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Your responsibilities include:
?Be responsible for Active medical equipment
?負責有源醫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
?支持注冊發補單回復及NMPA現場審查
?Set up test environment.
?搭建測試環境
?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:
?本科以上工程背景
?本科以上3年工作經驗
?有源醫療設備/耗材經驗
?有團隊精神，容易合作
?有獨立工作能力，善于解決問題
?有醫療行業經驗更好
?英語能基本聽說