Senior Manufacturing/Process Engineer (Medical)

Job Detail

Position Summary: Owns assigned manufacturing processes, drives yield improvement, supports NPI and manufacturing transfer, and leads validation activities for medical device and IVD products. Key Responsibilities: Advanced Manufacturing Engineering Develop, optimize and sustain manufacturing processes for assigned product lines. Support DFM reviews, assembly optimization, equipment qualification and workstation design. Perform process capability studies and define improvement actions. Lean and Continuous Improvement: Lead value stream mapping, DMAIC, Kaizen, waste elimination and OEE improvement activities. Drive cost reduction projects through process simplification, layout improvement and equipment utilization. Use data-driven methods to improve line efficiency, yield and production stability. Validation Expertise: Own IQ/OQ/PQ activities for assigned equipment, processes or production areas. Perform Gauge R&R, process capability analysis, risk assessment and FMEA updates. Prepare validation reports, process release evidence and manufacturing readiness documentation. Medical Device Compliance: Apply ISO 13485 and FDA 21 CFR Part 820 requirements in daily engineering work. Support change control, CAPA, deviation management, traceability and DHR requirements. Participate in internal audits, customer audits and regulatory readiness activities. IVD-Specific Knowledge: Support processes involving fluidics assemblies, optics modules, motion control systems, reagent handling and environmental control requirements. Troubleshoot process-related failures on IVD analyzers or medical device equipment.