Clinical Validation Engineer, Nijmegen

In the fight against breast cancer, every medical image is an opportunity: to unlock insight, to uncover risk, to embody health, to empower life. ScreenPoint’s Transpara Breast AI delivers unmatched precision for breast radiologists and helps define personalized care pathways for every woman we serve. Make your mark as part of The Breast AI Company.We are looking for a Clinical Validation Engineer to strengthen our QA team and play a key role in validating the clinical performance of our AI algorithms. In this role, you will be responsible for designing, executing, and maintaining clinical verification and validation activities, ensuring our products meet the highest standards of quality, safety, and regulatory compliance.You will work closely with Innovation, Engineering, Product Management, and Commercial teams to translate algorithm performance into robust clinical evidence, supporting both pre‑market certification and post‑market monitoring. This role combines technical depth, analytical thinking, and cross‑functional collaboration in a highly regulated MedTech environment.Responsibilities

Define and execute clinical performance verification and validation activities using independent datasets, ensuring reliable and reproducible evaluation of algorithm performance. Design, implement, and maintain tooling and pipelines for automated and reproducible testing, supporting clinical evaluation, PMCF activities, and regulatory submissions.Generate, document, and monitor algorithm performance throughout the product lifecycle, supporting post‑market activities, including customer feedback analysis and contributing to training materials related to algorithm performance. Work closely with Innovation, Commercial, Engineering, and Product teams to align validation strategies with product development and regulatory requirements.Contribute to improving validation processes in terms of scalability, robustness, and coverage, ensuring efficient and future‑proof ways of working. Job Requirements

A Master’s degree in Computer Science, Data Science, or a related field. Strong programming and analytical skills, with the ability to work with large datasets. Proven knowledge of Python and Bash. Experience in data analysis and validation, preferably within medical imaging. Strong communication skills in English, both written and verbal.A structured way of working and strong documentation skills. Preferred Qualifications

Experience as a Data Scientist in the medical imaging domain. Familiarity with statistical analysis tools and methodologies. Experience with Docker, git, slurm, C++. Experience working within a Quality Management System. Experience in a regulated environment such as MedTech, including preparation and submission of documentation to regulatory bodies such as the FDA and DEKRA.

#J-18808-Ljbffr