Immediate Support needed on priority with medical domain experience must.(Sr. Manufacturing engineer

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:

o    Proficiency in developing and executing IQ/OQ/PQ protocols.

o    Experience with metrology, calibration, gauge R&R and measurement system analysis.

o    Knowledge of CNC machines, CAM software, and basic CNC programming concepts.

o    Statistical tools experience (Minitab, JMP, or similar) for process capability studies.

o    Lead Master Validation Plan, risk assessments (FMEA), CAPA

o    Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.).