Hardware Developer

ph3About Cefaly Technology /h3 pCefaly 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. /p h3Role Summary /h3 pWe are seeking a talented and detail-oriented RD 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. /p h3Key Responsibilities /h3 ul liDesign and develop electronic hardware for medical-grade neurostimulation devices, including schematic design, PCB layout review, and component selection /li liWrite, debug, and optimize embedded firmware (C/C++) for microcontrollers used in Cefaly devices /li liPlan and execute hardware verification and validation testing (VV) in accordance with IEC 62304, IEC 60601-1, and other applicable standards /li liCollaborate with the regulatory affairs team to prepare and maintain technical documentation required for CE marking (EU MDR 2017/745) and FDA 510(k) submissions /li liAuthor and maintain design history files (DHF), risk analysis documents (ISO 14971), and design and development plans /li liParticipate in design reviews, FMEA sessions, and root cause analyses for product non-conformances /li liSupport production and manufacturing teams with hardware-related troubleshooting and process improvements /li liEvaluate and qualify new components, suppliers, and manufacturing processes /li liStay current with evolving regulatory requirements, industry standards, and best practices in medical device hardware development /li liContribute to continuous improvement of the Quality Management System (QMS) under ISO 13485 /li /ul h3Required Qualifications /h3 ul liMaster’s degree in Electrical Engineering, Electronics, Embedded Systems, or a related field /li li4–7 years of professional experience in hardware development, with at least 2 years in the medical device industry /li liStrong proficiency in embedded firmware development (C/C++) on ARM-based or similar microcontroller platforms /li liHands‑on experience with PCB design tools (e.g., Altium Designer, KiCad, or equivalent) /li liSolid understanding of analogue and digital circuit design, signal processing, and power management /li liDemonstrated experience with medical device regulatory standards: IEC 62304, IEC 60601-1, ISO 14971, ISO 13485 /li liProven ability to produce high‑quality regulatory and technical documentation (design files, test protocols, risk analyses) /li liExperience with hardware VV testing, EMC testing, and environmental testing /li liFamiliarity with EU MDR 2017/745 and/or FDA regulatory pathways (510(k), De Novo) /li liFluent in English; French and/or Dutch is a strong asset /li /ul h3Nice to Have /h3 ul liExperience with Bluetooth Low Energy (BLE) or other wireless communication protocols in medical devices /li liFamiliarity with neurostimulation or wearable medical device technology /li liExperience with version control systems (Git) and CI/CD pipelines for firmware /li liKnowledge of cybersecurity requirements for medical devices (IEC 81001-5-1) /li liPrior involvement in notified body audits or FDA inspections /li /ul h3What

we offer
/h3 ul liCompetitive compensation commensurate with experience /li liWork at a mission‑driven medical device company whose products improve patients' lives every day /li liCollaborative, international team with colleagues across Belgium, the US, and beyond /li liHybrid-friendly working environment based at our Liège headquarters /li liMeaningful ownership of critical systems from day one /li liOpportunities for growth as CEFALY's technology footprint continues to expand /li li20 days of annual leave plus 10 statutory holidays /li liMeal vouchers /li li38
- hour work week /li liContributions to the sectoral supplementary pension and hospitalization insurance plan (DKV – covering all family members) /li liOne day of seniority leave for each complete five‑year period of service /li li13th month salary and bonus /li liTelecommunication allowance /li liRemote work / office expense allowance /li /ul /p