Process Engineer (Medical Device Manufacturing)

About the role

Nyxoah is seeking a Process Engineer to lead the transition of its implantable medical devices from R&D to large‑scale production. Based in Liège, the role focuses on designing, validating and scaling electronic assembly processes while ensuring compliance with medical‑device regulations.

Key responsibilities

• Design and optimize manufacturing processes and assembly workflows for active implantable devices, focusing on electronic assemblies, miniaturized components, PCB integration and electro‑mechanical systems.
• Lead process validation activities, planning and executing IQ, OQ and PQ protocols for electronics and assembly operations.
• Apply DFM and DFA principles to ensure efficient transfer from development to scalable production while maintaining quality and reliability.
• Select, implement and commission high‑precision manufacturing equipment and automation systems for electronic and implant assembly.
• Define User Requirement Specifications for new equipment and collaborate with suppliers to meet process capability, regulatory and quality requirements.
• Develop preventive maintenance and calibration strategies for production equipment and test systems to maximize uptime and process stability.
• Act as technical lead for equipment and process issues, conducting structured troubleshooting and root‑cause investigations.
• Drive Lean Manufacturing and Six Sigma initiatives to improve yield, reduce variability and enhance overall process efficiency.

Required profile

• Proven experience in electronics‑focused process design for medical‑device manufacturing.
• Hands‑on knowledge of ISO 13485 and FDA 21 CFR Part 820 compliance requirements.
• Experience leading process validation (IQ, OQ, PQ) and equipment qualification activities.
• Ability to work cross‑functionally with R&D, quality and supplier teams.
• Strong analytical and problem‑solving skills applied to manufacturing challenges.

Required skills

• Electronics assembly
• PCB integration
• Electro‑mechanical system design
• Process validation (IQ, OQ, PQ)
• Design for Manufacturing (DFM)
• Design for Assembly (DFA)
• Lean Manufacturing
• Six Sigma methodology
• Equipment selection and commissioning
• Preventive maintenance and calibration
• Root‑cause analysis
• ISO 13485 compliance
• FDA 21 CFR Part 820 compliance