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负责医疗产品电气组件的设计、开发、测试与维护,涵盖电源与控制电路板、电路接线图及电气安全概念。需与系统、软件、质量等多部门紧密协作,确保符合CE、FDA、MHLW等国际法规要求。
Development, implementation, construction and testing of electrical components and for medical products, which represent state-of-the-art technology. The job holder closely collaborates with stakeholders across department and operational structures, particularly with engineers from other groups such as systems engineering, quality engineering, software development but also regulatory affairs and quality management. Focus is on delivering innovative solutions that meet customer requirements as well as regulatory requirements, particularly those related to safety and effectiveness. The deliverables contribute to increasing the competitiveness and commercial success of Dornier MedTech and its subsidiaries. Solutions are provided in a cost- and time-efficient manner and by strong collaboration with stakeholders across department and operational structures.
Specific Responsibilities: Development and implementation of power and control electronic boards for complex medical devices. Creation of electrical circuit and wiring diagrams for complex medical devices. Development and implementation of electrical safety concepts to assure product functional safety. Implementation and execution of concepts for product cost reduction. Collection and determination of technical requirements and specifications. Create component and system specifications and other quality related documents such as risk analysis, DFMEA, test and verification reports, etc. in compliance with international requirements (CE, FDA, MHLW). Perform verification tests to verify electrical components and product requirements. Maintain products and systems to ensure stable and reliable operations as part of the product lifecycle management process. Support of troubleshooting electrical-related issues in production. Performing of engineering tasks during setup and start-up of prototypes. As needed, coordinate, organize, and track engineering tasks on a task- or project-specific basis. Assisting the project management with the planning of engineering-related tasks. Representation of the Engineering department in project team meetings. Coordinate and work with third-party suppliers and contractors. Monitoring of technological trends in electronics, including reviews of competitors' technology.
Master's degree in science and engineering with experience in R&D. Specialization in electrical engineering. At least 7 years of experience in the development of electrical devices, preferably medical systems. Advanced knowledge of electronics (power-, digital-, analog- and microprocessor technology). Experienced in design and development of power and digital electronic boards. In-depth knowledge of EMI/EMC design principles and electrical safety requirements. Experience in creating electrical schematics and circuit diagrams. Experience working with PC-controlled systems. Experienced in creating technical reference documentation. Kno