Sr. Manufacturing Engineer

About the Role

We are seeking an experienced Senior 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 MasterControl or ETQ