Perform daily operation, preventive maintenance, fault diagnosis, and repair of production and mechanical equipment; develop maintenance plans to ensure stable and reliable equipment operation.
Do you have hands-on experience with medical device design controls, risk management (ISO 14971), and Design History Files (DHF)? If yes, please briefly describe your experience, including the types of Class II medical devices you worked on and your specific responsibilities.
Process & Compliance: Establish and maintain internal design procedures and approval workflows. Ensure all projects adhere to relevant regulatory, safety, and sustainability standards while maintaining meticulous documentation throughout the project lifecycle.