高级软件工程师

该职位来源于猎聘 职责描述: Job purpose 职位目标 The Sr. Software Engineer position is a key member of R&D Engineering Group for Bracco Imaging Medical Technologies (BIMT) for Medical Devices used in Cardiovascular, Imaging and Radiology suites.

The individual will be involved in all phases of the Software Development Lifecycle (SDLC), including concept development, requirements, design, implementation, testing and documentation for medical devices product development. This role leverages software development proficiency to translate product requirements into code and document work to ensure compliance within a highly regulated Product Development Process (PDP) and Quality Management System (QMS).

This individual will be instrumental in designing, planning and coordinating work teams, as well as providing technical support. He/She will also generate innovative solutions, trying different and novel ways to deal with problems and opportunities. 高级软件工程师职位是博莱科成像医疗技术（BIMT）研发工程组的关键成员，负责心血管、成像和放射医学套件中使用的医疗设备。候选人将参与软件开发生命周期（SDLC）的所有阶段，包括医疗器械产品开发的概念开发、需求、设计、实施、测试和文档。该岗位利用软件开发熟练程度将产品需求转化为代码和文档工作，以确保在高度规范的产品开发过程（PDP）和质量管理系统（QMS）内的遵从性。 该岗位在设计、规划和协调团队工作以及提供技术支持方面发挥作用，并能够产生创新解决方案，尝试不同和新颖的方法来处理问题和寻找机会。 Main Responsibilities, Activities, Duties and Tasks

主要工作职责，活动和任务

• Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position. 关注和遵守公司要求的质量、环境健康手册、管理体系和管理政策、目标和该职位的相关的法规要求。
• Collaborate with project leaders and other R&D and engineering groups to develop medical devices.

与项目负责人和其他研发和工程团队合作开发医疗设备。

• Support the software technology transfer from global R&D teams, have an in-depth understanding of the working principle of the product, the details and requirements of the software development process, and be proficient in the original software code, etc. 支持从国外研发团队的软件技术转移，深入了解产品工作原理，软件开发过程的细节和要求，熟练掌握软件原代码等。
• Take responsibility for the entire software development lifecycle for software subsystems and components, including software design and development plan, software requirement definition, software design, software construction, code reviews, software verification and test, software final release and software maintenance according to medical device development processes. 根据医疗器械开发流程，负责软件子系统和组件的软件开发生命周期，包括软件策划、软件需求定义、软件设计、软件构建、软件调试、代码审查、软件验证及测试、最终发布和软件维护等各项活动。
• Understand the product’s intended use and clinical procedures, interpret customer needs and understand design inputs, and follow clinical workflows and implement into product software.

了解产品的预期用途和临床操作，解读用户需求，了解设计输入，并根据临床工作流程，实施到产品的软件设计中。

• Coordinate internal and external software development resources, evaluate, define and break down work tasks, build software development plan, track the software development progress, and review and accept deliverables. 协调内外部软件开发资源，评估、定义和分解工作任务，制定软件开发计划，跟踪软件开发过程，评审和验收交付成果。
• Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements. 了解符合法规要求的基本行业标准、设计要求和测试策略。
• Support problem solving, identify potential solutions, and evaluate them against requirements.

支持问题解决，确定潜在的解决方案并根据需求对其进行评估。

• With supervision, create or refine design documentation, such as the Design History file per company design control procedures; Review the necessary documents with project teams.

创建或完善设计文档，例如按照公司的设计控制程序要求的DHF文件，与项目团队一起审阅必要的文档。

• Support the improvement of the company's software design and development process to comply with design control and risk management under the quality management system. 支持完善公司软件设计开发流程，以符合量管理体系下的设计控制和风险管理。
• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success and contribute to the project as a team member. 与研发、质量、生产、法规、临床、市场和项目管理协同工作，确保项目成功。
• Cooperate with manufacture team to define product and software test method, support technical analysis and fixing issues found in manufacture testing. 与制造团队合作制定产品和软件测试方法，支持分析和解决制造测试中发现的问题。
• Support regulation approval of local and imported products, including but not limited to support type testing, prepare software related dossiers, answer technical questions etc. 支持本地和进口产品的注册审批，包括但不限于支持型式试验，准备相关软件技术文档，回答技术问题等。
• Other work assigned by superior. 上级主管安排的其他工作。 任职要求: Education 教育背景
• B.S. or M.S. in Computer Science, Software Engineering, Electrical Engineering, Mathematics, or related fields

计算机科学、软件工程、电气工程、数学或相关专业的学士学位或硕士学位 Professional Experience, Knowledge & Technical Skills 工作经验，知识和硬性技能

• 8+ years of relevant experience in embedded software development or 5+ years of software development in medical devices.

8年以上嵌入式软件开发经验或5年以上医疗器械软件开发经验。

• Understanding of computer architecture principles and embedded systems design with preemptive multitasking, real-time operating systems. 了解计算机架构原理和嵌入式系统设计，具有抢先多任务处理、实时操作系统等知识。
• Deep proficient in embedded software, C/C++ and QT application development, familiar with embedded Linux driver and application development, Bootloader, real-time operating system. 精通嵌入式软件，C/C++及QT等应用程序开发，熟悉嵌入式Linux驱动及应用开发，Bootloader，实时操作系统。
• Familiar with ARM microcomputer development and STM32. 熟悉ARM单片机开发，熟悉STM32。
• Familiar with SDLC (Software Development Life Cycle) processes, understand the applied regulatory and compliance standards. Application Lifecycle Management /Traceability tools. 精通软件开发生命周期流程，了解适用的法规和合规标准。能应用生命周期管理/可跟踪工具。
• Familiar with hardware design and debugging, proficient in hardware debugging tools and methods. Experience with communications protocols, like USB, Ethernet, RS232, UART, TCP/IP, etc. 熟悉硬件设计及调试，熟练掌握硬件调试工具及方法，熟悉常见的通信协议，如USB，以太网，RS232, UART, TCP/IP等。
• Experience with tools for static/dynamic analysis, memory management, code coverage and techniques for analyzing software. 具有静态/动态分析工具、内存管理、代码覆盖和软件分析技术的经验。
• Familiar with the medical device quality management system (including the software quality control). 熟悉医疗器械质量管理体系（包括软件的质量控制）
• Self-motivated, proactive, ability to independently analyze and solve problems.

具有自我激励、积极主动，独立分析和解决问题的能力；

• Comfortable working in a cross-culture environment, strong written, verbal and, communication and presentation skills in both English and Chinese. 适应在跨文化环境中工作，良好的中英文书面、口头沟通能力。 Preferred 优先
• Software development experience in high-pressure syringes or infusion devices (such as motor control, fluid control, etc.) 有高压注射器或输注类器械的软件开发经验（包含电机控制、流体控制等）
• Experience in medical device software NMPA registration application and Quality system audit. 有医疗器械软件注册申报和体系审核经验