- 地点
- 尔湾，美国
- 工作方式
- 混合办公
- 资历
- senior
- 部门
- 泌尿科部门（Axonics）
- 编号
- 613539
职责
- 参与有源植入式医疗器械固件的技术评估、规范制定和系统集成
- 支持固件架构和嵌入式开发，确保符合 IEC 62304 和 FDA 法规
- 识别和缓解技术潜在风险、网络安全漏洞和集成挑战
- 确保符合 FDA 上市前网络安全指南和 IEC 62443 标准
- 与跨职能团队合作，包括硬件、系统、风险管理、监管和临床利益相关者
- 为制造和开发提供完整的文档、可追溯性和 SDLC 工件
- 参与整个开发生命周期的软件和系统风险管理活动
- 开发和执行单元和集成测试，以及设计验证协议
- 有助于低功耗嵌入式设计、无线通信（BLE、NFC、RF）和实时操作系统集成
- 建立符合波士顿科学公司质量管理体系的固件开发生命周期流程
- 使用单元测试框架和硬件在环工具进行固件测试、调试和验证
- 支持涉及固件变更的监管提交（510(k)、PMA、CE Mark）
- 协助将产品设计从研发转移到制造
- 促进创新并促进研发工程团队内部的知识共享
必备要求
- 计算机科学、计算机工程、电子工程或相关领域的学士或以上学位
- 4 年以上嵌入式固件开发经验
- 拥有 2 年以上植入式、可穿戴或物联网医疗设备经验
- 精通基于微控制器的 C/C++
- 对低功耗嵌入式系统和 RTOS 开发有深入的了解
- 具有固件风险评估、网络安全和法规遵从性的经验
- 熟练使用示波器、逻辑分析仪及相关测试设备
- 拥有将 BLE 固件与移动（iOS/Android）和桌面（Windows）应用程序集成的经验
- 熟悉 Microsoft Visual Studio 和 C#/.Net
- 表现出沟通、文档和组织能力
优先条件
- 了解 ISO 13485、ISO 14971 和 FDA QSR 要求
- 具有医疗器械领域并岗尽职调查经验
- 具有安全引导加载程序、加密和 OTA 固件更新的实践经验
- 先进的 BLE 专业知识，包括配对、安全、GATT 配置文件定制和服务
- 具有 BLE 堆栈（例如 Nordic、Cri Sem）和低功耗性能优化经验
Responsibilities
- Participate in technical assessment, specification development, and system integration of firmware for active implantable medical devices
- Support firmware architecture and embedded development, ensuring compliance with IEC 62304 and FDA regulations
- Identify and mitigate technical risks, cybersecurity vulnerabilities, and integration challenges
- Ensure compliance with FDA premarket cybersecurity guidance and IEC 62443 standards
- Collaborate with cross-functional teams, including hardware, systems, risk management, regulatory, and clinical stakeholders
- Provide complete documentation, traceability, and SDLC artifacts for manufacturing and development
- Participate in software and system risk management activities throughout the development lifecycle
- Develop and execute unit and integration tests, as well as design verification protocols
- Contribute to low-power embedded design, wireless communication (BLE, NFC, RF), and RTOS integration
- Establish firmware development lifecycle processes compliant with Boston Scientific's quality management system
- Perform firmware testing, debugging, and verification using unit test frameworks and hardware-in-the-loop tools
- Support regulatory submissions involving firmware changes (510(k), PMA, CE Mark)
- Assist in transferring product design from R&D to manufacturing
- Foster innovation and knowledge sharing within the R&D engineering team
Must Have
- Bachelor's degree or higher in Computer Science, Computer Engineering, Electrical Engineering, or a related field
- 4+ years of experience in embedded firmware development
- 2+ years of experience with implantable, wearable, or IoT medical devices
- Proficiency in C/C++ for microcontrollers
- Deep understanding of low-power embedded systems and RTOS development
- Experience with firmware risk assessment, cybersecurity, and regulatory compliance
- Proficiency with oscilloscopes, logic analyzers, and related test equipment
- Experience integrating BLE firmware with mobile (iOS/Android) and desktop (Windows) applications
- Familiarity with Microsoft Visual Studio and C#/.NET
- Demonstrated communication, documentation, and organizational skills
Preferred
- Knowledge of ISO 13485, ISO 14971, and FDA QSR requirements
- Experience with due diligence in the medical device field
- Hands-on experience with secure bootloaders, encryption, and OTA firmware updates
- Advanced BLE expertise, including pairing, security, GATT profile customization, and services
- Experience with BLE stacks (e.g., Nordic, Cri Sem) and low-power performance optimization
公司简介
作为医学科学领域40余年的领导者，波士顿科学始终致力于解决人类生命中最重要的挑战，并以“推动生命科学发展”为使命，通过创新的医疗解决方案改变生活，改善患者生活，为客户创造价值，并支持员工及所在社区。如今，作为一家全球性企业和全球企业公民，公司比以往任何时候都更有责任将这些价值观践行到所做的每一件事中。因此，选择在波士顿科学公司 (NYSE: BSX) 工作不仅仅是为了事业，更是个人的追求。公司深知营造多元化和包容性的工作环境有助于提升创新能力，这对于推进生命科学和改善患者健康至关重要，因此倡导包容、平等，并为所有人提供机会。波士顿科学公司是一家机会均等的雇主，在招聘、录用、岗位分配、晋升、薪酬及所有其他人事决策中，不考虑种族、宗教、肤色、国籍、公民身份、性别、性取向、性别认同、性别表达、退伍军人身份、年龄、精神或身体残疾、遗传信息或任何其他受保护的类别。