Principal Clinical Scientist, Medical Devices & AI
Core
Own the scientific evidence pathway for medical devices, AI algorithms, and Software as a Medical Device (SaMD) from early concepts through clinical validation and regulatory submissions.
Role type
Principal Clinical Scientist (Medical Devices & AI)
Builds
Clinical evidence packages, study protocols, and scientific reports for regulatory review and product development.
Domain
Healthcare technology, Medical Devices, Artificial Intelligence, Clinical Research
Deliverable
production ML models
Required skills
Clinical study design and protocol development, Statistical analysis and sample size calculation, AI/ML model evaluation and validation, Regulatory science (FDA, EU MDR, ISO 14155), Python or R programming, Quantitative judgement on diagnostic accuracy, Scientific leadership and mentorship
Preferred skills
Medical device or diagnostic validation experience, Physiological sensing or medical imaging expertise, Multi-site international clinical study experience, Academic and clinical partner collaboration