东莞招聘

职位描述：
Advanced Application Engineer
Based in Shenyang

The purposes of this position are:
岗位目的
1. To organize and complement clinical research related works within PCC Shenyang, therefore make sure all jobs finished effectively and exactly.
2. To supply clinical related suggestions and conclusion as input and guide related team or member’s jobs
3. To organize application specification and clinical research and development work, lead clinical innovation.

Reporting Line：
工作关系
      a) Direct Governance直接关系:
- Higher hierarchical reporting line直接汇报关系的上级职位: SV&V manager
- Lower hierarchical reporting line下属职位及人数: 0
      
       b) Indirect Governance 间接关系:
- Indirect Subordinate Reporting Line间接下属管理的职位及人数: 项目经理，0

c) Cooperative Department对外关系（需要同哪些外部机构进行联系及其目的）:
      1. Marketing: to introduce clinical design input and obtain the recognition.市场部门：介绍临床设计输入和认可
2. Clinical application: to support application training to senior clinical application specialists.临床应用：为高级临床应用专家提供应用培训支持
3. Clinical Science: to support clinical research on new application development.临床科学：为高级临床应用开发提供支持
4. Service Department: System install, maintain, update and upgrade for CAT.服务部门：用户接受性测试时，设备的安装，维护，更新，升级
5. Clinical Trial Institution: to get the approval and archive SFDA documents. 临床测试机构药理基地：SFDA测试文档的存档备份，审核批准
      6. Ethics Committee: to get the approval of SFDA clinical trial protocol.临床机构伦理委员会：SFDA测试计划的审核批准
      7. Clinical experts: to discuss SFDA clinical trial protocol; to analyze clinical design input; to perform forward looking research; to complete clinical validation.临床机构临床专家：讨论测试方案；分析临床设计输入；进行医疗设备的前瞻性研究；配合完成确认活动
      8. Statistic company: to conduct statistical work with SFDA clinical data; to generate statistical report. 临床学统计公司：完成SFDA临床统计活动及报告
      9. China Food and Drug Administration (CFDA): to follow up the latest development of laws and regulations; to ensure related documents get the approval accordingly. 国家食品药品监督局：及时更新国家法规的最新进展，保证临床测试材料能够顺利通过国家的审核
     10. Food and Drug Administration (FDA): to follow up the latest development of laws and regulations; to ensure related documents get the approval accordingly. 美国食品药品监督局：及时更新国家法规的最新进展，保证临床测试材料能够顺利通过国家的审核
      11. European Commission (CE): to follow up the latest development of laws and regulations; to ensure related documents get the approval accordingly.欧盟：及时更新国家法规的最新进展，保证临床测试材料能够顺利通过国家的审核


Key Areas of Responsibility：
主要工作职责

1. To organize clinical related technolgy and doctors’ requeirments researching, according to ARS (application requirement specification) process, edit and maintain, update ARS，ensure valued clinical input can be archived effectively.
根据ARS流程，组织调查行业发展趋势，医生临床使用需求等，组织完成相关项目的ARS（应用需求设计规格）编写，维护及更新。保证项目能够按时得到正确、有效的临床应用需求输入。从临床方面指导产品或功能的开发，保证产品或功能的临床可接受性。

2. To organize and man clinical research and development work on new application, algorithm or features.组织和开展临床应用，算法和功能的临床研究和开发工作

3. To organize and perform internal and external clinical evaluation, to validate the maneuverability of product and function under clinical circumstances.
组织、实施项目中内部临床评价和外部临床评价，保证按时输入有效的求。组织完成产品在临床环境下确认产品或功能的临床可操作性。。

4. To organize and perform internal and external CAT according to CAT process in PRP, to validate the clinical satisfaction and acceptability of product and function under clinical circumstances.
组织，实施产品或功能的用户可接受性测试，在临床的环境下确认产品的用户满意性和临床可接受性。。

5. Based on the requirement of project, organize, implement, monitor and complete SFDA clinical trial according to CFDA process and acquire related clinical data and documents.
依据临床测试流程中的CFDA部分，组织，实施，监察C’FDA临床测试活动，获得SFDA测试需要的所有临床资料。

6. To organize and compile report which in accordance to CE legislation according to CE process.
依据临床测试流程中的CE部分，组织编写符合CE要求的临床评估报告。为项目提供及时有效的临床评估报告。

7. To provide clinical images and documents that project team demands according to PRP.
组织完成项目评估需要临床资料收集和分析,提供临床方面的评估结轮。

8. To establish and maintain good relationship with clinical experts, hospitals and governments according to PRP and project requirements, therefore, to obtain clinical data and information timely, perform clinical validation smoothly and update legislation and training information in time.
维护与临床专家的关系，保证及时获得专业的临床数据和信息；与测试医院的关系，保证所有测试活动的顺利进行；与相关政府机构的关系，保证及时获得法规更新和培训的信息。

9. To join risk analysis for clinical feedbacks according to Risk Evaluation process.
根据风险评估流程，对所负责产品线的产品在临床使用中反馈问题的进行风险分析。

10. To assume researches about clinical application, image quality optimization and plan, and workflow optimization.
承担并组织相关产品临床应用研究,优化工作流程和方案;开发新的临床应用.优化图像质量的任务
11. To evaluate pertential hospitals, and choose suitable hospitals as good validations ites base on target and content of validations, ensure validations complete smoothly.
按照临床测试的目的对潜在的测试医院进行评估，并选择合适的医院承担测试任务，确保测试的内容和目的为医院所理解，并保证测试的顺利完成

Job Requirements & Skills
岗位要求

1． Education and Professional Background 学历与专业背景
Bachelor degree or above; majored in Medical bioengineering or medical imaging diagnosis
本科或以上。生物医学工程或临床影像诊断相关专业。

2． Work Experiences工作经验
5-years imaging diagnosis or imaging analysis experience in hospital or medical imaging equipment company; Experience in clinical validations required.具有5年以上影像诊断或影像分析和优化工作经验。组织过临床测试工作。

3． Knowledge and Skills知识与技能
1) Equipped with reasonable medical imaging diagnosis knowledge and/or with the workflow of imaging collection and diagnosis. Regulation of hospital also needed. 掌握诊断医学知识或/及临床医生的工作流程；熟悉医院与影像诊断工作相关规章。
2) Knowledge in imaging product principles. Skillful in CT application category.
掌握影像产品结构及原理，熟悉CT产品的临床应用。
3) Knowledge of the progress and trends of imaging products and able to give instruction for product design and update.熟悉影像产品的市场需求和发展方向，能够在工作中对产品的升级和设计起到指导作用。
4) Good English reading and writing ability and fluent in oral English. 出色的英语读写能力，及熟练的口语表达能力。
5) large medical equipment qualification certificate needed. 具有大型医疗设备上岗证。

4．Key Qualifications关键素质
 1 ) Workflow and protocol optimization, engineering or clinical application development and innovation图像和工作流程优化能力, CT相关工程或临床应用开发和创新
2）Equipped with clinical dignosis knowledge and/or clinical workflow
掌握诊断医学知识或/及临床工作流程 举报 分享

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