雇員點評標簽
職位描述
有源醫(yī)療器械質量體系管理新產品導入產品本地化生產流程驗證
R&D Engineer
推薦搜索關鍵字：Verification Engineer (驗證工程師)， Product Location (產品本地化)， NPI (新產品導入)
Your responsibilities include:
? Be responsible for Active medical equipment
? 負責有源醫(yī)療設備或有源耗材的相關工作
? Create medical device DHF and registration materials including the PTR
? 生成醫(yī)療設備的設計歷史文件與注冊資料，包括產品技術要求
? 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
? 設計驗證的測試方法，驗證測試方法以及確認測試工裝夾具
? Attend the design review meeting
? 參加設計評審會議
? Analyze the design change
? 分析設計變更
? Execute design verification
? 執(zhí)行設計驗證測試
? Create test plan, test protocol. Execute the test and generate test report
? 制定測試計劃，測試方案，執(zhí)行測試活動并生成測試報告
? Support design transfer including manufacture line set up
? 支持設計轉移包括產線搭建
? Support Labeling design
? 支持標簽設計
? Support packaging design
? 支持包裝設計
? Support deficiency letter and NMPA on-site audit
? 支持注冊發(fā)補單回復及NMPA現(xiàn)場審查
? Set up test environment.
? 搭建測試環(huán)境
? Coordinate and collaborate with global team members
? 與國外團隊合作共同完成項目
? 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:
? Bachelor’s degree or higher in Engineering majority
? 本科以上工程背景
? 3+ years of relevant experience with a BS
? 本科以上3年工作經驗
? Experience of Active medical equipment
? 有源醫(yī)療設備/耗材經驗
? Team player willing to collaborate with peers
? 有團隊精神，容易合作
? Independent contributor who requires less or little supervision
? 有獨立工作能力，善于解決問題
? Previous medical device experience is a plus
? 有醫(yī)療行業(yè)經驗更好
? Good English Listening and Speaking
? 英語能基本聽說
? Desire to learn, explore and push team practices to modern standards
? Effective communicator and writer
推薦搜索關鍵字：Verification Engineer (驗證工程師)， Product Location (產品本地化)， NPI (新產品導入)
Your responsibilities include:
? Be responsible for Active medical equipment
? 負責有源醫(yī)療設備或有源耗材的相關工作
? Create medical device DHF and registration materials including the PTR
? 生成醫(yī)療設備的設計歷史文件與注冊資料，包括產品技術要求
? 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
? 設計驗證的測試方法，驗證測試方法以及確認測試工裝夾具
? Attend the design review meeting
? 參加設計評審會議
? Analyze the design change
? 分析設計變更
? Execute design verification
? 執(zhí)行設計驗證測試
? Create test plan, test protocol. Execute the test and generate test report
? 制定測試計劃，測試方案，執(zhí)行測試活動并生成測試報告
? Support design transfer including manufacture line set up
? 支持設計轉移包括產線搭建
? Support Labeling design
? 支持標簽設計
? Support packaging design
? 支持包裝設計
? Support deficiency letter and NMPA on-site audit
? 支持注冊發(fā)補單回復及NMPA現(xiàn)場審查
? Set up test environment.
? 搭建測試環(huán)境
? Coordinate and collaborate with global team members
? 與國外團隊合作共同完成項目
? 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:
? Bachelor’s degree or higher in Engineering majority
? 本科以上工程背景
? 3+ years of relevant experience with a BS
? 本科以上3年工作經驗
? Experience of Active medical equipment
? 有源醫(yī)療設備/耗材經驗
? Team player willing to collaborate with peers
? 有團隊精神，容易合作
? Independent contributor who requires less or little supervision
? 有獨立工作能力，善于解決問題
? Previous medical device experience is a plus
? 有醫(yī)療行業(yè)經驗更好
? Good English Listening and Speaking
? 英語能基本聽說
? Desire to learn, explore and push team practices to modern standards
? Effective communicator and writer
工作地點
上海市浦東新區(qū)飛渡路1258號
入職公司信息
- 入職公司: 北京外企人力資源服務云南有限公司
- 公司地址: 昆明五華區(qū)昌源中路新云港99號智立方17F
- 公司人數(shù): 1000-9999人
認證資質
人力資源服務許可認證
人力資源服務許可證是由國家人力資源與社會保障相關部門頒發(fā)，代表人才經紀人所在企業(yè)可以合法開展人力資源相關業(yè)務的資質證件。展示該標簽代表該企業(yè)發(fā)布此職位時已上傳《人力資源服務許可證》或《人力資源服務備案證書》并經由平臺審驗通過。
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外企德科北京外企德科人力資源服務上海有限公司（FESCO Adecco）：官方網站：http://www.fescoadecco.com/北京外企德科人力資源服務上海有限公司(外企德科 FESCO Adecco)是值得客戶信賴的人力資源解決方案提供商和全球合作伙伴，是中國人力資源服務行業(yè)最具競爭力和品牌價值的FESCO（北京外企服務集團）與全球人力資源服務行業(yè)領航者The Adecco Group（德科集團）于2010年成立的一家中外合資人力資源服務企業(yè)，為企業(yè)及個人提供業(yè)務外包、人事服務、招聘獵頭和員工福利等人力資源解決方案。目前，F(xiàn)ESCO Adecco在浙江、陜西、重慶、深圳、蘇州設立了分支機構，全國服務人數(shù)超過200萬名，服務客戶超20,000家。
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