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(xiàn)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(fā)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(fā)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(fā)階段的風險管理工作經(jīng)驗, 醫(yī)療產品研發(fā)經(jīng)驗優(yōu)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(jīng)驗;
Familiar with the ISO14971.
熟悉ISO14971;
Excellent communication skills with colleagues.
良好的溝通能力。
企業(yè)介紹
新瑞陽光粒子醫(yī)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(chuàng)建,并獲得美元基金的巨額投資和無錫當?shù)卣拇罅χС郑瑢W⒂谛乱淮跋褚龑Х暖熝b置的開發(fā)、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(zhàn)癌癥,造福患者的精英加盟,共同打造中國創(chuàng)造的頂尖放療裝置,為癌癥患者帶來新的陽光!