Job Responsibilities:

1. Organize and coordinate the registration testing of the declared products in accordance with relevant laws and regulations to ensure timely registration and testing reports;

2. Screening of clinical units, cooperation and communication, signing of contracts, preparation and filing of relevant materials, and clinical follow-up to ensure timely access to qualified clinical reports;

3. Guide or assist the relevant departments of the company to write and organize medical device registration documents, organize follow-up and rectification of experts and problem points, and supplement information, follow up the progress of registration, and ensure timely evidence collection;

4. Responsible for liaison with higher-level units such as the Food and Drug Administration, Registration and Evaluation Center, and Medical Device Supervision and Inspection Center;

5. Responsible for the publicity tasks of registration policies and regulations, and provide support and training on policies and regulations for the departments;

6. Responsible for team building, work assignment and assessment.

Job Requirements：

1. Biomedicine, biotechnology, clinical laboratory and other related majors are recruited for a bachelor degree or above, and those with rich experience can relax their majors;

2. More than 6 years of experience in medical device industry registration and application, and successful independent completion of medical device registration; more than 2 years of team management experience is preferred;

3. Familiar with the handling procedures of the drug administration, testing center and hospital, and have a good cooperative relationship with the above units;

4. Familiar with the registration process and related laws and regulations of medical devices, especially IVD products; those with clinical project experience are preferred; those with CE or FDA certification are preferred;

5. Strong writing and organizing material skills; good communication skills, good teamwork spirit, strong self-motivated and responsible sense.

Job Responsibilities：

Completed the R&D of electrochemical blood ketone body and uric acid rapid detection test strips

Job Requirements：

Majors in electrochemistry, analytical chemistry, physical chemistry, instrument analysis, biomedical engineering, printing and packaging, etc. College degree or above

Job Responsibilities：

1. Responsible for planning the work and staffing of the department, and put forward reasonable department work goals;

2. Responsible for supervising and guiding the establishment and operation of design transformation and trial production process, promote the process of new product design transformation, ensure product quality, and ensure that the product production process and production process meet the needs of large-scale production; organize the review of the process design of various products , To ensure the correctness and advancement of the process;

3. Review process planning and process operation instructions to ensure the standardized operation of production operations;

4. Organize small-batch trial production of products and review small-batch trial production reports;

5. Optimize and improve process methods and technology, and continuously improve production quality and technology;

6. Verify production capacity, give full play to equipment operating efficiency, verify production quotas (working hours, materials) for various products, and effectively control consumption;

7. Organize to deal with major technological problems in the production process to ensure that the problems are solved in time;

8. Supervise, inspect and correct on-site process discipline to ensure the effectiveness of process execution.

Department Management:

1. Organize and implement the tasks and objectives assigned by the company and be responsible for their results;

2. Formulate the job responsibilities of employees in this department;

3. Draw up the annual work plan of the department and arrange the work tasks of the employees of the department;

4. Supervise, inspect and evaluate the work of subordinate employees;

5. Motivate and train employees in this department.

Job Requirements：

1. Unified recruitment of bachelor degree or above, majors in electronics, mechanics, materials, automation, etc.

2. Familiar with IVD product performance and new product development process and related quality analysis;

3. More than three years of new product introduction work experience;

4. Familiar with daily office software such as AutoCAD and Coreldraw;

5. Have strong communication, coordination and problem analysis and resolution capabilities;

6. Complete other temporary tasks assigned by the leader.

Job Responsibilities：

1. New product process design, production process, tooling and fixture formulation

2. Process document production

3. Follow up the trial production of new products, feedback trial production problems, and put forward suggestions for rectification

4. Participate in the stage review of new products and put forward reasonable suggestions

5. Organize process review of new and old models of products to ensure the accuracy and suitability of process documents

6. Analysis of problem products, formulate and implement corrective and preventive measures

7. Development and review of standard working hours

8. Supervision and inspection of production process technology execution

9. Instruct employees to work methods

10. Handling of exceptions in the production process

11. Continue to optimize the process to improve production efficiency and product quality

12. Complete other temporary tasks arranged by superiors

Job Requirements：

1. More than 2 years of work experience in the medical equipment or instrumentation industry

2. Proficiency in using common drawing software and OFFICE software

3. Familiar with the assembly process of electronic products

4. You can use instruments such as oscilloscopes and multimeters

5. Those with welding, wire tie or circuit debugging capabilities are preferred