东莞招聘

Job Description
HC-Clinical Expert

The purposes of this position are:

岗位目的

To lead clinical related design input, validation and clinical validation for new product creation and existing product improvement/updated projects based on CT product ; to develop clinical related function and/or workflow; to optimize protocol and parameters for improving product performance; to perform costumer acceptance test (CAT) in clinical circumstances based on system design input; to give training and support Application , Service and Sales personnel;

职位及人数: 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.Clinical science in Philips: work/project communication

2.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

3.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

4.Imaging Department of hospital: to complete CAT, SFDA clinical trial etc. according to CAT plan or SFDA clinical trial protocol; to complete clinical validation according to ARS; to complete clinical evaluation report according to CE legislation.

临床测试机构影像科室：按照计划完成可接受性测试；按方案完成SFDA临床测试；按ARS完成临床评价活动；按CE的要求完成临床评估报告。

5.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

Key Areas of Responsibility：

主要工作职责

(Identify key responsibilities in rough order of importance. Focus on the results that areexpected from the job. For each statement, please set out the target in specific area or scope, the expected final results .

根据大致的重要度依次列出主要的工作职责. 重点放在期望此岗位产生的结果.对每项陈述请指明工作领域或工作框架中的任务,及所产生的最终结果）

To study clinical tehnology development trend, and initialize clinical feature roadmap for CT product

Provde clinical application requirements to engineering team

Validate the clinical features in the product, to ensure the product meet the clinical use

organize, implement, monitor and complete SFDA clinical trial according to SFDA process and acquire related clinical data and documents.

To guide risk analysis for clinical feedbacks according to Risk Evaluation process.

To orgnize clinical application-releate research, optimize image quality and workflow.

Job Requirements & Skills

岗位要求

·Education学历: 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。

·Experience工作经验：5-year imaging diagnosis or imaging analysis experience in hospital or medical imaging equipment company; At least middle level academic, associate or above professor or same level preferred.

5年以上影像诊断或影像分析和优化工作经验。中级以上临床影像或医学工程方面职称。

·Competency and Skills 能力和技能

-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。

- Knowledge in imaging product principles. Skillful in CT product category.

- 掌握影像产品结构及原理，在CT产品领域灵活应用。

- Familiar with clinical evaluation laws and regulations. Able to ensure the compliance of the clinical evaluations with the regulations

- 掌握与临床测试相关法律法规，保障临床测试工作符合相关法规要求。

- Knowledge of the progress and trends of imaging products and able to give instruction for product design and update

- 掌握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。

- 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。

- Better to have large medical equipment qualification certificate

- 期望具有大型医疗设备上岗证。

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