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Your responsibilities include:
?Be responsible for Active medical equipment
?負(fù)責(zé)有源醫(yī)療設(shè)備或有源耗材的相關(guān)工作
?Create medical device DHF and registration materials including the PTR
?生成醫(yī)療設(shè)備的設(shè)計(jì)歷史文件與注冊資料，包括產(chǎn)品技術(shù)要求
?Support type testing including GB9706.1 safety and YY0505 EMC and GB/T 14710 Environmental test
?支持型檢，包括GB9706.1安全測試， YY0505 EMC測試與 GB/T 14710環(huán)境測試
?Create BOM/Finished Good documents
?生成BOM/Finished Good documents
?Design the verification test method, do test method validation and test fixture qualification
?設(shè)計(jì)驗(yàn)證的測試方法，驗(yàn)證測試方法以及確認(rèn)測試工裝夾具
?Attend the design review meeting
?參加設(shè)計(jì)評審會議
?Analyze the design change
?分析設(shè)計(jì)變更
?Execute design verification
?執(zhí)行設(shè)計(jì)驗(yàn)證測試
?Create test plan, test protocol. Execute the test and generate test report
?制定測試計(jì)劃，測試方案，執(zhí)行測試活動(dòng)并生成測試報(bào)告
?Support design transfer including manufacture line set up
?支持設(shè)計(jì)轉(zhuǎn)移包括產(chǎn)線搭建
?Support Labeling design
?支持標(biāo)簽設(shè)計(jì)
?Support packaging design
?支持包裝設(shè)計(jì)
?Support deficiency letter and NMPA on-site audit
?支持注冊發(fā)補(bǔ)單回復(fù)及NMPA現(xiàn)場審查
?Set up test environment.
?搭建測試環(huán)境
?Coordinate and collaborate with global team members
?與國外團(tuán)隊(duì)合作共同完成項(xiàng)目
?Collaboration with multi divisions on domain technology transfer and acceptance definition
?Work with all stakeholders to translate user needs into design requirements, create system requirements and other associated subsystem requirements
?Lead conception, system architecture and accomplish design of new or new generation technologies/products
?Analyze system requirements, generate master validation plan and conduct DV&Vs, not limited to system tests characterization tests, functional tests and standard based tests
?Design and execute engineering studies to characterize performance, demonstrate safety, efficacy and compliance with relevant requirements and standards
?Work with Quality, Operation and manufacturer for introduction of new products, provide assist during line set-up
?Development of test scenarios following design and requirement documents to ensure intended behavior is verified
?Interact with SW developers, Systems engineers, project management, and other Quality team members to identify, report, and troubleshoot defects in a detailed, efficient, and timely manner
?Maintain, report test results and investigate test failures
?Focus on product quality
What we’re looking for:
?本科以上工程背景
?本科以上3年工作經(jīng)驗(yàn)
?有源醫(yī)療設(shè)備/耗材經(jīng)驗(yàn)
?有團(tuán)隊(duì)精神，容易合作
?有獨(dú)立工作能力，善于解決問題
?有醫(yī)療行業(yè)經(jīng)驗(yàn)更好
?英語能基本聽說