Senior Engineer, R&D
Core
Design and develop heart valve systems (TAVR) using Finite Element Analysis (FEA), test method development, and simulation to address unmet clinical needs in structural heart disease.
Role type
Senior R&D Mechanical Engineer (Medical Devices)
Builds
Transcatheter Heart Valve (THV) frames, access and delivery systems, and virtual/bench models for clinical validation.
Domain
Medical Devices / Cardiovascular / Structural Heart Disease
Required skills
Finite Element Analysis (FEA), test method development, cardiovascular anatomy knowledge, mechanical engineering problem solving, statistical shape modeling, boundary condition definition, non-linear material modeling, technical documentation, regulatory compliance (FDA/QSR)
Preferred skills
ANSYS, ABAQUS, Materialise, Simpleware, MATLAB, Minitab, ISO/ASTM standards, ASME V&V 40, non-linear material experience, cardiovascular device experience, FDA submission experience
Technologies
ANSYS, ABAQUS, Materialise, Simpleware, MATLAB, Minitab
Responsibilities
Lead FEA model development for access and delivery systems; develop statistical shape models for patient anatomy; lead test method development for clinically accurate boundary conditions; collaborate with clinical teams on pre-clinical and clinical environments; interface with regulatory and quality personnel; solve mechanical engineering problems at component and system levels.
Seniority
Senior, hands-on IC