- 地点
- 阿登山，美国
- 工作方式
- 混合办公
- 类型
- 全职
- 部门
- 泌尿外科
- 编号
- 628105
职责
- 参与有源植入式医疗设备的技术评估、技术规范制定和固件架构及嵌入式软件的验证。
- 支持符合 IEC 62304 和适用 FDA 法规的固件架构、详细设计和实时嵌入式开发。
- 确保符合 ISO 13485、ISO 14971、FDA 质量体系法规和医疗器械网络安全标准，包括 FDA 上市前网络安全指南和 IEC 62443。
- 识别并缓解与固件相关的风险、网络安全漏洞和系统集成挑战，包括与收购技术相关的风险和挑战。
- 与硬件、系统、风险管理、监管事务和临床团队合作，确保设备无缝集成和设计执行。
- 开发和维护全面的设计文档、可追溯性矩阵和软件开发生命周期工作，以支持 510(k)、PMA 和 CE 标志提交。
- 在产品开发生命周期中，参与软件和系统风险管理活动。
- 制定并执行单元测试和集成测试策略，并支持设计验证活动。
- 在低功耗嵌入式设计、无线通信技术（包括 BLE、NFC 和 RF 遥测）以及实时操作系统集成方面提供技术领导。
- 使用示波器、逻辑分析仪、硬件在环仿真和自动化测试环境执行固件测试、调试和验证。
- 建立并改进与波士顿科学公司质量管理体系相一致的固件开发生命周期流程。
- 支持产品从研发到生产制造和持续工程的转移。
- 促进研发工程团队内部的创新、持续改进和知识共享。
必备要求
- 计算机科学、计算机工程、软件工程、电气工程或相关领域的学士学位。
- 至少2年嵌入式固件开发经验。
- 至少1年在受监管环境下工作的经验（医疗器械行业优先）。
- 精通 C/C++，能够进行基于微控制器的固件开发。
- 具备开发低功耗嵌入式系统（无论是否包含实时操作系统）的经验。
- 具备固件风险评估、网络安全原则和合规软件开发方面的实践经验。
- 具备使用 Microsoft Visual Studio 进行基于 PC 的应用程序开发知识。
- 较强的沟通、文档撰写和组织能力。
优先条件
- 熟悉 ISO 13485、ISO 14971 和 FDA 质量体系法规要求。
- 在医疗器械行业拥有支持并购尽职调查活动的经验。
- 具备安全引导加载程序、加密协议和无线固件更新的实际操作经验。
- 在蓝牙低功耗领域拥有丰富的专业知识，包括外围设备、中心设备和双重角色、配对、GATT 配置文件、安全实施和定制服务。
- 具有使用 Nordic 或 Onsemi 等 BLE 软件协议栈的经验，并针对超低功耗和性能受限环境进行优化。
Responsibilities
- Participate in technical evaluation, specification development, and verification of firmware architecture and embedded software for active implantable medical devices.
- Support firmware architecture, detailed design, and real-time embedded development compliant with IEC 62304 and applicable FDA regulations.
- Ensure compliance with ISO 13485, ISO 14971, FDA Quality System Regulations, and medical device cybersecurity standards, including FDA premarket cybersecurity guidance and IEC 62443.
- Identify and mitigate firmware-related risks, cybersecurity vulnerabilities, and system integration challenges, including those related to acquired technologies.
- Collaborate with hardware, systems, risk management, regulatory affairs, and clinical teams to ensure seamless device integration and design execution.
- Develop and maintain comprehensive design documentation, traceability matrices, and software development lifecycle work to support 510(k), PMA, and CE marking submissions.
- Participate in software and system risk management activities throughout the product development lifecycle.
- Develop and execute unit and integration test strategies, and support design verification activities.
- Provide technical leadership in low-power embedded design, wireless communication technologies (including BLE, NFC, and RF telemetry), and real-time operating system integration.
- Perform firmware testing, debugging, and verification using oscilloscopes, logic analyzers, hardware-in-the-loop simulation, and automated test environments.
- Establish and improve firmware development lifecycle processes aligned with Boston Scientific's quality management system.
- Support product transfer from R&D to manufacturing and sustaining engineering.
- Foster innovation, continuous improvement, and knowledge sharing within the R&D engineering team.
Must Have
- Bachelor's degree in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related field.
- At least 2 years of experience in embedded firmware development.
- At least 1 year of experience working in a regulated environment (medical device industry preferred).
- Proficiency in C/C++ for microcontroller-based firmware development.
- Experience developing low-power embedded systems (with or without RTOS).
- Hands-on experience with firmware risk assessment, cybersecurity principles, and compliant software development.
- Knowledge of PC-based application development using Microsoft Visual Studio.
- Strong communication, documentation, and organizational skills.
Preferred
- Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations.
- Experience supporting M&A due diligence activities in the medical device industry.
- Hands-on experience with secure bootloaders, cryptographic protocols, and wireless firmware updates.
- Deep expertise in Bluetooth Low Energy, including peripheral, central, and dual roles, pairing, GATT profiles, security implementation, and custom services.
- Experience with BLE software stacks such as Nordic or Onsemi, optimized for ultra-low power and performance-constrained environments.
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。