北京招聘

Primary Function of Position:

The Clinical Development Engineer implements design validation, human factor/usability engineering of production transfer project. As the key contributor for product localization, support R&D and preclinical activities for product launching.

临床开发工程师主要负责生产转移项目的设计确认、可用性工程等，作为产品本土化的重要环节，在产品上市前阶段，支持研发以及临床前相关活动。

This position requires passion for clinical technology along with being an agile learner and possessing a can-do attitude.

本职位需要应聘者对临床技术有热情，且对未知领域有“can-do”的态度和敏捷学习的能力。

Roles and Responsibilities:

? As the contributor of robotic surgical system localization team, be responsible for clinical engineering activities, including design validation, IFU & labeling validation, usability engineering, etc.

作为手术机器人系统本地化团队的成员，负责临床工程方面的活动，包括设计确认，IFU&标签确认，可用性工程等

? Be responsible for study protocol finalize & release, onsite support study implementation, collate study result and draft report.

负责实验方案的定稿、发布，对实验实施进行现场支持，整理实验结果并起草实验报告

? Takes ownership of preclinical study coordination from Intufosun side, communicate with ISI project team, R&D & CDE contact window to achieve win-win goal.

作为直观复星临床前研究/实验的主导者，与ISI项目团队，研发以及CDE对接人保持沟通，以达成双方共赢

? Docking the third-party animal lab, prepare for study execution, check and confirm environment to meet requirement.

对接第三方动物实验室，为实验进行准备工作，检查并确认实验室环境以符合需求

? As technical backup, support any other preclinical study of local original /cooperation product in the future.

作为技术储备人员，支持将来本地原研/合作产品的临床开发工作

? Other reasonable assigned duties.

其他合理分配的职责

Skill/Job Requirements:

? 2~3 years in Surgery Clinical technical support, very familiar with surgical product (system, instrument, accessory) 在外科临床技术支持有2至3年经验，深入了解外科手术相关产品（系统、器械、耗材）

? Basic knowledge of medical device risk management, DHF, design V&V, etc. 对医疗器械风险管理，设计历史，开发验证及确认有基本了解

? Strong problem solve ability, including problem finding, reporting, seeking solution. 较强的问题解决能力,包含发现问题，报告问题，寻找解决方案。

? NPI or localization engineering experience as a team member in international project is a plus. 作为跨国项目的团队成员，在新产品导入或产品本土化方面有经验是加分项

? Any experience or insights for Human factor/usability engineering is a plus. 对人因工程/可用性工程有所了解是加分项

? Willing to travel愿意出差

? Fluent in English 英语流利

Intuitive Surgical is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery with presence in more than 60 countries around the world.
  
Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd. is the Joint Venture between Intuitive Surgical and Fosun Pharma- a subsidiary of Fosun International, a leading Pharma and Medical Device Company in China.
  
The intent of the Company is to research, develop and manufacture innovative, robotic-assisted catheter-based Medical Devices.