Job responsibilities:
1. Responsible for making project development plan, managing the project according to project milestones, and controlling the progress;
2. Responsible for the preliminary technical research, feasibility analysis and patent analysis of new products;
3. Responsible for organizing the design and development of new products, selection of raw materials, and solving technical problems in the development process;
4. Responsible for the preparation and review of DHF and DMR documents;
5, responsible for coordinating product design verification, aging, transportation verification, preparation of plans, implementation and reports;
6. Responsible for animal experiments of products, summarizing test reports and biological evaluation reports;
7, cooperate with the clinical department to coordinate the clinical evaluation or clinical trials of products and follow-up;
8, responsible for product registration process technical support;
9. Responsible for formulating the implementation plan of the product market entry plan.
Job requirements
1, 3 years or above experience in cardiovascular intervention or implantation product development;
2. Familiar with the whole process of product design and development, with experience in the whole process of product design and development, registration and clinical;
3, familiar with ISO13485 quality management system, medical device production quality management standards and risk management process;
4, have independent development ability, can learn quickly, have good communication skills and execution;
5, familiar with plastic, mold and machinery processing technology.