Roles and Responsibilities:
1. Responsible for the project management and life cycle management of medical device product design and development;
2. Set up project team, formulate project plans and key paths, and reasonably allocate tasks;
3. Responsible for the whole life-cycle design and development process management of medical devices from design input, sample design, design verification, clinical trial, design confirmation, product registration, design transfer to product mass production and marketing;
4. Follow up project implementation, report project’s progress to management regularly, and be responsible for the project progress;
5. Formulate project budget plan, control project cost and final product cost;
6. Ensure project quality objectives and achieve the final quality product quality requirements;
7. Allocate resources, coordinate, track and solve problems in project implementation;
8. Responsible for project risk management and change management;
9. Approved project’s design documents including DHF and DMR;
10. Support marketing and sales team to complete pre-sales promotion activities and after-sales service;
11. Follow up on new development of the industry and provide data for company's new product development plans;
12. Complete other work assigned by the superior.
Qualification:
1. Bachelor degree or above, major in Mechanical , materials or polymer materials, electronics, mechatronics, electrical engineering and other related science and engineering
2. At least 5 years of product research and development project management experience in life science industry, with large project management experience is preferred;
3. Proficient in demand analysis, WBS, risk, change, quality, process, procurement, finance and production management during the project;
4. Proficient in using MS Office and project management tools;
5. Familiar with medical device laws and regulations, design and development process is preferred;
6. PMP quali