1、 根据法规、临床和市场需求，进行产品的工程需求管理，产生系统子系统的需求，确保其一致性、完整性及可操作性。 

According to regulations, clinical and market requirements, the engineering requirements management of products is carried out, and the requirements of system subsystems are generated to ensure their consistency, integrity and operability.

2、 参与系统设计，输出接口规范，评审子系统设计，确保稳健开发。

Participate in system design, output interface specification, review subsystem design to ensure robust development.

3、 与研发团队共同保证产品设计的可靠性、可维护性及易用性，保证产品质量，提高用户满意度。 

To work with R&D team to ensure the reliability, maintainability and ease of use of product design, ensure product quality and improve customer satisfaction.

4、 进行产品生命周期风险管理，负责系统及子系统风险识别、分析、控制、验证，实现符合ISO14971的风险管理活动，保证产品的安全性。

To product life cycle risk management, responsible for system and subsystem risk identification, analysis, control and verification, to achieve risk management activities in line with ISO14971, to ensure product safety.

5、 与研发、实施团队合作，解决设计及安装过程中出现的具体问题，使其与原始设计概念、用户需求保持一致。

To work with R&D and implementation team to solve specific problems in design and installation process, so as to make it consistent with the original design concept and user needs.

6、 支持系统子系统的测试验证及产品确认，保障产品顺利实现。

To test and validation of support system subsystem and product validation to ensure the smooth realization of products.

7、 建立并维护各类文档，为产品注册及市场推广提供相应资料保障。

To establish and maintain all kinds of documents to provide relevant information for product registration and marketing.

8、 其他未尽事宜。

Other tasks assigned by leader.

 

任职要求：

1、本科及以上学历，理工科类相关专业。

Bachelor’s degree or above, major in science and technology or related.

2、3年以上医疗产品系统工程师相关经验，或3年医疗产品设计开发经验，放疗设备相关经验优先。

Over 3 years system engineering work experience for medical product development, and work experience with radiotherapy system is preferred.

3、熟悉医疗法规标准和质量开发流程

Familiar with medical regulatory and quality process.

4、具备良好的解决问题及团队合作能力。

Good coordination ability and teamwork spirit.

5、具有良好的英文听、说、读、写能力。

Good command of English in listening, speaking, reading and writing.