R&D Engineer

推荐搜索关键字：Verification Engineer (验证工程师)， Product Location (产品本地化)， NPI (新产品导入)


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:

• 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年工作经验

• Experience of Active medical equipment

• 有源医疗设备/耗材经验

• Team player willing to collaborate with peers

• 有团队精神，容易合作

• Independent contributor who requires less or little supervision

• 有独立工作能力，善于解决问题

• Previous medical device experience is a plus

• 有医疗行业经验更好

• Good English Listening and Speaking

• 英语能基本听说

• Desire to learn, explore and push team practices to modern standards

• Effective communicator and writer