1. Conduct hardware/software module testing, system integration testing, and defect tracking with regression testing 开展硬件模块、软件系统及整机集成测试,跟踪缺陷闭环并实施回归测试。
2. Coordinate with external labs for system performance testing and type testing to ensure compliance with domestic/international standards. 协调外部实验室执行整机性能测试与型式检验,确保符合国内外标准要求。
3. Develop test protocols/plans and design traceable test cases to address hardware, software, and system requirements, ensuring compliance with quality systems and regulatory standards. 制定测试方案与计划,设计覆盖硬件、软件及系统需求且可追溯的测试用例,确保符合质量体系及法规要求。
4. Monitor latest regulations/standards, drive compliance improvements for under-development and mass-produced product testing (hardware/software/system). 协助跟踪最新法规标准,推动在研及量产产品的硬件 / 软件 / 系统测试合规性改进。
5. Manage end-to-end product lifecycle testing, conduct system verification/validation, generate test reports, and ensure defect closure. 统筹产品全生命周期测试,开展系统验证 / 确认,输出测试报告并推动缺陷闭环。
6. Prepare and review test-related documentation for medical device registration, ensuring test data and reports comply with regulatory requirements. 编制并审核医疗器械注册资料中的测试相关部分,确保测试数据及报告的合规性。
7. Support R&D lab operations, including test equipment and environment maintenance. 协助研发实验室运维,维护测试设备及环境。。
任职要求:
1. Bachelor's degree or higher in Biomedical Engineering, electronics and information, Automation control, or related fields with 3+ years of R&D or testing experience for bachelor's holders. 生物医学工程、电子信息工程、自动化控制等相关专业本科及以上学历,本科需具备3年以上开发或测试经验。
2. Proficient in hardware-software communication testing (RS-485/RS-232/CAN/Ethernet protocols) with hands-on system integration testing and debugging experience. 熟练掌握软硬件通信测试(RS485/RS232/CAN/以太网等协议),具备系统联动测试与调试实战经验。
3. Familiar with medical device testing processes and quality management workflows. 熟悉医疗器械测试流程及质量管理体系运作。
4. Proficient in medical device standards including IEC 60601 series and ISO 13485, with expertise in EMC testing and safety compliance requirements. 熟悉IEC 60601系列、ISO 13485等医疗器械标准,掌握EMC测试以及安规测试要求。
5. Familiar with environmental tests, fault initiation tests, packaging, life endurance, accelerated aging tests, and other test methods. 熟悉环境试验、故障激发试验、包装、寿命耐久及加速老化测试等试验方法。
6. Excellent written English skills for test reports coupled with basic verbal communication abilities. 具备优秀的英文测试报告撰写能力及基础英文口语沟通技能。
7. Experience in medical imaging systems or large-scale medical equipment testing preferred; master's degree holders prioritized. 具有医疗影像系统或大型医疗设备测试经验者优先,硕士学历优先。