Sr Manufacturing Engineer
Raas Infotek
Education: Bachelor’s degree in mechanical engineering, manufacturing engineering, biomedical engineering, or a 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.) #J-18808-Ljbffr
Vacancy posted 11 hours ago
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