As a Sr Electronics Engineer, you will be contributing to the development and testing of electronic systems. These electrical systems are part of a complex CNS neurostimulation implant and its peripheral equipment. This active medical device will be released in both the EU, requiring CE mark according to the MDR, and in the USA, requiring FDA approval. The Sr Electronics Engineer will investigate, develop, design, and test electronic components, assemblies, and systems. Main Responsibilities Lead the design, assembly, and testing of electronic circuits that are part of an implantable CNS neurostimulation system, in direct collaboration with the (embedded) software, quality, and regulatory teams. Support our external partners in the outsourced design, assembly, and testing of electronic circuits that are part of an implantable CNS neurostimulation system. Develop, build, and run manual and automated test systems to characterize and verify our electronics and embedded systems. Qualify, validate, and maintain lab tools and equipment, in the framework of Good Lab Practices (GLP). Support and lead the development team in translating system requirements into hardware and embedded software requirements, and into interface definitions. Assess the technical feasibility of and contribute to the technical concepts. Perform functional analysis and create system designs that meet the requirements. Perform design failure mode and effect analysis (DFMEA) on designs. Apply applicable standards and guidelines (e.g., IEC60601, ISO14971). Create test plans to verify our electronics and embedded systems against the product and manufacturing requirements. Perform system integration, verification, and validation. Maintain traceability between requirements and test records/reports. Initiate and contribute to design, technical, and milestone reviews. Generate intellectual property. Understand DFR/DFM/DFT (Design for Reliability, Design for Manufacturing, and Design for Test), including concept engineering, modeling, analysis, sensitivity, and stress analysis. Work intensively with Quality, Regulatory, Clinical, and Project Management on the formal product development processes, and perform design and phase reviews. Follow change request processes. Your Profile BSc or MSc in Electronics Engineering with at least 5 years of work experience in a relevant industrial setting (regulated environment, MedTech is a strong plus) with proven experience executing a full development cycle. Experience in developing multidisciplinary medical devices is a plus. Strong practical engineering background in electronic hardware and embedded design for commercial production. Familiar with electronic simulation and design methodologies and tools (e.g., Spice, Altium, VHDL, etc.). Familiar with digital communication buses and protocols (e.g., I2C, SPI, UART, etc.). Familiar with analog design, preferably implant analog design. Ability to manage projects mandated to external subcontractors and manufacturing.
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