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

2. Cooperate with the registrant to write the technical documents.
3. Cooperate with inspection department to write and validate product inspection method.
4. Assist Quality Department to prepare product development and system documents.

5. Carry out the process transformation from product development to production, and determine the relevant technical    parameters with production personnel.

1. Good English reading ability, master degree is preferred, bachelor degree or above is required.

2. Familiar with a 3D modeling software, with structural engineer-related skills.
3. More than two years R & D Experience in medical device industry.
4. Familiar with medical device product development process and IS013485 quality system, have involved in the design of animal experiments or practical operation is preferred.
5. Carry out the process transformation from product development to production, and determine the relevant technical parameters with production personnel. experiments or practical operation is preferred.

1. Assist the sponsor to submit the ethics review documents and institutional filing documents to the research center, and follow up the progress of Ethics Review and institutional project approval.

2. Intervention Procedures, AE/SAE reporting, data recording requirements, etc. Verify that test supplies (instruments, CRF , EDC account number) are in place.
3. Conduct on-site inspections at research centres as planned to ensure that trials are conducted in strict accordance with clinical trial protocols, company SOP and GCP standards. Core tasks include: data verification: checking the consistency of source data such as original medical records and laboratory orders with CRF/EDC Records, ensure that data is"Attributable, clear, traceable, raw, and accurate"(Alcoa principle) .
4. The enrolled subjects were confirmed to meet the criteria, the informed consent form was signed, the follow-up plan was completed, and the compliance of the subjects was good. 
5. Track adverse event (AE) records and reports, with a focus on reporting SAE to the Ethics Committee, sponsor, and regulatory authorities in a timely manner as required by regulations, and verify SAE handling measures.
6. Check the storage conditions (temperature, humidity) , inventory records, distribution and recovery process of the test equipment; verify that the laboratory equipment is calibrated and the test results are traceable.
7. Communicate and record with researchers when data errors and program violations are found, track corrective actions until they are resolved, and write a"Monitoring report".
8. Monitor the enrollment progress of the research center, analyze the reasons for the slow enrollment, and assist researchers to optimize the recruitment strategy to ensure compliance with the overall time plan of the trial.
9. At the end of the clinical trial, all data were entered and verified before closure, and unresolved issues were closed. Participants were followed up, and SAE was tracked to the outcome. To assist in the recovery of the remaining test equipment, according to the prescribed process of destruction or return to the applicant, record the“Material Destruction/recovery certificate.
10. Verify that the research centre's trial documentation (ethics approvals, contracts, raw data, monitoring reports, etc.) is filed, complete and traceable as required by GCP.

1. Bachelor degree or above. Major in clinical medicine, pharmacy, nursing, biology, public health, etc.

2.  Have at least 1 full monitoring experience in Type 3 implants, 3 + years of clinical trial research experience, and GCP certification.
3. Familiar with the“Medical device clinical trial quality management code”, ICH-GCP guidelines, understanding of regulatory requirements such as NMPA. Be able to use office software skillfully. Good command of English, can use the tools to access the relevant literature.
4. Familiar with the whole process of clinical trial (start-up, enrollment, follow-up, close-up) , understand the protocol design logic (such as randomization, blinding, sample size calculation) .
5. Good communication skills and teamwork spirit, good written and oral communication skills.
6. Be able to work on business trip.

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

2. Learn Company R & D skills, process optimization of mature products and new product process development.

3. Cooperate with the registrant to write the technical documents

4. Cooperate with inspection department to write and validate product inspection method.

5. Assist Quality Department to prepare product development and system documents.

6. Carry out the process transformation from product development to production, and determine the relevant technical     parameters with production personnel.

1. Good English literature reading ability, bachelor degree.

2. Mechanical, polymer materials and other engineering, familiar with a three-dimensional modeling software.

3. More than two years R&D Experience in medical device industry.

4. Product developers with experience in passive implants will be a plus.

5. Familiar with medical device product development process and ISO13485 quality system, have the experience in animal       experiment design or practical operation is preferred.

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.