Job description

Majors required: mechanical design, polymer, bioengineering materials, medical devices and other correspoding industries

Experience required:

3-5 years of experience in medical device product development , participated or independently developed new products, having central venous products (CVC, PICC, PORT, etc.) development experience is an advantage.

Resposibilities

1. In charge of the preparation for product design and planning, input, output, verification, confirmation, conversion, change and other related documents, complete the verification and confirmation of key processes and special processes of products;

2. In the process of Research and Development, to assist the Quality Department to fulfill the inspection of purchasing, manufacturing , finished products ,and assist the Registration Department to complete the declaration of new products and the registration of design modification of old products;

3. Skillful using 2D and 3D softwares to draw product parts ;

4. Be able to independently design and optimize products structures, produce tooling fixtures, understand the properties of polymer materials and related processes such as bonding, injection molding, extrusion, machining of metal materials, surface treatment and other processes;

5. Having experience in polymer material injection molding and pipe extrusion is an advantage.

Responsibilities:

1. Innovate and design new products conforming to product design requirements and plans, anufacturing new products with stable functions under the premise of  standards.

2. Responsible for new product drawings.

3. Responsible for the processing and manufacturing new product parts,which are ensured producible, and finally making production process parameters.

4. Test product design through small batch trial production of samples, and improve the design perfectly to meet the design input requirements.

5. Responsible for making sample production process verification plan, implementation of verification and writing verification report.

6. Organize product design review, implement and solve the problems raised in the review.

7. Complete the work temporarily arranged by the leader.

 Requirements:

1. Major in mechanical design, mechatronics engineering or automation related; Medical device processing experience is an advantage;

2. Familiar with AutoCAD, Inventor, SolidWorks and other software;

3. Have technical experience in medical devices manuducturing;

4.Familiar with medical device product validation;

5. Careful, serious and responsible, with team spirit.

Working Experience:

At least 1 year experience in medical instrument manufacturing.

Comprehensive abilities:

Strong sense of responsibility, good at communication and coordination ,analysing and problem solving with teamwork ability.

Well paid, benefits negotiable for top tallents.

Responsibilities:

1. Innovate and design new products conforming to product design requirements and plans, anufacturing new products with stable functions under the premise of  standards.

2. Responsible for new product drawings.

3. Responsible for the processing and manufacturing new product parts,which are ensured producible, and finally making production process parameters.

4. Test product design through small batch trial production of samples, and improve the design perfectly to meet the design input requirements.

5. Responsible for making sample production process verification plan, implementation of verification and writing verification report.

6. Organize product design review, implement and solve the problems raised in the review.

7. Complete the work temporarily arranged by the leader.

 Requirements:

1. Major in mechanical design, mechatronics engineering or automation, medical device processing experience is preferred;

2. Familiar with AutoCAD, Inventor, SolidWorks and other software;

3. Experience in the production technology of balloon products of medical devices;

4. Familiar with medical device product validation;

5. Careful, serious and responsible, with team spirit

Working Experience:

1. At least 1 year working experience in medical device technology manufacuring ;

2. Familiar with the quality management standards of sterile medical devices;

3. Major in mechanical design, material science, medical devices, etc.

4. Steady, practical, good at logical thinking;

5. Excellent learning ability, team work spirit, and communication skills.

Comprehensive Ability:

Strong sense of responsibility, communication and coordination , analysing and problem solving and teamwork ability.

Well paid, benefits negotiable for top tallents.

 Responsibilities:

1. Responsible for the inspection and registration of medical devices;

2. Cooperate with R&D department to collect, summarize and compile registration documents;

3. Responsible for following up the progress of medical device registration and  feedback;

4. Responsible for identifying, collecting  medical device regulations and standards of r&d products;

 Requirements:

1. Bachelor degree or above in medical device related field, at least 2- year experience in product registration in class III medical device, with experience of the whole process of registration;

2. Familiar with medical device quality management system;

3. Steady and practical , strong logical thinking;

4, Good learning ability, team work spirit, good communication skills.

Working Experience:

 At least 2- year experience in product registration of class III medical devices

Comprehensive Ability: 

Strong sense of responsibility, communication ,coordination ability, analysing and problem-solving ,and team work ability.

Well paid, benefits negotiable for top talents.

 Responsibilities:

1. Assist r&d engineers in developing new medical device , including planning, input, output, verification and transformation of new products;

Requirements:

1. Major in mechanical design, material science, medical equipment, etc.;

Working  Experience:

1. New Graduates

Comprehensive Ability:

1. Strong sense of responsibility, good communication and coordination skills, excellent at analysing and problem-solving  with teamwork ability.

Responsibilities:

1. Responsible for developing new medical device , including  planning, input, output, verification and transformation of new products;

2. Assist the project manager to coordinate relationships among developments of manufacturing, quality and procurement  according to the assigned plans and tasks of new  project ,and promote  the  r&d projects going smoothly;

3. Responsible for new product BOM, raw material, semi-manufacured  and manufactured products standard, production operation procedures, parts and assembly drawings and other technical documents;

4. Responsible for selecting material suppliers and confirming material conformity;

5. Mold processing and equipment selection;

6. Responsible for the implementation of new product process verification, preparation of the scheme, and organize relevant personnel to implement, and finally determine the product process;

7. Responsible for new product transfer training,  production education, quality and procurement related personnels, so that mass production can meet the established requirements;

8. Other tasks assigned by superior leaders.

Requirements:

1. Major in mechanical design, material science, medical equipment, etc.;

2. Experience in developing intravenous infusion products, such as PORT, PICC and other products;

3. Familiar with solidWord, PROE and other 3D and 2D design software;

4. Proffessional in  quality management standards of sterile medical devices, and be familiar with the design and development process of medical devices.

