About Cefaly Technology
Cefaly Technology is a pioneering medical device company headquartered in Liège, Belgium. We develop and manufacture the Cefaly device – the world’s first FDA-cleared external neurostimulation device for the treatment and prevention of migraines. Our products combine advanced electronics, firmware, and clinically validated neuroscience to improve the lives of millions of migraine sufferers worldwide. We are a fast-growing, innovation-driven team committed to regulatory excellence and patient safety.
Role Summary
We are seeking a talented and detail-oriented R&D Director to join our team. In this role, you will be responsible for designing, developing, testing, and maintaining the hardware and embedded firmware of our neurostimulation medical devices. You will work closely with cross-functional teams including software, mechanical engineering, quality assurance, and regulatory affairs to bring safe, effective, and compliant products to market. A strong understanding of medical device regulations (EU MDR, FDA) and the ability to produce thorough documentation are essential.
Key Responsibilities
- • Design and develop electronic hardware for medical-grade neurostimulation devices, including schematic design, PCB layout review, and component selection
• Write, debug, and optimize embedded firmware (C/C++) for microcontrollers used in Cefaly devices
• Plan and execute hardware verification and validation testing (V&V) in accordance with IEC 62304, IEC 60601-1, and other applicable standards
• Collaborate with the regulatory affairs team to prepare and maintain technical documentation required for CE marking (EU MDR 2017/745) and FDA 510(k) submissions
• Author and maintain design history files (DHF), risk analysis documents (ISO 14971), and design and development plans
• Participate in design reviews, FMEA sessions, and root cause analyses for product non-conformances
• Support production and manufacturing teams with hardware-related troubleshooting and process improvements
• Evaluate and qualify new components, suppliers, and manufacturing processes
• Stay current with evolving regulatory requirements, industry standards, and best practices in medical device hardware development
• Contribute to continuous improvement of the Quality Management System (QMS) under ISO 13485
Required Qualifications
- • Master’s degree in Electrical Engineering, Electronics, Embedded Systems, or a related field
• 4–7 years of professional experience in hardware development, with 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 (e.g., Altium Designer, KiCad, or equivalent)
• Solid understanding of analogue and digital circuit design, signal processing, and power management
• Demonstrated experience with medical device regulatory standards: IEC 62304, IEC 60601-1, ISO 14971, ISO 13485
• Proven ability to produce high-quality regulatory and technical 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 strong asset
Nice to Have
- • Experience with Bluetooth Low Energy (BLE) or other wireless communication protocols in medical devices
• Familiarity with neurostimulation or wearable medical device technology
• Experience with version control systems (Git) and CI/CD pipelines for firmware
• Knowledge of cybersecurity requirements for medical devices (IEC 81001-5-1)
• Prior involvement in notified body audits or FDA inspections
What we offer
• Competitive compensation commensurate with experience
• Work at a mission-driven medical device company whose products improve patients' lives every day
• Collaborative, international team with colleagues across Belgium, the US, and beyond
• Hybrid-friendly working environment based at our Liège headquarters
• Meaningful ownership of critical systems from day one
• Opportunities for growth as CEFALY's technology footprint continues to expand
• 20 days of annual leave plus 10 statutory holidays
• Meal vouchers
• 38- hour work week
• Contributions to the sectoral supplementary pension and hospitalization insurance plan (DKV – covering all family members)
• One day of seniority leave for each complete five-year period of service
• 13th month salary and bonus
• Telecommunication allowance
• Remote work / office expense allowance