Overview
DxD Hub is seeking an experienced Data Scientist to support new diagnostics product development and data analytics in software development for Software as a Medical Device (SaMD).
In this role, you will drive the successful execution of diagnostic products in collaboration with external partners.
The ideal candidate should possess a strong background in data science and machine learning; deep learning is highly preferred.
Responsibilities
- Analyze healthcare related data for diagnostic applications; define problems, hypotheses, and analysis plans.
- Develop and optimize algorithms for data analysis, synthesis, visual recognition, object detection, segmentation, and signal pattern recognition, etc.
- Design, execute, and document experiments to validate model assumptions and performance in line with regulatory requirements.
- Conduct feasibility studies and support clinical/analytical validation of AI-based algorithms for diagnostic use.
- Explore and integrate cutting-edge technologies into diagnostic AI solutions, ensuring robustness, reproducibility, and compliance.
- Translate business and clinical needs into data science projects, aligned with regulatory and quality management requirements.
- Collaborate with cross-functional teams (R&D, QA/RA, clinical affairs) to ensure AI models meet regulatory standards (FDA, CE-IVDR, HSA, etc.).
- Prepare and maintain technical documentation, including design history files (DHF), risk assessments, software development lifecycle (SDLC) deliverables, and regulatory submissions.
- Support model deployment under SaMD frameworks, including monitoring, version control, and post-market surveillance.
- Stay current with trends in AI for diagnostics, SaMD regulatory guidance, and international standards.
Requirements
- PhD or Master's degree in a quantitative field (Biomedical Engineering, Mathematics, Statistics, Computer Science, Physics, or related).
- 1-3 years of relevant working experience in AI development.
- Solid background in computer vision, deep learning, and image/signal data analysis algorithms, LLM etc.
- Hands-on experience with Python and major deep learning frameworks (TensorFlow, PyTorch, Keras etc.) and LLM.
- Strong communication skills to explain technical insights to both technical and non-technical stakeholders.
- Ability to work independently within a regulated development environment.
- Model performance evaluation, deployment and lifecycle management experience (MLOps, monitoring, data drift management).
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