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, , 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
- 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.
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