1、 R & D management
(1) Organize and formulate technical innovation development plans and technical feasibility studies for the company's new products, new technologies, and new processes;
(2) Responsible for product design and development work, and supervise and control the development process to ensure the smooth development of new product development;
(3) Responsible for product design risk management planning and review, as well as product design change risk management;
(4) Assisting in product process validation, design validation, design transfer, and registration and system assessment;
(5) Establishing a company's technology platform to enhance its core competitiveness;
(6) Pre-research on the future business development of the company, such as product pre-research and technical pre-research, reserve technical resources in advance;
(7) Support the market and sales team to complete pre-sales promotion activities and after-sales services.
2、tracking industry information
Track the development direction of the industry and provide decision-making basis for the company's new product establishment.
1. Bachelor degree or above, major in macromolecule materials, bioengineering, etc.
2. More than 5 years of relevant work experience in medical device companies, more than 3 years of practical work experience in project management. For implanted medical device developers, it is preferred.
3, familiar with ISO13485/YY0287, to master the knowledge of biodegradable materials.
4, proficient in project management, English proficiency.
1, product development and design
(1) Design new products according to product requirements, including structure and material selection;
(2) Responsible for the supplier's selection, follow up the sample delivery progress of the part sample, and evaluate the sampled parts to ensure that they meet the sample preparation requirements;
(3) Leading the completion of sample assembly and design improvements in the technical issues that arise during the assembly process;
(4) Responsible for formulating the sample evaluation plan and testing according to the plan to confirm whether the sample meets the design input requirements.
2, write product development technical documentation
(1) Preparation of technical research reports, product requirements, technical feasibility analysis reports at the input stage;
(2) Output product design documents, including drawings, purchase materials list and related material standards;
(3) Preparation of hazard analysis and product risk analysis related documents;
(4) Design and prepare product instruction manuals and packaging labels;
(5) Drawing BOM and process flow diagrams and compiling corresponding process documents accordingly;
(6) Preparation of related patent documents.
3, support product design verification, registration process
(1) Participate in product design verification and sign relevant plans and reports.
(2) Provide the relevant technical documents required for registration.
(3) Participate in product clinical trials, marketing promotion and after-sale technical support.
1. Bachelor degree or above, major in polymer materials.
2. More than 3 years of related work experience, preferred for implanted medical device developers.
3, familiar with common medical polymer materials, master the knowledge of biodegradable materials; understand the ISO13485 quality management system requirements for product development and product realization process.
4, skilled use of 2D / 3D design software; have a certain degree of English listening and speaking ability.
5. The work is serious and responsible, meticulous and meticulous; there is a good spirit of innovation, communication skills and teamwork.
1. Responsible for assisting R&D engineers in making and testing samples for new product development;
2. Responsible for the design of simple tooling required for sample production;
3. Provide technical support for production and quality inspection.
1 Between 18 and 30 years of age, senior high school or above, major in science and engineering;
2. More than one year of related work experience, experience in medical device manufacturing is preferred;
3. Easy to communicate, strong hands-on ability, dare to express ideas, and be pragmatic.
Changzhou Panda Medical Co., Ltd
Monday to Sunday 00:00-24:00
Address: 4th Floor, Building C2, No. 9 Changyang Road,
West Taihu Science and Technology Industrial Park,
Wujin District, Changzhou City, Jiangsu Province
Shanghai Panda Medical Co., Ltd.
Monday to Sunday 00:00-24:00
Address: Floor 3，No. 3, Lane 215，Hupo Road, Pudong New District, Shanghai