R&D Engineer

CEFALY Technology; Luik; Sur place; EUR 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Hybrid-friendly working environment

20 days of annual leave + 10 holidays

13th month salary and bonus

Remote work / office expense allowance

Telecommunication allowance

Pension and hospitalization insurance

Résumé du poste

Cefaly Technology, a Liège-based medical device company, seeks an R&D Director to lead hardware and embedded firmware development for neurostimulation devices. You’ll collaborate with software, mechanical, quality assurance, and regulatory teams to ensure safe, compliant products.

A strong background in EU MDR and FDA pathways is essential. The role requires a Master’s in Electrical/Embedded Systems, 4–7 years in hardware development (2+ in medical devices), and leadership capabilities.

Qualifications

• Master's degree in Electrical/Embedded Systems or related field.
• 4–7 years hardware development experience, at least 2 years in medical devices.
• Proficiency in embedded C/C++ on ARM microcontrollers.
• Hands-on PCB design in Altium KiCad or equivalent.
• Strong analog/digital circuit design and power management knowledge.
• Experience with medical device regulatory standards: IEC 62304, IEC 60601-1, ISO 14971, ISO 13485.
• Proven ability to produce regulatory and technical documentation.
• Experience with hardware V&V testing, EMC and environmental testing.
• Familiarity with EU MDR 2017/745 and FDA pathways (510(k)).
• Fluent in English; French and/or Dutch is a plus.

Responsabilités

• Design and develop electronic hardware for medical-grade neurostimulation devices.
• Write, debug, and optimize embedded firmware (C/C++) for healthcare MCUs.
• Plan and execute hardware V&V testing per IEC 62304 and IEC 60601-1.
• Prepare and maintain CE marking and FDA 510(k) documentation.
• Maintain DHF, ISO 14971 risk analyses and design development plans.
• Participate in design reviews, FMEA sessions, and root-cause analyses.
• Support production with hardware troubleshooting and process improvements.
• Evaluate components, suppliers, and manufacturing processes.
• Stay current with regulatory requirements and medical device standards.
• Contribute to continuous improvement of the QMS under ISO 13485.

Connaissances

Embedded firmware

ARM MCUs

PCB design

Regulatory knowledge

V&V testing

Documentation

Electrical circuit design

EMC testing

Regulatory standards (EU MDR / FDA)

English proficiency

Formation

Master’s degree in Electrical/Embedded Systems

Outils

Altium Designer

KiCad

Git

CI/CD for firmware

Description du poste

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