高级系统工程师

到岗时间：不限 婚况要求：不限 Job purpose 职位目标 The Senior systems engineer will play a key role in the New Product Development (NPD) team at Bracco Image Medical Technologies (BIMT), applying the principles of systems engineering to solve complex, interdisciplinary challenges. This position is responsible for developing system-level solutions that meet customer needs and regulatory requirements. You will collaborate with cross-functional teams to define requirements, develop system architectures, lead technical development, and perform verification and validation activities. This role spans the entire product development life cycle - from early concepts through market release - and focuses Ｏn the overall system engineering deliverables and activities of next-generation contrast agent injection systems and related consumables for medical devices. 高级系统工程师负责在新产品开发（NPD）团队中发挥关键作用，运用系统工程的原理解决复杂的跨学科挑战。该职位负责开发满足客户需求和法规要求的系统级解决方案。您将与跨职能团队合作，定义需求，开发系统架构，主导技术开发，并执行验证和确认活动。这个角色跨越了整个产品开发生命周期——从早期概念到市场发布——并专注于下一代造影剂注射系统及配套耗材等医疗器械的总体系统工程交付成果和活动。 Main Responsibilities, Activities, Duties and Tasks 主要工作职责，活动和任务 1. Lead the integrated solutions of medical device product, responsible for realization of full life cycle management of medical device products to ensure quality and compliance. 主导针对医疗器械产品的整体解决方案，实现完整的医疗器械产品生命周期管理，以确保质量和合规性。 2. Collaborate with internal and external stakeholders to collect and define specific requirements, including user needs collection and analysis, compliance of product-related regulations and standards, and transform them into system and subsystem requirements as inputs to product core team. 与内部和外部利益相关者合作，收集和定义具体需求，包括用户需求收集和分析，产品相关法规和标准的符合性，并将其转化为系统和子系统的需求，并将其输入到产品核心团队。 3. Lead the development and documentation of the product systems architecture and systems level design, trade-off of product/system design specifications and interfaces, review and determine feasibility of potential solutions and technical reviews. 主导产品系统架构和系统级设计的开发和文档化，权衡产品/系统设计规范和接口，审核和确定潜在解决方案的可行性。 4. Lead and execute systems engineering activities across all phases of development, including but not limit to feasibility study, high level product design, technical and design reviews etc. 领导并执行所有开发阶段的系统工程活动，包括但不限于可行性研究、产品概要设计、技术评审和设计评审等。 5. Lead the full risk management activities for the products, documenting risks and ensuring risk control requirements are met. 主导全面的产品风险管理活动，记录风险并确保满足风险控制的要求。 6. Lead and execute system level verification and validation (V&V) activities, including test plans, test protocols, and test reports for product integration testing, and maintain traceability of requirements through design and verification activities. 主导并执行系统级别的设计验证和确认活动，包括产品集成测试计划、测试方案和测试报告, 以及维护从需求到设计和验证活动的可追溯性。 7. Manage the creation and maintenance of DHF (Design History File) and DMR (Device Master Record) as well as associated technical evidence, and integration of deliverables from global design teams and external partners. 管理DHF（设计历史文件）和DMR（设备主记录）以及相关技术证据的创建和维护，以及整合来自国外设计团队和外部合作伙伴的可交付成果。 8. Support the writing of product registration documents, submission and audits, including but not limited to type tests, preparation of R&D-related documents, answering technical questions, and support CER and clinical evaluations, etc. 支持产品注册文档的撰写，注册递交和审核，包括但不限于支持/执行型式试验，准备研发相关文档，回答技术问题，支持CER和临床评价等。 9. Work closely with local and global R&D engineers (mechanical, electrical, software, etc.) and cross-functional departments (Purchasing, Manufacturing, Quality, Regulatory and Marketing, etc.) to ensure the product are designed and integrated according to project requirements. 与国内外研发工程师（机械、电子、软件等）和跨职能部门（采购，制造，质量，法规和营销等）紧密合作，确保产品按照项目要求设计和集成。 10. Apply analytical thinking to resolve complex system interaction challenges, the investigation and resolution of product related technical issues. 运用分析性思维解决复杂的系统交互挑战，调查和解决产品相关的技术问题。 11. Ensure compliance with BIMT’s Quality Management System (QMS) and documentation standards, makes a substantial contribution to the innovation of product and processes. 确保符合BIMT的质量管理体系（QMS）和文件标准，为产品和流程的创新持续做出贡献。 12. Other work assigned by superior. 上级主管安排的其他工作。