Clinical Validation Engineer

In the fight against breast cancer every medical image is an opportunity: to unlock insight to uncover risk to embody health to empower life. ScreenPoints 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 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.

Your responsibilities:

• Clinical validation and verification: Define and execute clinical performance verification and validation activities using independent datasets ensuring reliable and reproducible evaluation of algorithm performance.
  
• Tooling and automation: Design implement and maintain tooling and pipelines for automated and reproducible testing supporting clinical evaluation PMCF activities and regulatory submissions.
  
• Performance monitoring and post-market support: Generate document and monitor algorithm performance throughout the product lifecycle. You support post-market activities including customer feedback analysis and contributing to training materials related to algorithm performance.
  
• Cross-functional collaboration: Work closely with Innovation Commercial Engineering and Product teams to align validation strategies with product development and regulatory requirements.
  
• Continuous improvement: Contribute to improving validation processes in terms of scalability robustness and coverage ensuring efficient and future-proof ways of working.
  

Job requirements
You are a technically strong and detail-oriented professional who enjoys working with data and translating analysis into meaningful clinical insights. You are comfortable working in a cross-functional environment and contributing to structured processes within a quality-driven organization. Furthermore you have:

• A Masters 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 & 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
  

About us
ScreenPoint Medical is a leading company that develops and markets breast image analysis and cutting-edge machine learning applications and services. Our product Transpara improves breast cancer survival rates by detecting cancers earlier so that treatment can be more effective and less invasive.

Do you want to help us build an innovative solution to improve health worldwide And do you want to be part of an ambitious and fast-growing team who help you develop your career further Please apply using the application button.

Providing a Certificate of Conduct (VOG) or background check is part of our application procedure. Questions about the contents of the vacancy or the recruitment process at ScreenPoint Medical Please send an email to . Applications through this email address will not be reviewed.

Required Experience:

Manager