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Grand Future Medical Producte Co., Ltd.

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2025.01.06

Project Engineer


Job Description: 1. Responsible for the initiation and control of various internal R&D projects: preparing project development plans, identifying and controlling project risks, product development management, drawing review, project evaluation (DFM), process follow-up, production process, and production approval (PSW); 2. Effectively control the entire process and key stages of project development; 3. Product master BOM (including fixtures, packaging, and drawing collection); 4. 3D product assembly (check assembly gaps and project lists); 5. 2D part drawings (standard assembly tolerances and related requirements); 6. 3D mold design (tolerance reduction principles and mold protection); 7. Product trial assembly testing and required tools and fixtures; 8. Controlled management of the complete product drawing system; 9. Responsible for cross-department communication, effectively controlling customer requirements, and solving quality and management issues encountered during project development; 10. Master the control of the entire project process and coordinate the organization to complete the documentation for each stage of the project; 11. Host project initiation meetings; 12. Complete other tasks assigned by superiors. Job Requirements: 1. College diploma or above, in project management, mechanical, electronic, design, medicine, or related fields; 2. Possess project management skills, familiar with the preparation, process, and acceptance stages of project implementation and their requirements; 3. Proficient in using various office software, with more than 3 years of experience in medical device R&D project management; 4. Strong execution ability, strong sense of responsibility, good communication and teamwork skills; goal-oriented, good at planning and control; 5. PMP certification is preferred; 6. Familiarity with ISO13485 and APQP is preferred.

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2025.01.06

Research and Development Engineer


Job Description: 1. Develop or introduce new medical products and formulate relevant documents according to ISO13485 standards; 2. In terms of product design, the responsibilities include (but are not limited to): a) Responsible for the structural design/development of medical device products; b) Selection of materials and equipment; c) Literature/patent research; d) Sample development; e) Research, project initiation, management, application, and external cooperation for scientific research projects; 3. In terms of product manufacturing: product mass production conversion, process improvement, defect analysis, abnormal handling, etc. 4. Complete the recording of the entire product preparation process and laboratory operation records according to the quality system requirements. 5. Other tasks assigned by superiors. Job Requirements: 1. Education Level: Bachelor's degree or above in mechanical/materials/medical-related fields. 2. Knowledge: Certain knowledge of medical device products, medical device systems, and project management. 3. Skills: a) Proficient in using drawing software such as AUTO CAD, SolidWorks, or Pro-E; b) Proficient in using office software; c) Innovative ability, good team collaboration spirit, and strong communication skills; d) Others. 4. Work Experience: More than one year of experience in product design and development and engineering project management. 5. Personal Traits: a) Detail-oriented, highly responsible, and good team cooperation awareness; b) Strong learning ability, interpersonal skills, and communication skills; c) Ability to solve problems independently and proactively; d) Physically healthy. Promotion Direction: Technical R&D Manager.

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2025.01.06

Technical Research and Development Supervisor


Job Description: 1. Develop or introduce new medical products, and formulate relevant documents according to ISO13485 standards; 2. In terms of product design, the responsibilities include (but are not limited to): a) Responsible for the structural design/development of medical device products; b) Selection of materials and equipment; c) Literature/patent research; d) Sample development; e) Research, project initiation, management, application, and external cooperation for scientific research projects; f) Reasonable arrangement and control of resources required for the R&D process. 3. In terms of product manufacturing: product mass production conversion, process improvement, defect analysis, abnormal handling, etc. 4. Complete the recording of the entire product preparation process and laboratory operation records according to the quality system regulations. 5. Other tasks assigned by superiors. Job Requirements: 1. Education Level: Mechanical/Materials/Medical related major, bachelor's degree or above. 2. Knowledge: Certain knowledge of medical device products, medical device system knowledge, and project management knowledge. 3. Skills: a) Proficient in using drawing software such as AUTO CAD, SolidWorks, or Pro-E; b) Proficient in using office software; c) Innovative ability, good team collaboration spirit, and strong communication skills. d) Others. 4. Work Experience: More than three years of experience in product design and development and engineering project management. 5. Personal Traits: a) Serious and meticulous work attitude, high sense of responsibility, and good team cooperation awareness; b) Strong learning ability, interpersonal skills, and communication skills; c) Ability to independently solve problems and take initiative. d) Good physical health.

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2025.01.06

Administrator Representative / Quality Department Manager


Job Description: 1. Organize the establishment and implementation of a quality management system that is compatible with the medical devices produced, and maintain its scientific, reasonable, and effective operation, reporting the operation status and improvement needs of the quality management system to the enterprise leader; 2. Implement relevant laws, regulations, systems, and standards related to medical devices; 3. Develop and organize the implementation of the audit plan for the enterprise's quality management system, assist the enterprise leader in organizing management reviews as planned, prepare audit reports, and report the review results to the enterprise management; 4. Organize internal training on medical device quality management to enhance employees' quality management capabilities and strengthen the enterprise's awareness of integrity and compliance with the law; 5. During inspections by various levels of drug supervision and management departments at the production enterprise, maintain communication with the inspection team, provide relevant information and materials, cooperate with the inspection work, and organize relevant departments of the enterprise to rectify issues found during inspections in a timely manner according to requirements; 6. Formulate the company's quality objectives and their implementation, organize, promote, and implement quality policies and objectives, and supervise and assess the completion of quality objectives by various departments; 7. Responsible for the certification of the company's quality management system, develop plans and lead the quality system assessment. Job Requirements: 1. Associate degree or above, majoring in medical, pharmaceutical, or analytical science and engineering, with more than 5 years of relevant work experience in medical device and consumable enterprises with more than 150 employees, possessing experience in the operation of medical device quality management systems or production and technical management, familiar with relevant medical device products, production, and quality management; 2. Master the ISO 13485 system and the "Regulations on the Quality Management of Medical Device Production" and other relevant laws, regulations, rules, and standards related to medical devices, and have ISO 13485 internal auditor qualifications; 3. Familiar with the quality management work of medical device production, possessing professional skills to guide or supervise various departments of the enterprise in implementing the "Regulations on the Quality Management of Medical Device Production" as required, and the ability to solve practical problems, with experience in receiving regulatory department inspections; 4. Possess good organizational and analytical problem-solving abilities, team collaboration spirit, and a sense of work responsibility.

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