Your mission
As a Sr Electronics Engineer you will be contributing to the development and test of electronic systems. These electrical systems are part of a complex CNS neuromodulation 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
Main responsibilities
- Lead the design, assemble and test electronic circuits that are part of an implantable CNS neuromodulation system, in direct collaboration with the (embedded) software, quality and regulatory teams
- Support our external partners in the outsourced design, assembly and test of electronic circuits that are part of an implantable CNS neuromodulation 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, modelling, analysis, sensitivity, and stress analysis.
- Work intensively with Quality, Regulatory, Clinical and Project Management on the formal product development processes, perform design and phase reviews.
- Follow change request processes.