Your responsibilities include:
•Be responsible for Active medical equipment
•负责有源医疗设备或有源耗材的相关工作
•Create medical device DHF and registration materials including the PTR
•生成医疗设备的设计历史文件与注册资料，包括产品技术要求
•Support type testing including GB9706.1 safety and YY0505 EMC and GB/T 14710 Environmental test
•支持型检，包括GB9706.1安全测试， YY0505 EMC测试与 GB/T 14710环境测试
•Create BOM/Finished Good documents
•生成BOM/Finished Good documents
•Design the verification test method, do test method validation and test fixture qualification
•设计验证的测试方法，验证测试方法以及确认测试工装夹具
•Attend the design review meeting
•参加设计评审会议
•Analyze the design change
•分析设计变更
•Execute design verification
•执行设计验证测试
•Create test plan, test protocol. Execute the test and generate test report
•制定测试计划，测试方案，执行测试活动并生成测试报告
•Support design transfer including manufacture line set up
•支持设计转移包括产线搭建
•Support Labeling design
•支持标签设计
•Support packaging design
•支持包装设计
•Support deficiency letter and NMPA on-site audit
•支持注册发补单回复及NMPA现场审查
•Set up test environment.
•搭建测试环境
•Coordinate and collaborate with global team members
•与国外团队合作共同完成项目
•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年工作经验
•有源医疗设备/耗材经验
•有团队精神，容易合作
•有独立工作能力，善于解决问题
•有医疗行业经验更好
•英语能基本听说