Process Engineer

Process Engineer (Medical Device Industry)

Job Responsibilities

• Develop, optimize, and standardize manufacturing processes for medical devices/consumables to ensure process stability, traceability, and compliance.
• Lead New Product Introduction (NPI), including DFM review, process development, IQ/OQ/PQ validation, pilot run, mass production ramp-up, and handover.
• Develop and update SOPs, Control Plans, PFMEA, and inspection specifications in compliance with ISO13485/ISO9001 and medical regulations.
• Address process deviations and non-conformities; conduct RCA, CAPA, and mistake-proofing to improve yield and reduce rework/scrap.
• Manage evaluation, acceptance, maintenance, and validation of tooling and equipment to meet medical production precision and cleanliness requirements.
• Collaborate cross-functionally with production, quality, R&D, procurement, and suppliers to drive continuous improvement and cost optim...