• Design & Development: Lead the design, assembly, and testing of electronic circuits for an implantable CNS neuromodulation system.
• Collaboration: Work directly with embedded software, quality, and regulatory teams. Support external partners in outsourced design and testing.
• Testing & Validation: Develop and run manual and automated test systems, and maintain lab tools and equipment according to Good Lab Practices (GLP).
• System Integration: Translate system requirements into hardware and embedded software requirements, and conduct functional analysis and DFMEA.
• Standards & Guidelines: Apply applicable standards (e.g., IEC60601, ISO14971), create test plans, and perform system integration, verification, and validation.
• Project Management: Manage projects with external subcontractors, generate intellectual property, and work with Quality, Regulatory, Clinical, and Project Management teams on product development processes.
• Education: BSc or MSc in Electronics Engineering
• Experience: At least 5 years in a relevant industrial setting (regulated environment, MedTech is a strong plus)
• Specialization: Experience with active implantable medical devices is required
• Skills:
• Strong practical background in electronic hardware and embedded design
• Familiarity with electronic simulation tools (e.g., Spice, Altium, VHDL)
• Knowledge of digital communication busses and protocols (e.g., I2C, SPI, UART)
• Experience with analog design, preferably implant analog design
• Experience with quality control for medical devices (ISO13485) and understanding of Medical Risk Analysis
• Familiarity with DFR/DFM/DFT principles
