高级软件测试工程师-嵌入式系统（医疗设备）（混合办公）
Senior Software Test Engineer- Embedded Systems (Medical Devices) (Hybrid)
- 工作方式
- 混合办公
- 类型
- 全职
- 资历
- senior
- 部门
- 工程
- 编号
- R551577
职责
- 领导医疗设备嵌入式软件的软件验证和测试自动化工作。
- 设计和实施用于集成、系统、UI 和回归测试的自动化测试框架和测试脚本。
- 在整个产品生命周期内与软件、硬件、系统和质量团队密切合作。
- 与其他工程师合作开发和维护常见的测试基础设施，包括测试装置、模拟器和嵌入式系统仿真器。
- 确保测试用例的需求可追溯性符合监管标准（IEC 62304、ISO 14971）。
- 参与风险分析、根本原因调查和纠正预防措施。
- 审查软件文档，包括需求、设计和代码，以确保可测试性和完整性。
必备要求
- 计算机工程、计算机科学、电气工程、生物医学工程或相关专业的学士学位。
- 2年以上软件测试经验，重点关注嵌入式系统。
- 具有嵌入式软件系统开发和测试原理经验。
- 了解 IEC 62304、ISO 13485、ISO 14971、FDA QSR 等监管标准。
- 出色的沟通、领导和文档技能。
- 具有测试自动化经验。
优先条件
- 医疗器械行业或类似监管环境经验 2 年以上。
- 具有使用示波器、逻辑分析仪和 JTAG 等工具进行硬件/软件集成测试和调试的经验。
- 具有实时操作系统 (RTOS)、微控制器和通信协议（例如 CAN、I2C、SPI、UART）的经验。
- 熟悉嵌入式开发环境中的 CI/CD 管道。
- 拥有使用需求管理和测试工具（例如 Jama、DOORS）的经验。
- 具有 Python、Linux、Yocto、Qt/QML 和 Squish 经验。
- 软件测试认证（例如 ISTQB、ASQ）。
Responsibilities
- Lead software verification and test automation efforts for embedded software in medical devices.
- Design and implement automated test frameworks and test scripts for integration, system, UI, and regression testing.
- Collaborate closely with software, hardware, systems, and quality teams throughout the product lifecycle.
- Work with other engineers to develop and maintain common test infrastructure, including test fixtures, simulators, and embedded system emulators.
- Ensure requirements traceability of test cases in compliance with regulatory standards (IEC 62304, ISO 14971).
- Participate in risk analysis, root cause investigations, and corrective and preventive actions.
- Review software documentation, including requirements, design, and code, to ensure testability and completeness.
Must Have
- Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related field.
- 2+ years of experience in software testing with a focus on embedded systems.
- Experience with embedded software system development and testing principles.
- Knowledge of regulatory standards such as IEC 62304, ISO 13485, ISO 14971, and FDA QSR.
- Excellent communication, leadership, and documentation skills.
- Experience with test automation.
Preferred
- 2+ years of experience in the medical device industry or a similar regulated environment.
- Experience with hardware/software integration testing and debugging using tools such as oscilloscopes, logic analyzers, and JTAG.
- Experience with real-time operating systems (RTOS), microcontrollers, and communication protocols (e.g., CAN, I2C, SPI, UART).
- Familiarity with CI/CD pipelines in embedded development environments.
- Experience with requirements management and testing tools (e.g., Jama, DOORS).
- Experience with Python, Linux, Yocto, Qt/QML, and Squish.
- Software testing certifications (e.g., ISTQB, ASQ).
公司简介
史赛克（Stryker）致力于改善人们的生活，并对研发新型医疗器械产品充满热情。作为史赛克的工程师，您将运用尖端技术改善医疗保健，并为自己所做的工作感到自豪。在这里，您将与一群才华横溢、智慧超群的同事在充满支持的文化氛围中并肩工作，共同打造行业领先的医疗技术产品。我们重视员工的个人和职业发展，因此您也将拥有广阔的发展空间。