operating CNC machines, and progress to roles such as CNC Supervisor or Manufacturing Engineer, overseeing production and implementing process improvements. Mid-level roles, such as Senior Manufacturing Engineer or Quality Engineer, involve leading cross-functional teams and driving innovation through the adoption of new technologies and methodologies. Senior roles, such as Manufacturing Manager or Director of Operations, require strategic leadership and expertise in optimizing production efficiency, quality, and cost, with opportunities to transition into related fields like operations management or product development.

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Noblesoft Technologies job posting for a Manufacturing Engineer with CNC in Warsaw, IN with a salary of $70,400 to $89,700 Annually with a map of Warsaw location.