Sr. CNC Manufacturing Engineer

Job Title : Sr. CNC Manufacturing Engineer

Location : Warsaw, IN (Onsite)

Experience : 3-7 Years

Job Summary

We are seeking a skilled and detail-oriented Sr. CNC Manufacturing Engineer to lead equipment and process validation activities within a regulated medical device manufacturing environment. This role focuses on validating CNC machines and associated tooling to ensure compliance with GMP and ISO 13485 standards. The ideal candidate will have strong technical expertise in CNC machining, process validation (IQ / OQ / PQ), and statistical process analysis to deliver robust, reproducible manufacturing operations that meet all quality and regulatory requirements.

Key Responsibilities

Develop and execute validation protocols (IQ, OQ, PQ) for CNC equipment, tooling, and work-holding systems.

Lead creation and maintenance of Master Validation Plans, risk assessments (FMEA), and ensure compliance with ISO 13485, GMP, and 21 CFR Part 820.

Collaborate with Manufacturing, Quality, Regulatory, and Equipment Engineering teams to qualify new CNC machines and manage change control processes.

Plan and execute calibration, metrology, and Gage R&R studies to maintain traceability and measurement accuracy.

Analyze process data using statistical tools (Cp / Cpk, Gage R&R, etc.) to validate performance and ensure process control.

Prepare, review, and approve validation documentation including reports, deviations, CAPAs, and non-conformances.

Support supplier qualification and acceptance testing for CNC-related components and fixtures.

Train production and maintenance teams on validated processes and documentation practices.

Ensure audit readiness through proper documentation control, record retention, and adherence to change management procedures.

Maintain complete equipment lifecycle documentation, including maintenance schedules, calibration plans, and software / firmware updates.

Participate in root cause investigations related to CNC equipment or process deviations.

Required Qualifications

Education : Bachelor's degree in Mechanical, Manufacturing, or Biomedical Engineering (or related discipline).

Experience : 3 7 years in CNC manufacturing, validation, or equipment qualification within a regulated MedTech, pharmaceutical, or healthcare device industry.

Regulatory Knowledge : Strong understanding of ISO 13485, GMP, and 21 CFR Part 820; familiarity with ISO 14971 risk management principles.

Technical Expertise :

Proven experience in IQ / OQ / PQ protocol development and execution.

Strong background in metrology, calibration, and measurement system analysis.

Hands-on knowledge of CNC machines, CAM software, and CNC programming fundamentals.

Proficiency in statistical software (Minitab, JMP, or similar) for capability studies and data analysis.

Experience with electronic quality management systems (eQMS) such as MasterControl or ETQ.

Communication Skills : Excellent written and verbal communication; capable of producing clear, audit-ready documentation and presenting technical findings effectively.