Production Engineer, SW

Responsibilities

• Lead process development and optimization for surgical beds, pendants, and surgical lights, including mechanical assembly, electrical wiring, and pneumatic system debugging.
• Manage the full product lifecycle by creating and maintaining core documents such as process specifications, work instructions, and validation master documents.
• Oversee the technical transfer of new products from R&D to mass production, coordinating with international teams to adapt technical drawings and quality standards.
• Provide on-site technical support to resolve production anomalies, perform root cause analysis, and implement long-term corrective actions.
• Design, optimize, and validate specialized tooling and fixtures to improve assembly precision and operational efficiency.
• Collaborate with Quality and Procurement departments to evaluate new materials, conduct non-conforming product analysis, and drive continuous improvement using DOE and FMEA.
• Ensure all manufacturing processes strictly comply with medical device GMP, ISO 13485, NMPA, and MDSAP regulatory requirements.

Requirements

• Bachelor's degree in Science or Engineering (preferred).
• 5+ years of experience working in a foreign-invested manufacturing environment.
• Proven knowledge of medical device assembly and testing processes.
• Fluent English communication skills (speaking, reading, and writing) are mandatory.
• Strong analytical thinking and problem-solving capabilities.

Preferred Qualifications

• GMP (Good Manufacturing Practice) certification.
• Experience with active medical device assembly and testing.
• Proficiency in using quality tools such as DOE and FMEA.

About the Company

Maquet (Suzhou) Co, Ltd. is part of Getinge, a global leader in medical technology. Getinge provides hospitals and life science institutions with advanced products and solutions for intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing. With over 12,000 employees worldwide, we are dedicated to making life-saving technology accessible to more people.