Summary: We are looking for an experienced Sr. Manufacturing Engineer with a strong background in manufacturing engineering, equipment validation, and medical device manufacturing within a regulated environment.
Requirements:
Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or a related field
5+ years of experience in manufacturing and equipment validation (MedTech, Pharma, or Healthcare Devices)
Strong knowledge of ISO 13485, GMP, 21 CFR Part 820, and ISO 14971 risk management principles
Hands-on experience developing and executing IQ/OQ/PQ validation protocols
Expertise in Master Validation Plans, FMEA, CAPA, and validation documentation
Experience with metrology, calibration, Gauge R&R, and Measurement System Analysis (MSA)
Knowledge of CNC machines, CAM software, and basic CNC programming concepts
Experience with statistical analysis tools such as Minitab or JMP for process capability studies
Familiarity with Document Control and eQMS platforms such as Master Control or ETQ