Responsibilities 职责:
1.Responsible of Electronics design (software and hardware, software is the most important) for new products development of electro-medical devices.
负责医疗器械新产品的电子部分的设计开发工作(包括软件和硬件,软件为主),包括原理图设计、PCB设计、DFMEA及设计文档的输出等;
2.Responsible for EMC and safety certification test of new and improved products, engineering
sample test and production test guidance to ensure product design meets technical requirements;.
负责新产品及改良产品的EMC及安全测试认证、工程样板试验以及生产测试指导,确保产品设计符合技术要求;
3.Prepare all technical documentations for the technical file of medical device following the internal procedures accordingly with medical standards ISO13485 and MDR requirements.
负责所有医疗器械技术文件要求相关的技术文档,确保相关的内部流程符合ISO13485、MDR和FDA等的要求;
4.Provide technical support for production issue, supplier quality improvement and others.
提供其他的技术支持:如生产问题解决,供应商质量改善,客诉分析等。
...任职要求
1.University degree in electronic engineering or similar technical field.
电子工程或类似领域大学毕业
2.3+ ye...