Job responsibilities:
1 Responsible for the assembly manufacturing process and surface treatment process of new products, including defining the assembly process method, designing the tooling and fixture, and studying the process parameters;
2 Be responsible for formulating the validation and confirmation scheme of the process and organizing its implementation;
3 Be responsible for preparing process flow and operation instructions;
4 Organize the design transfer of new products, including small batch trial production, and prepare other relevant documents of DMR;
5 Continuously improve the production process and provide effective technical support for problems encountered in the production process;
6. Ensure that the technical documents of the process output meet the requirements of the medical system and laws and regulations;
1 Bachelor degree or above in mechanical design, mechanical and electrical engineering;
2 At least 3-5 years of relevant working experience in the process manufacturing of medical device enterprises, and experience in the production process development of Class II active medical device products is preferred;
3 Proficient in MS-OFFICE/AUTOCAD/SOLIDWORKS and other software;
4 Be familiar with ISO13485 standard requirements, have organized or participated in project process development and project technology transfer related work experience;