ABOUT NYXOAH Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by an external wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing the burden of OSA. For more information, visit .Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.Job Title: Process EngineerLocation: Liège (Légiapark)Reporting to: Engineering ManagerEmployment: Full-timeAs 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).Key ResponsibilitiesProcess Development & ValidationProcess Design: Design and improve manufacturing processes, assembly lines, and workflows for active implantable medical devices.Validation & Verification: Lead Process Validation activities, including the creation and execution of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.Scalability: Ensure Design for Manufacturing (DFM) principles are integrated into product development to facilitate smooth scale-up.Equipment & Technology ManagementEquipment Selection & Commissioning: Lead the selection, procurement, and commissioning of new production equipment and automated systems tailored for high-precision implant manufacturing.Technical Specifications: Define User Requirement Specifications (URS) for new machinery and collaborate with external vendors to ensure equipment meets technical and safety standards.Maintenance & Calibration: Develop and oversee preventive maintenance schedules and calibration programs to ensure equipment reliability and minimize downtime.Troubleshooting: Act as the technical lead for equipment-related issues, performing deep-dive troubleshooting to maintain continuous production flow.Quality & Continuous ImprovementOptimization: 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.Documentation: Create and maintain technical documentation, including Work Instructions (WI) and Standard Operating Procedures (SOPs).Required QualificationsEducation: Master’s degree in engineering (Mechanical, 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.Equipment Expertise: Proven experience in equipment integration, automation, or tooling design, preferably within a cleanroom environment (ISO Class 7 or 8).Regulatory Knowledge: Strong understanding of ISO 13485 and FDA 21 CFR Part 820 regulations.Technical Skills: Proficiency in CAD software (e.G., SolidWorks), statistical analysis (Minitab), and a strong mechanical aptitude to interface with PLC systems or robotics.Mindset: A "scale-up" mentality—you are proactive, flexible, and comfortable working in a fast-paced, evolving environment.Languages: Excellent command of English (written and spoken). Proficiency in French or Dutch is an advantage.What We OfferThe 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.Significant career growth opportunities as the company scales its global operations.A competitive salary and benefits package.We thank all applicants for their interest in our organization, however; only those selected foran interview will be contacted.Nyxoah is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other protected status in accordance with applicable laws. xdkqlui All employment decisions are based on qualifications, merit, and business needs.