Sr. Manufacturing Engineer
Katalyst HealthCares & Life Sciences
Sr. Manufacturing Engineer 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 Katalyst HealthCares & Life Sciences
Vacancy posted 5 days ago
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