- 地点
- 伦敦，加拿大
- 发布
- 2025-12-02
- 编号
- 116
职责
- 为系统级医疗产品（硬件/软件）设计、实施、维护并记录固件，涵盖新产品开发项目从概念到发布再到生产的全过程。
- 与硬件工程师合作定义系统需求；与高级固件工程师合作制定固件设计计划。
- 担任设计负责人工程师（DRE），为医疗器械和测试设备中的嵌入式系统设计和开发固件。
- 测试和调试固件；优化固件代码以提高效率和可靠性。
- 记录固件设计，供未来参考和调试；提供产品更新及相关文档的后期支持。
- 定义、记录和控制项目中的系统需求；开发系统级硬件/软件架构。
- 制定项目的软件和系统风险及危害分析活动；管理软件验证和确认活动。
- 与项目负责人协调，用固件项目计划参与主项目计划。
- 作为项目核心团队的一部分，在多个项目中交付固件编程。
- 遵循新产品开发流程和知识文档流程，收集项目知识并规划工作。
- 主导制造转移活动，将固件知识转移到运营团队。
- 遵守相关的健康与安全法规，包括《工作场所安全与保险法》、《职业健康与安全法》等。
必备要求
- 工程学位（计算机科学、软件、系统、电气、生物医学或机电一体化）。
- 5年固件工程经验，从设备概念到注册及商业化的成熟业绩。
- 2年医疗器械行业经验，涉及固件开发的实践经验，包括需求定义、用例工作流程、功能架构和系统设计。
- 在职能医疗器械开发项目团队中担任领导角色的丰富经验。
- 良好的口头和书面沟通能力，包括报告写作能力。
- 良好的人际交往能力；独立工作能力。
- 具备以下计算机素养能力：
- 拥有 MS Word、MS Excel 和 MS Project 的经验。
- 嵌入式系统设计与编程（C 和/或 C++）。
- 使用过 Python、Java 等脚本语言的经验。
- 跨平台框架（例如跨平台或以上 Windows、Linux、MacOS 等）。
- 呼吸相关医疗领域的基础知识。
- 了解适用于新产品开发的监管要求，例如 ISO 设计控制、FDA GMP 和 HBP 要求。
- 了解新产品开发中适用的监管要求，如 ISO-9001 设计控制（IEC62304）、FDA、GMP 及治疗产品管理局（TPD）要求。
- 创造性问题解决能力。
Responsibilities
- Design, implement, maintain, and document firmware for system-level medical products (hardware/software), covering new product development projects from concept through release to production.
- Collaborate with hardware engineers to define system requirements; work with senior firmware engineers to develop firmware design plans.
- Serve as Design Responsible Engineer (DRE) to design and develop firmware for embedded systems in medical devices and test equipment.
- Test and debug firmware; optimize firmware code for efficiency and reliability.
- Document firmware design for future reference and debugging; provide post-release support for product updates and related documentation.
- Define, document, and control system requirements for projects; develop system-level hardware/software architecture.
- Develop software and system risk and hazard analysis activities for projects; manage software verification and validation activities.
- Coordinate with project leads and contribute firmware project plans to master project plans.
- Deliver firmware programming across multiple projects as part of the core project team.
- Follow new product development and knowledge documentation processes to capture project knowledge and plan work.
- Lead manufacturing transfer activities to transfer firmware knowledge to operations teams.
- Comply with relevant health and safety regulations, including the Workplace Safety and Insurance Act, Occupational Health and Safety Act, etc.
Must Have
- Engineering degree (Computer Science, Software, Systems, Electrical, Biomedical, or Mechatronics).
- 5 years of firmware engineering experience with a proven track record from device concept to registration and commercialization.
- 2 years of medical device industry experience with hands-on firmware development, including requirements definition, use case workflows, functional architecture, and system design.
- Extensive experience in a leadership role within functional medical device development project teams.
- Strong verbal and written communication skills, including report writing.
- Strong interpersonal skills; ability to work independently.
- Computer literacy in:
- Experience with MS Word, MS Excel, and MS Project.
- Embedded systems design and programming (C and/or C++).
- Experience with scripting languages such as Python, Java.
- Cross-platform frameworks (e.g., cross-platform or above Windows, Linux, MacOS, etc.).
- Basic knowledge of respiratory medical field.
- Knowledge of regulatory requirements applicable to new product development, such as ISO design controls, FDA GMP, and HBP requirements.
- Knowledge of regulatory requirements applicable to new product development, such as ISO-9001 design controls (IEC62304), FDA, GMP, and Therapeutic Products Directorate (TPD) requirements.
- Creative problem-solving skills.
公司简介
Trudell 国际医疗（TMI）致力于寻找创新和创造性的解决方案，开发持续改变全球人们生活的医疗器械。TMI 位于加拿大安大略省伦敦市的一座现代化设施内，提供舒适的工作环境和尊重且以家庭为导向的文化。作为 Trudell Medical International 的员工，您不仅能参与医疗器械技术前沿产品的开发，还有机会与一流的专业团队一起完成具有挑战性的工作。