工业化工程师 (仪器)

• 岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB 负责新研发项目从产品设计到工业化生产的转换，推动设计转移及生产工艺、组装和测试程序的建立，支持产品顺利导入量产；同时为现有产品及工艺提供技术支持和改进方案，解决生产过程中的技术问题，持续提升产品质量和制造效率。 Responsible for the transition of new R&D projects from product design to industrial manufacturing, driving design transfer and the establishment of manufacturing processes, assembly procedures, and testing procedures to support successful production launch. Provide technical support and improvement solutions for existing products and processes, resolve technical issues during production, and continuously improve product quality and manufacturing efficiency 2. 主要职责 / MAIN ACCOUNTABILITIES Safety, Health & Environment /安全，健康和环境  确保符合总部EHS方针、本地法规以及ISO14000的需求。 Ensure compliant to global EHS policy, local regulation and ISO 14000 requirements.  学习、掌握并执行国家、政府职能部门、地方的HSE法律法规要求、标准，履行法规要求的HSE责任和义务。 Learn, master and follow HSE laws, regulations, requirements and standards of the country, government functional departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.  严格遵守公司HSE规章制度，服从公司的HSE管理，并执行本岗位的HSE管理要求，承诺“不伤害自己、不伤害他人、不被他人伤害，保护他人不受伤害“的四不伤害员工职责。 对被赋予的工作活动做好危害辨识、风险评估、应急预案并确保执行安全操作规范。有责任及时汇报HSE隐患及事故。 Strictly comply with HSE rules and regulations, and implement the HSE management requirements of this position. Promise to follow the requirement ＂do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm＂. Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely. Quality and Regulation/质量和法规  确保遵守国家药品监督管理局相关法规、ISO 13485 标准以及其他适用行业规范，以支持完成公司目标。 Support the company’s goal of ensuring compliance with NMPA regulations, ISO 13485 standard and other industry codes applicable. Project /项目  项目管理：负责有源医疗设备从研发向生产转移的工业化转产项目工作，包含但不限于项目计划、风险控制等工作。对接上下游，参与项目组定期会议汇报项目进展。 Project Management: Manage industrialization transfer projects for active medical devices from R&D to production, including but not limited to project planning and risk control. Coordinate with upstream and downstream stakeholders and report project progress at regular project team meetings.  设计转换和工艺建立：组织或参与研发转移资料的完整性和可制造性评审，将研发输出的图纸、物料清单、规格、工艺流程和检验要求等转化为受控组装和测试程序文件、标准操作程序、工艺风险分析pFMEA等以适应中国当地的规范、法规，并符合产品技术要求和本地强制性标准。 Design Transfer and Process Establishment: Organize or participate in reviews of R&D transfer documentation for completeness and manufacturability. Translate R&D outputs, including drawings, bills of materials, specifications, process flows, and inspection requirements, into controlled assembly and testing procedures, standard operating procedures, and process risk analyses such as pFMEA, to meet applicable local codes and regulations in China, product technical requirements, and local mandatory standards.  中试生产和工艺验证：组织中试和规模化试生产,主导工艺研究和工艺验证，方案/报告的的撰写和执行；完成相关培训；联合研发和生产解决中试验证中的工艺技术难点；负责新项目首版工装设计及导入等工作 Pilot Production and Process Validation: Organize pilot production and scale-up trial production. Lead process studies and process validation, including the preparation and execution of protocols and reports, and complete related training. Work with R&D and Production to resolve process-related technical challenges during pilot production and validation. Design and introduce the initial tooling and fixtures for new projects.  技术研究： 包含但不限于以下内容：将研发确定的产品参数转化为量产过程中的控制要求；关键原料和关键工艺的定义和可追溯性； 仪器和试剂的适配性能研究等等。 Technical Studies: Activities include, but are not limited to, translating product parameters defined by R&D into control requirements for mass production; defining critical raw materials and critical processes and establishing their traceability; and studying instrument–reagent compatibility and performance.  注册支持：提供注册检验所需的受控样品和工业化研究资料，支持必要的型式检验或其他验证/确认等工作 Registration Support: Provide controlled samples and industrialization study documentation required for registration testing, and support necessary type testing and other verification or validation activities.  审计活动：支持工厂、集团质量以及监管当局的良好生产规范和ISO 9001/ISO 13485质量体系等审核活动 Audit Activities: Support audits conducted by the site, Group Quality, and regulatory authorities covering Good Manufacturing Practice and quality management systems such as ISO 9001 and ISO 13485.

Routine

Operation/常规运营  工艺优化：不断优化工艺相关程序以适应中国当地的规范或法规, 并符合产品技术要求和本地强制性标准。 Process Optimization: Continuously optimize process-related procedures to meet applicable local codes or regulations in China, product technical requirements, and local mandatory standards.  技术处理：解决仪器组装和测试过程中技术难点；支持客户投诉中涉及产品技术原因的问题分析 Technical Troubleshooting: Resolve technical challenges during instrument assembly and testing, and support the analysis of product-related technical causes of customer complaints.  变更管理：产品变更验证如涉及重大工艺变更、产品设计变更（非关键性）验证等。 Change Management: Perform verification or validation of product changes, including major manufacturing process changes and non-critical product design changes.  风险控制：主导工艺风险分析和定期回顾 Risk Control: Lead process risk analyses and periodic reviews.  质量事件：质量事件作为技术专家给与评估，并执行分配的任务。 Quality Events: Provide assessments of quality events as a technical expert and carry out assigned tasks. 职位要求： 3. 知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE  本科及以上学历，机械，电子，通讯等相关专业，需要有至少5年以上的有源医疗器械研发或生产企业相关工作经验。 Bachelor degree or above, major in active medical devices such as mechanics, electronics, communications engineering, etc. and necessary to have at least 5 years of relevant work experience in active medical device R&D or production companies  语言技能：具备一定的英语和中文听、说、读、写能力，有欧美外资企业工作经验者优先。熟练操作Word和Excel等办公软件。 Language and Computer Skills: Working knowledge of English and Chinese in listening, speaking, reading, and writing.

Experience working for European or American foreign-invested companies is preferred. Proficiency in office software such as Word and Excel.  了解医疗仪器产品注册法规，了解仪器产品型式检验者优先。 It will be given priority that knowing about Medical Instrument type testing and medical instrument registration regulatory  良好的机械、电子电路故障解决能力者优先, 对仪器组装和测试有一定的动手操作能力。 It will be given priority that good capability to solve mechanical/ electronic circuit issues, and have practical operation ability for instrument assembly and testing.  具备丰富的仪器产品转产和产品验证经验者优先。 It will be given priority that candidate who has rich experience in instrument product technical transfer and product verification field.  有良好的团队合作能力。 Good Interpersonal skill and team player.  熟悉ISO 19001, ISO 13485, ISO 14971, GMP等医疗器械及生物安全等相关的法规规范者优先。 Be familiar with relative medical device regulation and bio-security and other codes, such as ISO 19001, ISO 13485, ISO 14971 and GMP ，will be given priority