Hybrid/Remote MedTech R&D Engineer - Embedded Hardware

CEFALY Technology; Luik; Hybride; 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

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.