Process Development & Technology Transfer Engineer

About the Role Join Getinge as a Process Development & Technology Transfer Engineer to lead manufacturing process development and optimization for surgical beds, gantries, and surgical lights. You will manage full lifecycle documentation, validate processes, and drive cross-border technology transfer to enable scalable production while ensuring GMP/ISO 13485 compliance. What You'll Do

• Lead process development and optimization for surgical beds, gantries, surgical lights, including mechanical assembly, electrical wiring, and pneumatic system debugging; manage lifecycle documents (process procedures, work instructions, validation master plans) and oversee periodic re-validation.
• Lead new product introduction and technology transfer from development to mass production; coordinate with foreign R&D/production teams; develop cross-border transfer plans; validate locally and train production teams; support regulatory document reviews ensuring compliance.
• Provide on-site technical support; quickly respond to process deviations; conduct root-cause analysis and implement temporary and long-term solutions to minimize downtime; perform process audits in production floor.
• Design and manage tooling/fixtures to address assembly accuracy, efficiency, and product protection; establish maintenance for equipment and fixtures.
• Collaborate with Quality, Procurement, and other departments to analyze non-conformities, drive process improvements using DOE and FMEA, ensure GMP/ISO13485 and NMPA/MDSAP compliance; participate in internal and external audits. What We're Looking For
• Bachelor's degree or above in science or engineering; science or engineering majors preferred.
• 5+ years of experience in a foreign-owned manufacturing environment; familiarity with active medical device assembly and testing preferred.
• GMP qualification/certification preferred.
• Fluent in English (listening, speaking, reading, and writing).
• Strong analytical thinking, problem-solving ability, and innovative mindset. Nice to Have
• Experience with multinational technology transfers.
• Experience with regulatory audits and quality systems.