Senior R&D Clinical Engineer
Core
Define clinical requirements, develop anatomical models, and perform verification/validation testing for structural heart medical devices.
Role type
Senior R&D Clinical Engineer (Structural Heart)
Builds
Structural heart therapies (MitraClip, TriClip) and novel device features
Domain
Healthcare / Medical Devices / Structural Heart
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical requirement definition, anatomical modeling, verification and validation testing, preclinical protocol development, data analysis, risk management, FDA regulatory compliance, cross-functional collaboration
Preferred skills
Medical device experience, advanced degree in biomedical/mechanical/electrical/biological science or medicine
Technologies
FDA regulations, Quality Management Systems (QMS), Environmental Management Systems (EMS)
Responsibilities
Define user needs and clinical requirements for new product development; develop anatomical models and perform V&V testing; gather and translate input requirements into system specifications; simulate or test prototypes to validate intended use; develop preclinical evaluation protocols and reports; contribute to risk management files and Clinical Evaluation Reports; support Quality and Environmental Management Systems compliance
Seniority
Senior, hands-on IC