上海相关职位: 口腔医学学术专员 医疗器械大客户经理 动物实验技术员 产品经理(慢病业务线) 资深检测师(农药残留测试领域) 地区经理(OTC) 生信报告专员 微生物药物安全性评价 微生物制剂工艺研发员 学术推广
周边城市招聘: 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期: 2017-11-09
5-7年经验
本科
招1人
12-06 发布
职位描述: 1) Main tasks:1.Transfer marketing product requirements and regulatory standard into technical requirements, design and document the system architecture, including review and alignment with key stakeholders2.Develop technical solution for specific requirements or features, lead the implementation of possible technical solutions and evaluate them with reasonable Matrix methodologies.3.Coordinate the development activities among different functions (R&D, Verification, R&A, purchase, etc.), such as design review, system integration, project planning and so on.4.Be one of the Cross Functional Team members within the R&D projects, provide routine status to project team and get the feedback5.Support relevant product registration activities and provide help as necessary2) Secondary tasks:1.Build up system know how on dialysis machines and the application development and provide it to other functions in the organization, including solid technological know-how, setup and maintenance, and medical scientific background2.Develop innovative ideas to fulfil the unmet needs from the market3.Assure compliance to corporate policies and local standards operating procedures as well as domestic and international standards3) Miscellaneous tasks:Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work.1.Other tasks assigned by the supervisor1) Required training and education:Master degree or above in engineering or science; or Bachelor’s with equivalent plus more than 6 years product life cycle experience with demonstrated results to do system design of complex professional instrument, medical device will be a plus2) Required professional experience (in years):1.6 years or more related experience in Medical device industry3) Important personal qualities:1.Able to work with people with different cultural and education background2.Self-Initiative and able to work under certain pressure3.Good communication skills4.Team work spirits4) Other specialized knowledge:a) Technical knowledge1.Proven education regarding Master or Bachelor in Systems, Mechanical, Electrical, Computer Science, Physics or Biomedical Engineering2.Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, bothdomestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, CFDA3.Demonstrated experience in product development for complex professional instrument. Medical device is preferred.4.Capability of System Modelling simulation5.Demonstrated experience in product requirements break-down into systems, subsystems, modules and/or cross functions.6.Demonstrated expertise in applying DFx (manufacturability, assembly, serviceability, safety, cost) knowledge to system & sub-systems designs in mechanical, electronics, software/firmware.b) Languages1.Good written and verbal communication skills in Englishc) IT skills1.Good word, excel and PPT tool2.Skills in product requirement management tools, like DOORs, Polarion, etcd) Product knowledge1.Experience in Medical device development and relevant regulatory standard, system architecture, working principle, safety design, etc2.Experience in other professional diagnosis instrument and relevant regulatory standard, system architecture, working principle, safety design, etc3.Good understand of the operation environment of the product being developed and its market situation5 ) Special personal requirements:1.Excellent communication and documentation skills2.Excellent ethic with strong ability to work with cross functional/sites teams3.Being self-initiative and have strong sense of product quality and responsibilities4.Good English skills both in verbal and writing5.Being flexible for abroad training and travelling6.Being innovative and open to the new technologies 职能类别: 医疗器械研发
田林路1036号科技绿洲三期15号楼
费森尤斯集团作为世界五百强企业之一,是全球性的医疗保健服务公司。公司以优质的医疗产品和可信赖的治疗服务享誉全球。费森尤斯研发中心,涵盖研发、知识产权、质量管理、注册、工程等部门,汇集全球研发精英。公司提供具有竞争力的薪资,出国培训计划。
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上海相关职位: 口腔医学学术专员 医疗器械大客户经理 动物实验技术员 产品经理(慢病业务线) 资深检测师(农药残留测试领域) 地区经理(OTC) 生信报告专员 微生物药物安全性评价 微生物制剂工艺研发员 学术推广
周边城市招聘: 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期: 2017-11-09
