Electronics Engineer
hace 3 semanas
As a Senior Electronics Engineer at Inbrain Neuroelectronics, you will play a crucial role in the development and testing of electronic systems for our CNS neurostimulation implant and peripheral equipment. This is a complex active medical device that requires CE mark approval in the EU and FDA approval in the USA.
Key Responsibilities- Lead the design, assembly, and testing of electronic circuits for the implantable CNS neurostimulation system, collaborating closely with software, quality, and regulatory teams.
- Support external partners in the outsourced design, assembly, and testing of electronic circuits for the implantable CNS neurostimulation system.
- Develop, build, and run manual and automated test systems to characterize and verify electronics and embedded systems.
- Qualify, validate, and maintain lab tools and equipment in accordance with 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 technical concepts.
- Perform functional analysis and create system designs that meet 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 electronics and embedded systems against 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 formal product development processes, perform design and phase reviews.
- Follow change request processes.
- 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 a 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 busses and protocols (e.g., I2C, SPI, UART, etc.).
- Familiar with analog design, preferably implant analog design.
- Ability to manage projects mandated to external sub-contractor and manufacturing.
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