CNC Manufacturing Engineer

TechDigital Group; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading MedTech firm in Indiana is seeking a skilled professional to validate CNC equipment and related processes used in manufacturing medical devices. This role requires proficiency in validation documentation and compliance with GMP/ISO standards. Candidates should have a Bachelor’s degree in engineering and 3–7 years of experience in CNC manufacturing. The position offers a dynamic work environment with opportunities for collaboration across various departments.

Qualifications

• 3–7 years in CNC manufacturing and equipment validation in a regulated environment.
• Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820.
• Experience with metrology, calibration, and measurement system analysis.

Responsibilities

• Develop and execute validation activities for CNC machines.
• Create and maintain validation documentation (IQ, OQ, PQ).
• Lead the Master Validation Plan and conduct risk assessments.
• Collaborate with various departments to qualify new machines.
• Analyze process data to demonstrate repeatability and accuracy.
• Provide training to operators and maintenance staff.

Skills

Manufacturing Process

CAM programming

GD&T

Product design

New product introduction

CNC machinery

Statistical tools (Minitab, JMP)

Risk management (ISO 14971)

Education

Bachelor’s degree in mechanical engineering

Bachelor’s degree in Manufacturing Engineering

Bachelor’s degree in Biomedical Engineering

Tools

Minitab

JMP

MasterControl

ETQ

Job description

Mandatory Skills

• Manufacturing Process, CAM programming – Expertise
• GD&T, product design and development – Good
• New product introduction projects – Good

Job Overview

• 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: 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.