Principal System Engineer, Fluid Systems (职位编号:Baxter001012)
苏州百特医疗用品有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-03-23
- 工作地点:苏州
- 招聘人数:1人
- 学历要求:本科
- 职位月薪:1-2万/月
- 职位类别:医疗器械研发
职位描述
岗位职责:
? Interact with customers and marketing to develop and refine user requirements.
? Communicate design requirements and provide technical guidance to suppliers as needed.
? Ensure user needs are captured, quality requirements are met and technical risks are mitigated
? Lead the development and documentation of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
? Develop the Risk Management Plan and execute the Risk Management activities defined by the plan.
? Manage integration of deliverables from sub-system design teams and external partners.
? Resolve competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, and marketing, etc.) required to deliver the product to market.
? Plan and execute system integration activities to minimize issues in systems validation.
? Develop test plans, test protocols, and test reports for product integration testing.
? Document traceability from requirements to verification activities, and from requirements to design entities.
? Resolve systems-related technical issues by applying problem solving tools such as FMEA, DOE, cause and effect diagrams, Pareto charts, etc.
? Develop and maintain an effective and corroborative working relationship with internal and external development partners.
? Provide leadership to effectively transition the product to manufacturing and ensure robust products and manufacturing processes.
任职资格:
? Requires strong organization, communication and technical writing skills, with the ability to interface with both technical and non-technical personnel, in multiple sites around the world…
? Experience with requirements management tools, design control requirements (21CFR 820.30, ISO 13485), risk management (ISO 14971) desired.
? Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
? Able to develop plans, schedules and support cross-functional team throughout detailed phases of the engineering work in a project
? Manage integration of deliverables from sub-system/functional design teams
? Understands medical device product development, and is very familiar with design controls process
? Design Inputs (Requirements management), Design Outputs, Verification and Validation as well as Risk Management
? Work with cross functional team members (e.g. Marketing and Clinical personnel) to convey user needs into system requirements
? Supports functional engineering resources (Electrical, Mechanical, Software and Test) in the decomposition of system requirements to derived subsystem requirements and test.
? Mandarin and English fluency required
? B.S. Or M.S. Degree or Equivalent External Experience
? Major in Mechanical engineering or other relevant education background.
? Experience should include at least 5-8 years of relevant technical experience, including some technical leadership
? Experience with or knowledge of plastic and metal part design, manufacturing and processing procedures
? Knowledge of DFM (Design for Manufacturing) and DFS (Design for Service)
? Understanding of materials, components and engineering technology
职能类别: 医疗器械研发
公司介绍
每一天,百特影响着数以百万计的生命,我们凭借必要的医院和肾科产品与服务应对重大健康需求。在全球,几乎每个医院的每个科室,乃至每一楼层,都能发现百特产品与疗法的身影。同时,百特也出现在诊所和患者家中。
Every day, Millions of lives relay on Baxter, Our products and service are essential building blocks of healthcare. Baxter products and treatment are found almost in everyplace, in every hospital at every Department even on every floor. Meanwhile, Baxter is there, not only the clinic but also our patient home.
百特于上世纪80年代来到中国,是***进入中国医疗市场的大型跨国医疗企业之一。秉承“拯救并延续生命”的企业使命,百特专注于协助提升医疗标准、扩大医疗可及性和回馈社会等关键性工作,为中国患者的生命和生活质量做出有意义的贡献,助力中国医疗事业的可持续发展。
In the 80s Baxter has come to China which is one of the earliest multinational medical enterprise, Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations, also delivering contribution to our patient and their Quality lives meanwhile it will be supportive of sustainable development for Chinese medical treatment cause
苏州百特医疗用品有限公司成立于1995年, 是百特在中国建立的***家独资工厂,主要生产静脉输液袋、腹膜透析袋及相关组件,以用于静脉输注及腹膜透析治疗。我们始终严格执行中国质量管理体系,确保我们的产品以***质量和安全标准为患者及医护人员服务。目前, 560多名员工正运用最创新和先进的制造技术,为中国大陆、中国台湾、新加坡、澳大利亚、菲律宾及泰国等国家和地区的客户提供优质高效的医疗产品,为依赖于百特产品的患者带去有意义的改变。
Suzhou Baxter healthcare co., LTD is founded in 1995, This is the first sole plant in China. Baxter Suzhou produced venous transfusion container, PD bag and other related components which used in PD and venoclysis treatment, In order to provide the high-quality product, and let our customers using safety. Baxter Suzhou not only follow up the quality policy of Baxter headquarters, but also carry out the quality management system of China strictly as well ,At present, more than 560 employees are using the latest manufacturing technology to provide high quality medical products for customers comes from China Taiwan, India, Australia and the Philippines.
我们的理念是注重结果、客户导向;我们的价值观是正直诚实、坦诚沟通、承责力行;我们的激励方式是鼓励创新、奖励优秀。百特致力于成为危重治疗领域的领先企业,期盼更多优秀人才的加入,我们承诺为您提供充满活力的工作和成长环境,与百特共筑未来!
联系方式
- 公司地址:百特天津工厂