1. Responsible for the planning, development and post-market management of passive degradable implant product lines (such as orthopedic fixation devices, cardiovascular stents, soft tissue repair materials, etc.), and formulate product strategies and iterative routes.

2. Analyze market demand and competition pattern, explore clinical pain points and unmet needs, and promote product innovation and optimization;

3. Collaborate with the R&D team to complete product design, material verification and process development to ensure that the product meets clinical needs and regulatory requirements (such as biocompatibility, controllability of degradation cycle, etc.);

4. Lead the registration application work, coordinate with quality, regulations, production and other departments to complete the preparation of technical documents and clinical trial support;

5. Formulate product launch strategies, design academic promotion plans, and cooperate with medical experts (KOLs) to convey product value.

6. Train the sales team and provide technical support, collect feedback from end users, and drive product improvement and customer satisfaction.

7. Ensure that the products comply with domestic and foreign medical device regulations (such as NMPA, US FDA, EU MDR) and industry standards (ISO 13485).

1. Bachelor degree or above in biomedical engineering, polymer materials, chemical engineering, clinical medicine and other related majors, master's degree is preferred;

2. More than 5 years of experience in the medical device industry, including at least 3 years of product management experience in the field of implants or biomaterials; Experience in degradable materials (such as polylactic acid PLA, polycaprolactone PCL, etc.) is preferred;

3. Those who are familiar with the registration process of medical devices and have led the registration of Class II/III products will receive bonus points;

4. Proficient in medical device regulations and quality management system, with the ability to transform clinical needs into technical indicators;

5. Excellent market analysis, business planning and data-driven decision-making skills, and be able to independently complete competitive product analysis and pricing strategies. Excellent cross-departmental communication and project management skills to adapt to the fast-paced R&D environment.

6. Preferred: familiar with the degradation mechanism of degradable materials and in vitro and in vivo evaluation methods; Experience in overseas market expansion or knowledge of international regulations; It has clinical resources or channel resources in orthopedics, cardiovascular and other fields.

1. Develop new products according to the R&D system;

2. Learn the company's R&D skills, optimize mature product processes and develop new product processes;

3. Cooperate with registered personnel to write product technical documents;

4. Cooperate with the inspection department to write and verify product inspection methods;

5. Assist the quality department in preparing product research and development and system documents;

6. Implement the process transformation from product research and development to production, and connect with production personnel to determine relevant technical parameters;

1. Have good English literature reading skills, master's degree is preferred, bachelor's degree or above is required;

2. Mechanical and polymer materials and other engineering majors, familiar with a 3D modeling software;

3. More than two years of R&D experience in the medical device industry;

4. Product developers who have worked on passive implants are preferred;

5. Familiar with the medical device product development process and ISO13485 quality system, and have priority in participating in animal experimental design or actual operation.

1. According to the company's design products, carry out 3D printing processing, and produce according to the process;

2. Communicate with the design engineer to understand the required structural functions and judge whether the design data meets the manufacturing requirements.

3. Process verification of the designed product (small batch trial production, process confirmation);

4. Responsible for the daily operation and abnormal disposal of the process module;

5. Responsible for the daily management, maintenance and upgrading of equipment and production lines to ensure process reliability;

6. Complete other tasks assigned by superiors;

1. Bachelor degree or above, with 3D printing, three types of passive implantable medical devices, absorbable material experience, and medical-industrial background is preferred;

2. Experience in SLA process and FDM process is preferred;

3. Proficient in 3D printing manufacturing software and auxiliary software (Magics, Cura, Python), data processing and analysis software (Excel or Origin), modeling software (UG or Solidworks);

4. Serious and pragmatic, responsible and teamwork;

5. Have strong self-learning ability and certain communication skills;

6. Take the initiative to explore potential defects and take necessary measures to avoid problems.

1. Lead the preparation and review of medical device product technical requirements, manuals and other registration and application materials;

2. Responsible for the innovation declaration, registration declaration, expert consultation meeting, registration and subsidy of Class II/III medical devices;

3. Participate in the verification of medical device production quality management system;

4. Pay attention to the relevant policies and information released on the websites of the National Medical Products Administration and the Provincial Drug Administration, and keep abreast of the relevant policies and latest developments in medical device registration.

5. Responsible for the withdrawal of medical device registration applications and other work related to medical device registration applications;

6. Participate in the review of medical device preclinical trials and clinical trial plans, and connect with the relevant work of clinical trials;

1. Bachelor degree or above, medical device-related major is preferred;

2. More than 3 years of work experience related to medical device registration;

3. The number of medical devices participating in the declaration of Class III is not less than 3;

4. Familiar with the laws, regulations, rules and relevant regulations of medical device registration and filing management;

5. Have good organization, communication and coordination skills;

6. Have strong learning ability and be able to keep abreast of the latest developments of medical device registration policies and products.