Instrument Industrialization Supervisor/Senior Engineer

岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

负责生物梅里埃有源仪器项目的本地化项目，为现有产品/新工艺提供技术支持或/和改进方案，并主导建立本土化仪器的组装/测试程序，产品的开发验证和支持内部/外部测试等工作，以支持本土仪器的注册和最终商业化生产。
Responsible as internal point of  reference to guaranty bioMerieux active instruments transfer project for localization, to provide technical support and /or improvement to existing products/processes, and lead to setup instruments assembly/testing procedures, validation , and internal/external testing for supporting local registration and final commercial production.  

主要职责 / MAIN ACCOUNTABILITIES

Safety, Health & Environment /安全，健康和安全

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.

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
仪器本土化项目的项目管理和控制。包含但不限于项目计划、风险控制等工作。对接海外转移工厂的技术专家，参与项目组定期会议汇报项目进展。
Instrument localization projects management and control, including but not limited to Project plan management, Risk assessment control ,etc. In contact with sending site SMEs and report project status in regular project meeting.

转移并本地化相关组装和测试程序文件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。
Transfer and localize related assembly and testing procedures to adapt to China local codes or regulations, and meet product technical requirements and local mandatory standards.

主导组装和测试工艺研究和工艺验证, 方案/报告的的撰写和执行。解决仪器组装和测试过程中技术难点。
Lead Instruments assembly & testing process study & process validation  including  protocol/report writing, validation/study execution, etc. Solve technical issues during instruments assembly and testing activities.

主导仪器产品验证包含单不限于子部件验证、系统硬件/固件验证、性能验证等等，方案/报告的的撰写和执行。以支持产品注册所需的研究报告的输出。
Lead instrument product validation including but not limited to components validation, Hardware/Firmware validation, system performance validation, etc. Protocols and reports writing and execution to support product registration.

基于项目需求支持仪器的型式检验或其他验证/确认等工作。
Support instrument type testing or other qualification/verification activities per project required .

支持注册资料的撰写和整理。
Support registration dossiers writing and preparation.

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
Supports site, corporate and competent authority quality system audit activities of GMP and ISO 13485 etc.

必要的苏州工厂出差（每月20%左右）
Necessary business trips to Suzhou factory (about 20% per month)
Routine Operation/常规运营

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。
Keep optimization process related procedures to adapt to China local codes or regulations, , and meet product technical requirements and local mandatory standards.

解决仪器组装和测试过程中技术难点。
Solve technical issues during instruments assembly and testing activities.

产品变更验证如产品组件本土化转换验证、产品设计变更（硬件和软件等）验证等。
Perform validation to support Instrument change , for instance, components localization validation, instrument design change (hardware and software) validation, etc.

基于需求支持仪器的定期验证/确认等工作。
Support instrument periodical qualification/verification activities per required .

主导工艺风险分析和定期回顾
Lead process risk analysis (e.g. pFMEA) and review timely.

质量事件和变更控制等并作为技术专家给与评估，并执行分配的任务。
Provide technical evaluation to support QE investigation and change control management , and to perform assigned tasks in time.

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

本科及以上学历，机械，电子，生物工程、医学工程等医疗器械相关专业，需要有至少3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, bioengineering, medical engineering, etc. and necessary to have at least 2 years of relevant work experience in active medical device R&D or production companies
语言技能：英语和中文听、说、读、写熟练，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 skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese, applicants with working experience in European and American foreign-funded enterprises will be given priority, Proficient in operating 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研发和产品验证经验者优先。
It will be given priority that candidate who  has rich experience in instrument product development and product verification.
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