职责描述：
Lead and implement the risk management activities of the medical product according to the regulation ISO14971 during the whole product lifecycle.
领导团队实现在整个产品周期内的符合ISO14971的风险管理活动；
Lead and organize the cross-functional department to do the product risk analysis mainly based on clinical user, patient and system user, Master operation of our product.
领导、组织相关各个部门产品的风险识别、分析（以用户对产品的使用、操作对出发点进行分析；
Lead and organize the clinical engineer, product engineer, system engineer to do and finish the risk estimation, risk uation.
领导、组织团队进行并完成风险评估；
Lead and organize the design the development engineers to do the risk control of the product.
领导、组织开发工程师进行风险控制；
Generating and maintain the risk management files in the product lifecycle.
建立、维护风险管理文档；
Do the residual risk management when system is updated
进行必要时候的剩余风险管理活动；
Lead the whole verification of the risk control measures and ensure the product risk is control and accepted.
领导风险控制的整个验证活动，以保证产品的风险可控并可接受；
Other tasks assigned by the leader.
其它未尽事宜。

任职要求：
With the risk management experience in product, Master design the development. Medical product R&D experience is better.
有产品设计开发阶段的风险管理工作经验, 医疗产品研发经验优先；
Experiences with leading a group to finish a task.
有领导团队完成独立完成任务的经验；
Familiar with the ISO14971.
熟悉ISO14971；
Excellent communication skills with colleagues.
良好的沟通能力。

新瑞阳光粒子医疗装备（无锡）有限公司是总部位于美国加州硅谷的NewRT Medical Systems, Inc.在中国的全资子公司。公司由一批来自全球顶尖放疗设备厂商Varian, IBA, 美国著名大学和国家实验室的高级专家和高级技术管理人员创建，并获得美元基金的巨额投资和无锡当地政府的大力支持，专注于新一代影像引导放疗装置的开发、生产和销售，立志打造世界水平的国产化先进放疗装置。

公司诚邀有志于挑战癌症，造福患者的精英加盟，共同打造中国创造的顶尖放疗装置，为癌症患者带来新的阳光！