職位描述
職責描述：
Lead and implement the risk management activities of the medical product according to the regulation ISO14971 during the whole product lifecycle.
領導團隊實現在整個產品周期內的符合ISO14971的風險管理活動；
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.
領導、組織相關各個部門產品的風險識別、分析（以用戶對產品的使用、操作對出發點進行分析；
Lead and organize the clinical engineer, product engineer, system engineer to do and finish the risk estimation, risk uation.
領導、組織團隊進行并完成風險評估；
Lead and organize the design the development engineers to do the risk control of the product.
領導、組織開發工程師進行風險控制；
Generating and maintain the risk management files in the product lifecycle.
建立、維護風險管理文檔；
Do the residual risk management when system is updated
進行必要時候的剩余風險管理活動；
Lead the whole verification of the risk control measures and ensure the product risk is control and accepted.
領導風險控制的整個驗證活動，以保證產品的風險可控并可接受；
Other tasks assigned by the leader.
其它未盡事宜。
任職要求：
With the risk management experience in product, Master design the development. Medical product R&D experience is better.
有產品設計開發階段的風險管理工作經驗, 醫療產品研發經驗優先；
Experiences with leading a group to finish a task.
有領導團隊完成獨立完成任務的經驗；
Familiar with the ISO14971.
熟悉ISO14971；
Excellent communication skills with colleagues.
良好的溝通能力。
企業介紹
新瑞陽光粒子醫療裝備（無錫）有限公司是總部位于美國加州硅谷的NewRT Medical Systems, Inc.在中國的全資子公司。公司由一批來自全球頂尖放療設備廠商Varian, IBA, 美國著名大學和國家實驗室的高級專家和高級技術管理人員創建，并獲得美元基金的巨額投資和無錫當地政府的大力支持，專注于新一代影像引導放療裝置的開發、生產和銷售，立志打造世界水平的國產化先進放療裝置。
公司誠邀有志于挑戰癌癥，造福患者的精英加盟，共同打造中國創造的頂尖放療裝置，為癌癥患者帶來新的陽光！
