職位描述
職責(zé)描述:
Lead and implement the risk management activities of the medical product according to the regulation ISO14971 during the whole product lifecycle.
領(lǐng)導(dǎo)團(tuán)隊實現(xiàn)在整個產(chǎn)品周期內(nèi)的符合ISO14971的風(fēng)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(lǐng)導(dǎo)、組織相關(guān)各個部門產(chǎn)品的風(fēng)險識別、分析(以用戶對產(chǎn)品的使用、操作對出發(fā)點進(jìn)行分析;
Lead and organize the clinical engineer, product engineer, system engineer to do and finish the risk estimation, risk uation.
領(lǐng)導(dǎo)、組織團(tuán)隊進(jìn)行并完成風(fēng)險評估;
Lead and organize the design the development engineers to do the risk control of the product.
領(lǐng)導(dǎo)、組織開發(fā)工程師進(jìn)行風(fēng)險控制;
Generating and maintain the risk management files in the product lifecycle.
建立、維護(hù)風(fēng)險管理文檔;
Do the residual risk management when system is updated
進(jìn)行必要時候的剩余風(fēng)險管理活動;
Lead the whole verification of the risk control measures and ensure the product risk is control and accepted.
領(lǐng)導(dǎo)風(fēng)險控制的整個驗證活動,以保證產(chǎn)品的風(fēng)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(chǎn)品設(shè)計開發(fā)階段的風(fēng)險管理工作經(jīng)驗, 醫(yī)療產(chǎn)品研發(fā)經(jīng)驗優(yōu)先;
Experiences with leading a group to finish a task.
有領(lǐng)導(dǎo)團(tuán)隊完成獨立完成任務(wù)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(shè)備廠商Varian, IBA, 美國著名大學(xué)和國家實驗室的高級專家和高級技術(shù)管理人員創(chuàng)建,并獲得美元基金的巨額投資和無錫當(dāng)?shù)卣拇罅χС?,專注于新一代影像引?dǎo)放療裝置的開發(fā)、生產(chǎn)和銷售,立志打造世界水平的國產(chǎn)化先進(jìn)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!