We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Job Title: Process Engineer
Reporting to: Engineering Manager
Employment: Full-time
As a Process Engineer at Nyxoah, you will be a key player in bridging the gap between R&D and large-scale production. You will be responsible for designing, implementing, and optimizing manufacturing processes and equipment for our implantable medical devices. Your goal is to ensure high-quality production, scalability, and full compliance with international medical regulations (ISO 13485, FDA 21 CFR Part 820).
Process Design: Design and improve manufacturing processes, assembly lines, and workflows for active implantable medical devices.
Lead Process Validation activities, including the creation and execution of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.
Ensure Design for Manufacturing (DFM) principles are integrated into product development to facilitate smooth scale-up.
Equipment & Technology Management
Equipment Selection & Commissioning: Lead the selection, procurement, and commissioning of new production equipment and automated systems tailored for high-precision implant manufacturing.
Troubleshooting: Act as the technical lead for equipment-related issues, performing deep-dive troubleshooting to maintain continuous production flow.
Quality & Continuous Improvement
Identify and implement Lean Manufacturing and Six Sigma initiatives to reduce waste, improve yields, and lower manufacturing costs.
Compliance: Ensure all processes and equipment comply with Quality Management System (QMS) standards and regulatory requirements.
Risk Management: Lead root cause analysis (CAPA) and risk assessments (PFMEA) for process and equipment deviations.
Master’s degree in engineering (Mechanical, Biomedical, Electronics, or Materials Science).
Experience: At least 3 years of experience in process engineering, preferably within a highly regulated industry (Medical Devices, Pharma, Aerospace, etc.). Experience with implants or active electronics is a major plus.
Proven experience in equipment integration, automation, or tooling design, preferably within a cleanroom environment (ISO Class 7 or 8).
Technical Skills: Proficiency in CAD software (e.g., SolidWorks), statistical analysis (Minitab), and a strong mechanical aptitude to interface with PLC systems or robotics.
Languages: Excellent command of English (written and spoken). Proficiency in French or Dutch is an advantage.
The opportunity to work on a life-changing technology that treats Sleep Apnea.
A dynamic, international, and entrepreneurial environment where you can truly make an impact.