- 地点
- 阿拉米达,美国
- 类型
- 全职
- 发布
- 2026-04-20
- 资历
- senior
- 部门
- ADC 糖尿病护理
- 编号
- 31148168
职责
- 领导软件开发、验证和确认;负责按时交付符合预算目标的高质量嵌入式软件产品。
- 使用当前编程语言(例如 C、C++、C#、Python)设计和实现软件,具有嵌入式 C 开发方面的实践经验。
- 确定参数、结构和关键测试组件。编写、更新或执行测试设计、用例和流程,并报告结果。
- 根据需求规范,制定、维护和更新详细的设计和接口规范。
- 参与并支持软件源代码、脚本和程序的实施、开发、改进和修改。
- 调试、排查并隔离软件问题,并针对已发现的问题提供战略解决方案、分析和建议,以促进未来的开发。
- 协助评估选定的设计方案,通过测试并完整记录结果。
- 处理复杂问题,其中对情况或数据的分析需要评估可识别的因素。
- 在既定的程序和惯例范围内运用判断力来确定适当的行动。
- 参与并支持需求的收集、分析和验证。
- 参与编写、更新、开发和维护危害/风险分析规范,并提供支持。
- 参与并支持故障根本原因分析。
- 在软件主管的指导下,参与软件开发、验证和确认工作。
- 按照 FDA 指南,遵循已批准的软件开发设计控制程序。
- 支持管理层确定的所有公司举措,并支持质量管理体系 (QMS)、环境管理体系 (EMS) 和其他监管要求。
- 精通软件实施。
- 与质量保证工程师互动,以确保软件产品稳定可靠且质量非常高。
- 积极参与产品开发团队,负责新产品和服务的开发。
- 能够灵活调整工作优先级,并在团队环境中协作,及时完成多个项目的共同目标。
- 解决重大和/或复杂的技术问题,通过突破性技术增强医疗健康能力。
必备要求
- 计算机科学、工程数学或相关领域的学士学位。
- 至少6-8年相关工作经验,或硕士学位及4年以上相关工作经验。
- 优秀的书面和口头沟通能力。
- 精通当前主流编程语言(例如 C、C++、C#、Python 等)。
- 精通当前开发工具(IDE、调试器、单元测试框架和源代码控制管理)。
- 具备软件测试经验。
- 具备软件开发生命周期流程方面的经验。
- 需要具备良好的软件工程原理知识。
- 在技术能力、创造力和独立思考方面表现出色。
- 需要具备结构化软件开发/或对象建模设计经验。
- 需要具备安全关键型产品嵌入式系统软件开发经验。
- 具备基于模型的设计(UML 或 SysML)经验。
- 需要具备扎实的调试技巧和在嵌入式环境下使用调试器的经验。
- 优秀的故障排除能力是必备条件。
- 需要具备微处理器架构方面的知识。
- 能够同时处理多项任务并合理安排优先级。
- 具备指导初级团队成员的能力。
优先条件
- 了解符合 ISO、IEEE 或其他 FDA 认可标准的软件生命周期开发流程所描述的高质量软件工程原则。
- 具备医疗器械研发设计控制和法规方面的知识。
- 具备使用 Wi-Fi、低功耗蓝牙、TCP/IP 进行通信设计和测试的丰富知识和经验者优先考虑。
Responsibilities
- Lead software development, verification, and validation; responsible for on-time delivery of high-quality embedded software products within budget targets.
- Design and implement software using current programming languages (e.g., C, C++, C#, Python), with hands-on experience in embedded C development.
- Determine parameters, structures, and key test components. Write, update, or execute test designs, cases, and procedures, and report results.
- Develop, maintain, and update detailed design and interface specifications based on requirements specifications.
- Participate in and support the implementation, development, improvement, and modification of software source code, scripts, and programs.
- Debug, troubleshoot, and isolate software issues, and provide strategic solutions, analysis, and recommendations for identified issues to facilitate future development.
- Assist in evaluating selected design solutions, verify through testing, and fully document results.
- Handle complex problems where analysis of situations or data requires evaluation of identifiable factors.
- Exercise judgment within defined procedures and practices to determine appropriate action.
- Participate in and support requirements gathering, analysis, and verification.
- Participate in writing, updating, developing, and maintaining hazard/risk analysis specifications and provide support.
- Participate in and support fault root cause analysis.
- Under the guidance of a software supervisor, participate in software development, verification, and validation.
- Follow approved software development design control procedures in accordance with FDA guidelines.
- Support all corporate initiatives as determined by management and support the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements.
- Proficient in software implementation.
- Interact with quality assurance engineers to ensure software products are stable, reliable, and of very high quality.
- Actively participate in product development teams, responsible for the development of new products and services.
- Ability to flexibly adjust work priorities and collaborate in a team environment to timely accomplish shared goals of multiple projects.
- Solve significant and/or complex technical problems, enhancing healthcare capabilities through breakthrough technologies.
Must Have
- Bachelor's degree in Computer Science, Engineering Mathematics, or a related field.
- At least 6-8 years of relevant work experience, or a Master's degree with 4+ years of relevant work experience.
- Excellent written and verbal communication skills.
- Proficiency in current mainstream programming languages (e.g., C, C++, C#, Python, etc.).
- Proficiency in current development tools (IDE, debugger, unit testing frameworks, and source code control management).
- Experience in software testing.
- Experience in software development lifecycle processes.
- Good knowledge of software engineering principles is required.
- Demonstrated excellence in technical ability, creativity, and independent thinking.
- Experience in structured software development and/or object modeling design is required.
- Experience in embedded systems software development for safety-critical products is required.
- Experience with model-based design (UML or SysML).
- Solid debugging skills and experience using debuggers in embedded environments are required.
- Excellent troubleshooting skills are a must.
- Knowledge of microprocessor architecture is required.
- Ability to multitask and prioritize appropriately.
- Ability to mentor junior team members.
Preferred
- Knowledge of high-quality software engineering principles as described in software lifecycle development processes compliant with ISO, IEEE, or other FDA-recognized standards.
- Knowledge of medical device R&D design controls and regulations.
- Rich knowledge and experience in communication design and testing using Wi-Fi, Bluetooth Low Energy, TCP/IP is preferred.
公司简介
雅培是一家全球领先的医疗保健公司,致力于帮助人们在人生的各个阶段活得更加精彩。我们拥有改变生活的创新技术组合,涵盖医疗保健的各个领域,在诊断、医疗器械、营养品和品牌仿制药方面均拥有领先的业务和产品。我们拥有115,000名员工,服务于160多个国家和地区的人们。