Production Engineer, ACT

Responsibilities

• Lead the establishment and maintenance of production process documentation for Class III medical devices, including work instructions and validation master documents.
• Manage the full lifecycle of process validation, including the coordination and execution of PV, IQ, OQ, PQ, and PPQ activities.
• Provide technical support on the production floor to resolve process abnormalities such as dimensional deviations or assembly defects.
• Drive New Product Introduction (NPI) and technical transfers from global R&D teams to local mass production.
• Lead process optimization projects using quality tools like DOE and FMEA to improve yield, efficiency, and cost-effectiveness.
• Collaborate with Quality and Procurement departments to evaluate new materials and conduct root cause analysis for non-conforming products.
• Conduct technical training for production staff and new technicians to ensure standardized process execution.

Requirements

• 5+ years of experience in medical device manufacturing.
• 3+ years of NPI experience specifically for Class II or Class III medical devices.
• Proficiency in mechanical design software, including AutoCAD and SolidWorks, for fixture and tooling design.
• Strong expertise in process validation protocols (IQ/OQ/PQ).
• Deep familiarity with international regulatory standards, including ISO 13485, FDA QSR 820, and EU MDR 2017/745.
• Hands-on experience with quality tools such as FMEA, SPC, and MSA.

Preferred Qualifications

• Experience with technical transfers from overseas R&D or manufacturing sites.
• Knowledge of extrusion, injection molding, or coating processes.
• ISO 13485 internal auditor certification.
• Proficiency in statistical analysis software such as Minitab.

About the Company

Maquet (Suzhou) Co, Ltd. is part of the Getinge Group. Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. We exist to make life-saving technology accessible for more people through our expertise in intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.