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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 de

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 deliver

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。

Company introduction

Bracco is a world-renowned medical group. Founded in Italy in 1927, Bracco has been operating in more than 100 markets worldwide, with more than 3,960 employees and annual revenue of more than 2 billion euros, about 88% of which comes from overseas markets outside Italy. The group invests nearly 9% of its annual net sales in research and development (imaging diagnosis and medical devices) and owns more than 2,200 patents. Bracco group is headquartered in Milan, Italy. Bracco group is consisted of three entites - the Bracco imaging diagnosis company (diagnostic imaging), Bracco medical system (medical devices and high-end contrast agent injection system), and the Italian diagnostic center specializing in clinical diagnosis. Bracco imaging diagnostics is an original research and development company whose success has witnessed the history of the entire imaging industry. The company's unique products, covering radiation, CT, nuclear magnetic resonance, ultrasound and nuclear medicine and other fields. In 2001, Bracco group acquired ACIST, which provides high-quality medical devices and high-end contrast injection systems for the field of radiation and radiotherapy. ACIST is headquartered in Minneapolis and has offices in Europe and Asia. The advanced equipment of ACIST has been adopted by well-known medical centers in more than 40 countries, benefiting tens of millions of patients worldwide in cardiovascular angiography. In addition, the group has opened an advanced polyclinic in Milan, the Italian diagnostic center (CDI), which provides services directly to patients for more than 30 years. The ambulatory center offers a full range of preventive, diagnostic, rehabilitation and personalized services, with a particular focus on radiosurgery and same-day surgery.