Job title:
As a Senior Systems Engineer for NMPA in the Philips MR business, you will ensure that the submission process of the MR-products for the local market in China is optimal ensuring fast throughput time and alignment with global product development. You will do this by ensuring that the technical content of the submission package is aligned with the needs from NMPA. Alignment with the global MR R&D organization is key to achieve this.
Your role:
- Being part of the MR R&D team in Suzhou. This team of high-level technical engineers is responsible for design of components which are used for MR Systems developed worldwide as well as for the introduction and maintenance of the locally produced MR Systems for the Chinese market.
- Being located in Suzhou, Jiangsu in China. You are requested to frequently travel to the Philips office in Best, The Netherlands (current design owner of the MR Systems in scope) and potentially other Philips MR R&D locations in India and United States. This to ensure optimal alignment of the development process in the global MR R&D locations with the NMPA submission process.
- Reporting to the R&D HW Development / MR R&D Suzhou Site Leader in Suzhou with a dotted line to the System Engineering Group leader of MR R&D Best.
- Providing thorough understanding of NMPA standards and regulations for MR medical devices
- Supporting the NMPA certification process by translating details of the NMPA standards and regulations, as well as supplemental notices to the global R&D departments and (co-)generation of appropriate documentation.
- Guidance towards the global R&D team in translation of the MR NMPA standards and regulations into requirements, design and implementation
- Supporting life cycle management, complaint investigations and post market surveillance activities specifically related to NMPA standards and regulations for MR medical devices
- Driving improvements in NMPA Submission process to embed the NMPA Submission process in global New Product Development process in an efficient way to ensure that worldwide product introductions are done in the most efficient way
You're the right fit if:
- At least a Master's degree in physics, electronic engineering or mechanical engineering
- Good communication skills in Chinese and English
- Ability to collaborate in a global cross-functional team and experience in creating alignment between broad varieties of stakeholders (internal and external).
- Sensitive for cultural differences between China, Europe, US and India. Proven working experience in Europe and China.
- 5-year experience in high tech (system) engineering, like research, development or test and verification. Experience and knowledge with MRI systems is a pre.
- Experience in interpretation and implementation of medical standards in high tech systems in a global environment.
- Strong analytical skills, with high quality output.
- Very accurate and quality minded with a continuous drive to improve.
- Helicopter view with ability to good deep into the technical content.
- Proven skills in understanding complex products and it's documentation structure.
- Experience in NMPA standards and regulations as well as the differences with global standards. Hands-on experience with global submissions (e.g. EU-MDR, FDA and NMPA) is a pre.
- Understanding Risk Management processes and implementations in a medical environment.
- Experience in reporting to competent authorities on compliance with medical standards.
- Experience in defining and arranging tests in the context of the medical standard is a pre.
作为飞利浦磁共振(MR)业务部国家药品监督管理局(NMPA)高级系统工程师,你需确保磁共振产品在中国本土市场的注册申报流程达到最优水平,以实现快速审批周转,并与全球产品开发工作保持协同一致。达成此目标的核心在于,确保申报材料的技术内容符合 NMPA 的要求,而与全球磁共振研发(R&D)团队的协同则是实现这一目标的关键。
工作职责:
- 加入苏州磁共振研发团队。该团队由高水平技术工程师组成,不仅负责为全球范围内研发的磁共振系统设计相关组件,还需负责中国市场本土生产的磁共振系统的导入与维护工作。
- 工作地点位于中国江苏省苏州市。你需频繁前往荷兰的飞利浦办公室(当前相关磁共振系统的设计主导方所在地),并可能需前往飞利浦在印度及美国的其他磁共振研发地点。通过此类出差,确保全球磁共振研发地点的开发流程与 NMPA 申报流程实现最优协同。
- 直接向苏州研发硬件开发 / 磁共振研发苏州站点负责人汇报,同时虚线汇报给荷兰磁共振研发系统工程团队负责人。
- 深入理解磁共振医疗器械相关的 NMPA 标准与法规。
- 支持 NMPA 认证流程:向全球研发部门解读 NMPA 标准、法规及补充通知的细节,并协助编制或主导编制相关申报文件。
- 指导全球研发团队:将磁共振相关的 NMPA 标准与法规转化为具体的需求、设计方案及实施计划。
- 支持生命周期管理、投诉调查及上市后监测工作,重点关注与磁共振医疗器械 NMPA 标准和法规相关的内容。
- 推动 NMPA 申报流程的优化:将 NMPA 申报流程高效融入全球新产品开发流程,确保全球产品以最高效的方式完成上市导入。
任职要求:
- 拥有物理学、电子工程或机械工程专业硕士及以上学历。
- 具备良好的中英文沟通能力。
- 能够在全球跨职能团队中开展协作,并有能力协调各类内外部利益相关方,促成共识。
- 对中国、欧洲、美国及印度之间的文化差异具备敏感度,且拥有在欧洲和中国的实际工作经验。
- 拥有 5 年以上高科技(系统)工程领域工作经验,涵盖研究、开发或测试验证等方向;具备磁共振(MRI)系统相关经验者优先。
- 具备在全球环境下解读并实施医疗器械标准的经验,且有将其应用于高科技系统的实践经历。
- 具备出色的分析能力,能产出高质量工作成果。
- 工作严谨细致,注重质量,并有持续改进的动力。
- 具备全局视野,同时能够深入钻研技术细节。
- 经实践证明,具备理解复杂产品及其文档结构的能力。
- 熟悉 NMPA 标准与法规,了解其与全球标准的差异;具备全球申报(如欧盟《医疗器械法规》EU-MDR、美国食品药品监督管理局 FDA 及 NMPA 申报)实操经验者优先。
- 理解医疗器械领域的风险管理流程及实施方法。
- 具备向主管部门提交医疗器械标准合规性报告的经验。
- 具备在医疗器械标准框架下定义并安排相关测试的经验者优先。