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更新于 11月4日
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安規(guī)工程師/測試工程師

1-1.5萬
  • 無錫新吳區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

安規(guī)測試電氣安全電子兼容
In this role, you will be responsible for GE Healthcare anesthesia machine safety qualification &
regulatory certification. As this role, you need to provide the input to engineering/program
team with clarification, training and guidance if necessary. Guide and support relative
verification test engineers to performing safety standards compliance testing. Coordinate with
3
rd party laboratories to perform the test due to the requirements of the IEC 60601-1, GB9706.1
series and other relevant standards, and obtain the certification report from notify body for GE
Healthcare anesthesia machine.
Key Responsibilities
? Stay on current relevant Standards and assess the impacts of the changes with SRB.
? Provide the input to engineering/program team with clarification, training and guidance
to engineering/program team regarding safety standard requirements.
? Define test input requirements (PTR), work with engineering/program team and testing
laboratory in completing appropriate test activities as well as obtain the test report.
? Take responsibility for the safety test plans and reports.
? Interface with internal engineering /program team and external testing laboratories
(TUV, Intertek, CMTC i.e.) in arranging and conducting testing.
? Clarify internal customer’s facility and test needs to assure laboratory meets internal
customer’s and external testing laboratory's requirements.
? Support the engineering/program DCP activities, as well as internal/FDA (Mock)/NMPA
QMS i.e. audit.
? Support (NMPA, MDR, 510K) registration and other regulation relating activities (CCN).Required Qualifications:
? Bachelor or Master degree with major in Electrical engineering, Automation
engineering, Information Engineering or Telecommunications engineering, etc.
? 3 years or above of relevant working experience is preferred.
? Knowledge of Anesthesia Respiratory, and work experience in medical device (active,
class Ⅱ/Ⅲ) research and development is preferred.
? Demonstrated capability to pursue tasks completion, problem solving and results
orientation, ownership spirit as well as multi-task management ability.
? Knowledge of Quality Management Systems for the medical device industry
? Knowledge of the ISO18562/IEC60601/GB 9706.1 standards for medical device (active,
class Ⅱ/Ⅲ).
? Experience working for/with safety testing laboratories (TUV, Intertek, CMTC i.e.)
? Good teamwork spirit in a multi-site working culture, energizing, positive and self
motivation.
? Smart personality and communication skills are preferable.
? Good English skills in reading, writing and speaking.

工作地點(diǎn)

無錫新吳區(qū)通用電氣醫(yī)療系統(tǒng)有限公司

職位發(fā)布者

謝曉冬/人事經(jīng)理

三日內(nèi)活躍
立即溝通
華信永益(北京)信息技術(shù)有限公司
華信永益創(chuàng)建于享有中國硅谷美譽(yù)的北京中關(guān)村，公司凝聚了擁有理想與智慧的IT行業(yè)精英人才，專門從事應(yīng)用軟件開發(fā)、軟件外包、信息系統(tǒng)集成、互聯(lián)網(wǎng)技術(shù)與應(yīng)用開發(fā)的高科技企業(yè)。我們致力于為各行業(yè)客戶提供完美的解決方案，共同打造一家“懂得需求落地、力求完美體驗(yàn)”的公司。我們致力于追求客戶利益最大化、追求優(yōu)質(zhì)滿意的服務(wù)、追求可持續(xù)發(fā)展的戰(zhàn)略方針、追求以人為本的生存之道，致力于為我們的客戶提供完美的解決方案和一流的IT服務(wù)。華信永益公司高管團(tuán)隊(duì)來聯(lián)想集團(tuán)、中軟集團(tuán)和東軟集團(tuán)高級(jí)管理職位，擁有豐富的經(jīng)營和管理經(jīng)驗(yàn)，技術(shù)負(fù)責(zé)人曾任亞信、用友等公司的CTO，是美國PMI協(xié)會(huì)PMP會(huì)員、高級(jí)信息項(xiàng)目管理師，中國系統(tǒng)與軟件過程改進(jìn)協(xié)會(huì)主任專家會(huì)員，擁有著豐富的技術(shù)和項(xiàng)目管理經(jīng)驗(yàn)。
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