Working Experience:

At least 3- year experience in medical device design or technical position.

Comprehensive Ability: 

Strong sense of responsibility, communication and coordination ability, analysing ,problem-solving and team work ability.

Well paid,  benefits negotiable for top tallents. 

 Responsibilities:

1. Responsible for developing new medical devices, including planning, input, output, verification and transformation of new products;

2. Assist the project manager to coordinate departments work of production, quality and procurement  according to the assigned project and tasks of developing and promoting the  r&d projects projet going smoothly.

3. Responsible for new product BOM, raw material, semi-manufactured and  manufactured products standard, production operation procedures, parts and assembly drawings and other technical documents;

4. Responsible for selecting material suppliers and confirming material conformity;

5. Mold processing and equipment selection;

6. Responsible for the implementation of new product process verification, preparation of the scheme, and organize relevant personnels to implement, and finally determine the product process;

7. Responsible for new product transfer training,  production education, quality and procurement related personnel training, so that mass production can meet the established requirements;

8. Other tasks assigned by superior leaders.

 Requirements:

1. Major in mechanical design, material science, medical equipment, etc.;

2. Experience in balloons development and production;

3. Familiar with solidWord, PROE and other 3D and 2D design software;

4. Well-known of the quality management standards of sterile medical devices, and be familiar with the design and development process of medical devices.

Working Experience:

At least 3 years of experience in medical device design or technical position;

Comprehensive ability: 

Strong sense of responsibility, communication and coordination ability, analysing and problem-solving  with  team work ability.

Well paid, benefits negotiable for top talents.

 Responsibilities:

1. Fulfill physical and chemical analysis and testing as required, develop new physical and chemical testing projects, and assist in the maintenance and management of laboratory instruments and equipment; Carry on various microorganism culture experiments and strain identification as required, master aseptic operation;

2. Fulfill the verification work of physical and chemical inspection machine and issue reports; Complete the verification work of microbiological testing machine and issue the report;

3. Purchase, maintain  reagents, instruments and equipment required for daily physical and chemical testing/microbial testing;

4. Analysis and summary of abnormal physical and chemical experiments/microbial detection;

5. Complete other tasks assigned by superior leaders.

 Requirements:

1. College degree or above, major in applied chemistry, biological engineering or related;

2. Be familiar with medical device quality management system with system auditor certificate.

3. Skilled in laboratory physical and chemical analysis, microbial analysis, ion chromatography, gas chromatography and other operations;

Working Experience:

  1 year or more working in medical instrument lab

Comprehensive Ability: 

Strong sense of responsibility, communication and coordination ability, analysing and problem-solving and team work ability.

Well paid, benefits negotiable for top tallents.

 Responsibilities:

1. Organize and improve the medical device quality management system and monitor it  to ensure its effective operation;

2. Supervise and inspect the documents management of the company's quality management system and the inspection of key manufacuring processes, review and check the original records;

3.Responsible for review and evaluation the records of batch production ;

4. Organize and manage quality management activities such as deviating investigation and changing control according to management and operation procedures;

5. Responsible for self-inspection of the company's quality system, making self-inspection plans, coordinating the establishment of self-inspection teams and completing self-inspection work and reports;

6. Participate in the analysis and review of department nonconformities, and organize the implementation of corrective and preventive measures; '

7. Supervise the implementation of corrective and preventive measures on production site and report to superior in time.

8. Responsible for the quality process control on the production site, and standardize the operation of retention sample and sampling.

Requirements:

1.Familiar with medical device quality management system, such as ISO13485 management system, sterile medical device

Production quality management standard. Medical device production quality management standard (implant) is preferred, medical device internal auditor certificate is preferred;

2. Organized or participated in the daily management of medical device quality management system. Having participated in the audit of provincial bureau or above regulatory bodies is preferred;

3. Major in biological science, Medical device, Clinical Medicine, material science, Laboratory science, etc.

Working Experience:

At least 1 year experience as aseptic medical device QA engineer

Comprehensive ability: 

Strong sense of responsibility, communication and coordination ability, analysing and problem-solving ability with team work ability.

Well paid,benefits negotiable for top talents.

 Responsibilities:

1. Complete physical and chemical analysis and testing as required, develope new physical and chemical testing projects, and assist in the maintenance and management of laboratory instruments and equipment; Complete various microorganism culture experiments and strain identification as required, master aseptic operation;

2. Complete the verification work of physical and chemical inspection machine and issue the report; Complete the verification work of microbiological testing machine and issue the report;

3. Purchase, maintain reagents, instruments and equipment required for daily physical and chemical testing/microbial testing;

4. Analysis and summarize abnormal physical and chemical experiments/microbial detection;

5. Complete other tasks assigned by superior leaders.

 Requirements:

1. College degree or above, major in applied chemistry, biological engineering or related;

2. Be familiar with medical device quality management system with auditor certificate.

3. Skilled in laboratory physical and chemical analysis, microbial analysis, ion chromatography, gas chromatography and other operations;