职责描述: 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+ years experiences in electronic devices development or production, Familiar with PC development is preferred. 3年以上电子产品的开发或生产经验,熟悉单片机、上位机开发的优先考虑; 3.Highly organized, with proven ability in the delivery of project needs working within strict time constraints. Would be expected to take a pro-active approach to identification & mitigation of project risk so as to deliver high quality products, often to challenging timescales. 做事有条理,有能经证实的项目工作经验,能适应在非常紧张的时间内完成项目设计和变更。能有预见性的在设计开始前进行项目风险预估并予以安排适当的处理措施 4.Ability to work independently. Good at problem solving techniques, project leading experience is plus 能独立工作。问题分析和处理能力强,有带项目经验优先考虑 5.Fluent English both spoken and written 英语读写有一定基础 6.Good team player and have good interpersonal communication skill. 人际沟通能力强,善于团队合作