Sr. Manufacturing engineer

Title: Sr. Manufacturing engineer
Location: Warsaw, IN


Job Description:

• Education: Bachelor s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
• Experience: 5+ years in 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, gauge R&R 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.
• Lead Master Validation Plan, risk assessments (FMEA), CAPA
• Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.).