R&D Engineer - Medical Devices (H/F/X)

Description

On behalf of a pioneering, fast-growing company in the electronic medical devices sector (Liège region), we are looking for a talented and detail-oriented R&D Engineer to strengthen its technical team. You will join an innovative company whose products combine advanced electronics, firmware and clinically validated neuroscience, serving patient health and safety. In this role, you are responsible for designing, developing, testing and maintaining the hardware and embedded firmware of next-generation medical devices. You design the electronics (schematic design, PCB layout review, component selection) and write, debug and optimise embedded firmware in C/C++ on ARM microcontrollers. You plan and execute hardware verification and validation (V&V) testing in accordance with IEC 62304, IEC 60601-1 and other applicable standards. Working closely with regulatory affairs, you prepare and maintain the technical documentation required for CE marking (EU MDR 2017/745) and FDA 510(k) submissions: design history files (DHF), risk analyses (ISO 14971) and development plans. You take part in design reviews, FMEA sessions and root cause analyses. You collaborate daily with cross-functional teams (software, mechanical, quality assurance, regulatory) in a demanding environment focused on quality and patient safety. You also support production on hardware-related matters, qualify new components and suppliers, and contribute to the continuous improvement of the Quality Management System (ISO 13485). From day one, you enjoy meaningful ownership of critical systems.

Profile sought

• Master's degree in Electrical Engineering, Electronics, Embedded Systems or a related field
• 4 to 7 years of experience in hardware development, including at least 2 years in the medical device industry
• Strong proficiency in embedded firmware development (C/C++) on ARM-based or similar microcontroller platforms
• Hands-on experience with PCB design tools (Altium Designer, KiCad or equivalent)
• Solid understanding of analogue and digital circuit design, signal processing and power management
• Knowledge of regulatory standards: IEC 62304, IEC 60601-1, ISO 14971, ISO 13485
• Proven ability to produce high-quality technical and regulatory documentation (design files, test protocols, risk analyses)
• Experience with hardware V&V testing, EMC testing and environmental testing
• Familiarity with EU MDR 2017/745 and/or FDA regulatory pathways (510(k), De Novo)
• Fluent in English; French and/or Dutch is a real asset
• Nice to have: BLE and wireless communication, wearable medical devices, Git and CI/CD, cybersecurity (IEC 81001-5-1), involvement in notified body audits or FDA inspections