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Mechanical Engineer

Job responsibilities:

1. Participate in product mechanical system and structure design;

2. Participate in prototype production, system verification and confirmation, preparation and sorting of project related technical documents;

3. Participate in the selection and certification of mechanical related materials;

4. Participate in technical communication and problem solving in the outsourcing process of product mechanical parts;

5. Handle temporary mechanical and structural tasks.


Job requirements:

1. College degree or above in mechatronics, machinery, automation, electronics and electrical and other related majors, with experience in mechanical structure development is preferred;

2. Have a solid mechanical design foundation and be able to independently complete product development and design work;

3. Proficient in using Solidworks, AutoCAD and other software, and proficient in using Office software;

4. Can understand the circuit wiring diagram, and can independently carry out PCB circuit board welding is preferred;

5. Familiar with the use of Altium Designer is preferred;

6. Experience in mechanical system design of moving parts is preferred.


PE Engineer (Zhuhai)

Job responsibilities:

1. Responsible for the investigation, handling and statistical reporting of accidents caused by technological reasons, and participate in the investigation and handling of relevant accidents;

2. Organize, implement and inspect the safety technical training and assessment of production operators in each production unit;

3. Responsible for organizing the safety inspection of process technology, go deep into the site, and solve the problems existing in the process technology in time;

4. Establish product standard working hours, and update labor and cost on a monthly basis or as appropriate for capacity analysis;

5. Lead the introduction of new products, determine the process operation standards, and produce estimated production hours;

6. Research and improvement of operating methods, rationalization analysis of production tools, instruments and equipment, and suggestions;

7. Establish production equipment capacity load analysis data;

8. Formulate and issue the operation process, improve the operation process, improve the productivity and reduce the cost.


Job requirements:

1. Responsible for the investigation, handling and statistical reporting of accidents caused by technological reasons, and participate in the investigation and handling of relevant accidents;

2. Organize, implement and inspect the safety technical training and assessment of production operators in each production unit;

3. Responsible for organizing the safety inspection of process technology, go deep into the site, and solve the problems existing in the process technology in time;

4. Establish product standard working hours, and update labor and cost on a monthly basis or as appropriate for capacity analysis;

5. Lead the introduction of new products, determine the process operation standards, and produce estimated production hours;

6. Research and improvement of operating methods, rationalization analysis of production tools, instruments and equipment, and suggestions;

7. Establish production equipment capacity load analysis data;

8. Formulate and issue the operation process, improve the operation process, improve the productivity and reduce the cost.


Medical Device NPI Engineer

Job responsibilities:

1. Responsible for the design conversion and introduction of new medical equipment products, and responsible for the implementation and management of manufacturing conditions in the research and development process;

2. Responsible for product manufacturability requirements in the new product development process and product maintenance process, DFMEA and manufacturability acceptance;

3. Responsible for leading the preparation of technical documents, including the development and confirmation of product process flow, process instruction, PFMEA, and inspection process, to ensure product process quality, and to be responsible for continuous improvement of online product process quality;

4. According to product and project requirements, be responsible for the verification and aging of products before mass production, verify key processes and equipment, ensure that mass production is imported on time and ensure product yield;

5. Lead the product review in the design transition stage, the summary meeting in the trial production stage, and the transition to mass production review;

6. Responsible for external auditing, management and provision of relevant jury materials.


Job requirements:

1. Bachelor degree or above in machinery, electronics, biomedical instruments, life sciences and other related majors.

2. Proficient in operating office automation software and drawing software such as AutoCAD, SolidWorks or Altium Designer.

3. More than two years of product follow-up experience, medical device industry is preferred; good at cross-departmental communication and collaboration;

4. Familiar with molecular biology experiments is preferred; familiar with the registration process of R&D products; project follow-up experience is required, and the transfer of new product projects can be successfully completed;

5. Be meticulous and rigorous, well organized, logical, and work conscientiously and responsibly.

6. Good communication skills, interpersonal skills, enthusiasm for work, active service awareness, and team spirit.


Domestic Registration Commissioner

Job responsibilities:

1. Responsible for the declaration and registration of the company's products, arrange the registration progress according to the company's product planning, and supervise the whole process of product registration;

2. Responsible for drafting and compiling standardized documents, sorting and compiling product registration materials, confirming and submitting registration applications;

3. Responsible for collecting relevant laws, regulations, rules and other regulations related to the operation of medical devices, compiling a quality management system, implementing dynamic management, and establishing archives and catalogues to ensure the integrity, accuracy and traceability of the records of various quality activities ;

4. Responsible for guiding and urging relevant departments and post personnel of the enterprise to implement the regulations and implementation rules of medical devices;

5. Responsible for handling medical device quality complaints, supervising the implementation of rectification measures, and cooperating with the management of medical device adverse event collection and recall;

6. Responsible for daily communication with food and drug administrations, inspection and testing institutions, technical review centers or clinical trial institutions.


Job requirements:

1. Bachelor degree or above, major in biomedical engineering, biology, medicine, clinical medicine or related;

2. More than 3 years of work experience in medical device registration, and those who have successfully registered three types of medical devices (in vitro diagnostic instruments and reagents) are preferred;

3. Familiar with the national NMPA and EU IVDR and other overseas medical device registration procedures and related guidelines;

4. Familiar with the national NMPA and ISO13485 and other regulatory systems related to the quality management of medical devices;

5. Proficient in using office software such as office;

6. Have a serious work attitude and sense of responsibility and good communication and coordination skills.


System engineer

Job responsibilities:

1. Lead the overall scheme design and project management of the IVD product system, be responsible for demand analysis, feasibility analysis, technical risk assessment, hardware design and selection, system integration, and lead the team to complete the writing of relevant documents in the new product project development stage;

2. In the process of product development, define the design requirements of each module in the system, organize the design verification of each technical module, and ensure the overall realization of the system scheme;

3. Organize product reliability testing to ensure product safety and reliability;

4. Instruct each module development team to formulate subsystem plans, manage and define system configuration;

5. In the process of project development, identify product system risks, carry out risk management, and assist professional groups to analyze and solve system problems;

6. Support and assist in completing other tasks assigned by leaders and related work.


Job requirements:

1. Master's degree or above, major in electronics, communication, computer, machinery, automation, biometrics, etc.;

2. More than two years of development work experience, have a certain knowledge and understanding of IVD product technical route and development direction, and have system design and project management experience of listed products: a. Electromechanical modules b. Product and appearance design c. Real-time Control software, which can independently analyze product problems;

3. Experience in the following system design is preferred: sample analysis system (organic, inorganic, biological tissue), detection system (environment, toxic substances, drugs, biomolecules, proteins), measurement system (temperature, optics, pressure, etc.);

4. Familiar with the product development process, have a certain basic knowledge of medical equipment regulations and standards, and solid manufacturing process knowledge;

5. Familiar with risk management, reliability design and other methods and tools;

6. Good interpersonal communication skills and teamwork skills, good at learning, strong sense of responsibility and strong initiative;

7. Obey the leadership arrangement, with strong learning ability and pressure resistance ability.


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