Industrialization Engineer

2 weeks ago


Suzhou, Jiangsu, China bioMerieux SA Career Site - MULTI-LINGUAL Full time

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



  • Suzhou, Jiangsu, China Philips Full time

    Job TitleProduct Industrialization Engineer-IGTSJob DescriptionAs a Product Industrialization Engineer within Image Guided Therapy Systems you design, change and implement a high quality, high performing production line for Medical X-ray Devices in a low volume industry. You will be working in a cross functional, global team with different...


  • Suzhou, Jiangsu, China Philips Full time

    Job TitleAdvanced Mechanical EngineerJob DescriptionJob title:Advanced Mechanical Engineer- MR Purpose:You are responsible for designing and developing detailed mechanical parts for coils, including the whole system coil housing, coil connection. Principal Accountabilities: Design and develop detailed mechanical designs for MRI RF coils to full product...


  • Suzhou, Jiangsu, China Philips Full time

    Job Title2024校招 GDP in Manufacturing EngineeringJob DescriptionJob title:24校招 GDP in Manufacturing EngineeringYour role:Drive Operation Productivity improvement byLean Manufacturing, Operation Excellence, Smart Manufacturing in advanced medical systemDrive strategic and breakthrough project to improve Operation ProductivityYou're the right fit...

  • PAD Engineer

    3 weeks ago


    Suzhou, Jiangsu, China Lyondell Basell North America Full time

    PAD EngineerBasic FunctionProduct and Application Development (PAD) engineer works on development of polypropylene compounds products used in automotive, electronic appliance, consumer and industrial applications. He/she is requested to work under supervisory of PAD Manager on product development and innovation projects to fulfill market trends, customer...

  • product engineer ii

    3 weeks ago


    Suzhou, Jiangsu, China TE Connectivity Full time

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Product Engineering Teams optimize existing products from information or input provided by marketing, customers, Operation Teams, Development Engineers or other employees....


  • Suzhou, Jiangsu, China Philips Full time

    Job TitleSenior Mechanical Engineer- MR CoilJob DescriptionJob title: Senior Mechanical Engineer- MR CoilYour role:You are responsible for designing and developing detailed mechanical parts for coils, including the whole system coil housing, coil connection. Principal Accountabilities:Design and develop detailed mechanical designs for MRI RF coils to full...

  • PPC PAD Engineer

    7 days ago


    Suzhou, Jiangsu, China Lyondell Basell North America Full time

    PPC PAD EngineerBasic FunctionProduct and Application Development (PAD) engineer works on development of polypropylene compounds products used in automotive, electronic appliance, consumer and industrial applications. He/she is requested to work under supervisory of PAD Manager on product development and innovation projects to fulfill market trends, customer...

  • PPC PAD Engineer

    2 weeks ago


    Suzhou, Jiangsu, China Lyondell Basell North America Full time

    PPC PAD EngineerBasic FunctionProduct and Application Development (PAD) engineer works on development of polypropylene compounds products used in automotive, electronic appliance, consumer and industrial applications. He/she is requested to work under supervisory of PAD Manager on product development and innovation projects to fulfill market trends, customer...


  • Suzhou, Jiangsu, China TE Connectivity Full time

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Manufacturing Engineering Teams are process leaders for stamping, molding or assembly related topics, ensuring the processes are running at optimum levels for quality and...


  • Suzhou, Jiangsu, China TE Connectivity Full time

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Manufacturing Engineering Teams are process leaders for stamping, molding or assembly related topics, ensuring the processes are running at optimum levels for quality and...


  • Suzhou, Jiangsu, China Grundfos Full time

    Would you like to take regional responsibility for coordinating all aspects of large-scale and challenging SBTi projects? And as part of a company that cares about our environment and its employees?Then this is your chance to join us as Senior Product Development EngineerWhat is the job about? Contribute to the Scrum Team's deliveries by applying Engineering...

  • RF Coil Engineer

    1 week ago


    Suzhou, Jiangsu, China Philips Full time

    Job TitleRF Coil EngineerJob DescriptionJob title:The company is currently seeking to recruit an RF Coil engineer to join the RF Coil R&D team. The position will play an important role in the development of new concept or product coil designs adding to the portfolio of RF Coil products. The post will suit an engineer ideally familiar with MRI RF Coil...

  • EP PAD Engineer

    2 weeks ago


    Suzhou, Jiangsu, China Lyondell Basell North America Full time

    EP PAD EngineerBasic FunctionProduct and Application Development (PAD) engineer works on development of flame retardant polymer products used in NEV three-electric system("Three ES", battery, motor, and electronic control), Connectors, electronic appliance, consumer and industrial applications. He/she is requested to work under supervisory of PAD Manager on...


  • Suzhou, Jiangsu, China Philips Full time

    Job TitleSystem Integration EngineerJob DescriptionIn this role, you have the opportunity toSystems Integration Engineers deliver high quality products, by meeting user and business needs, managing complexity, technical leadership, and stakeholder management.Overall technical leadership and responsible for realization of full systems product release/life...


  • Suzhou, Jiangsu, China Philips Full time

    In this role, you have the opportunity toSystems Integration Engineers deliver high quality products, by meeting user and business needs, managing complexity, technical leadership, and stakeholder management.Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance....

  • ME Engineer

    4 weeks ago


    Suzhou, Jiangsu, China Grundfos Full time

    What is the job about?Support production line to maintain and improve process/OPR/productivity/safety Your main responsibilities:Create correct P/N, BOM for product in SAP system. Make and maintain process documentations (Flow chart/PFMEA/Work instruction/Control instruction), and implement training Introduce new chemicals and MSDS with chemical assessment...


  • Suzhou, Jiangsu, China TE Connectivity Full time

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Manufacturing Engineering Teams are process leaders for stamping, molding or assembly related topics, ensuring the processes are running at optimum levels for quality and...


  • Suzhou, Jiangsu, China TE Connectivity Full time

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job OverviewTE Connectivity's Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established...


  • Suzhou, Jiangsu, China Danaher Corporation Full time

    The Sr. Sourcing Engineer is responsible for developing and executing optimal commodity & sourcing strategies. Establish & enhance Supplier relationships to drive sourcing & supplier initiatives to meet or exceed product quality, service & deliver sustainable cost reductions, whilst reducing or mitigating risk in the Supply Chain.Responsibilities:1,...


  • Suzhou, Jiangsu, China Philips Full time

    Job TitleSenior Gradient Coil Mechanical EngineerJob DescriptionJob title:Senior Mechanical Engineer-MRPURPOSE:We are seeking a talented and experienced MRI Gradient coil Mechanical Engineer to join our team. If you are passionate about cutting-edge technology and eager to contribute to the advancement of medical science, we want to hear from you.1.Principal...