On behalf of our client, a fast-growing MedTech innovator, we are seeking a talented Software Engineer with expertise in AI and Software as a Medical Device (SaMD).
Our client develops regulated AI-powered medical software designed to improve patient outcomes and support clinicians in delivering world-class healthcare. This is an excellent opportunity to join a mission-driven team working at the forefront of digital health innovation in Belgium.
The Role
As a Software Engineer, you will be instrumental in designing, building, and maintaining compliant, production-ready SaMD solutions that integrate advanced AI/ML models. You will work in a cross-functional team including product managers, data scientists, QA, and regulatory experts to deliver high-quality medical AI products in line with international standards.
Key Responsibilities
* Design, develop, and maintain software components for AI-powered SaMD products.
* Ensure software traceability and compliance with IEC 62304, ISO 13485, and MDR/FDA standards.
* Collaborate with AI/ML teams to integrate validated models into production-ready software.
* Contribute to system architecture, ensuring scalability, reliability, and compliance.
* Write automated tests and validation frameworks to support audits and regulatory submissions.
* Participate in agile delivery practices, code reviews, and continuous improvement initiatives.
Requirements
Technical Skills
* Strong programming skills in Python, JavaScript/Node.js, or C++.
* Hands-on experience with AI/ML frameworks (e.g., TensorFlow, PyTorch).
* Familiarity with cloud platforms (AWS, Azure, GCP), containerisation (Docker, Kubernetes), and CI/CD pipelines.
* Solid experience in software testing and automation.
Domain Knowledge
* Previous experience working on SaMD or regulated healthcare software projects.
* Knowledge of IEC 62304, ISO 13485, and risk management (ISO 14971).
* Experience with integrating or deploying AI/ML in clinical products (advantageous).
Soft Skills
* Strong analytical and problem-solving mindset.
* Clear communication skills in English (Dutch or French is an asset).
* Collaborative, quality-focused, and detail-oriented.
What’s on Offer
* Salary package of €55,000 – €75,000 with bonus potential.
* Healthcare and wellness benefits.
* 30 days annual leave + public holidays.
* Flexible hybrid working model.
* Ongoing training and professional development budget.
* Opportunity to directly influence the future of AI in healthcare.
How to apply
Please submit your CV ensuring that all the requirements highlighted above are clearly demonstrated.
Depending on the volume of applications received, we may not be able to contact you if the requirements are not clearly stated on your CV.