-Experience within an FDA controlled, Document controlled, cGMP environment with a well defined QMS (Quality Management System).-Design of Experiments and Statistical Analysis-Compilation of documentation, including Product Specifications, Drawings, Tooling, Work Instructions, Protocols, Design History Records, Reports, and Laboratory Notebook Records. -Design of components and tooling in SolidWorks for machining, injection molding, and general fabrication.-Sterilization Validation.-Biocompatibility testing, including but not limited to in vitro testing through radiolabelling (In111) of human platelets in whole blood.-Biodegradation evaluation -Finite element modeling (FEM).-Characterization of Young’s modulus, Poisson’s ratio, creep, and stress relaxation.-Fatigue characterization of polymeric and composite materials.-Polymer fabrication techniques, including compression molding, dip molding, and solvent casting. -Design and prototyping of minimally invasive, percutaneous, and stented polymeric trileaflet heart valves for in vitro and in vivo verification and validation.Specialties: -Design in SolidWorks (Up to 2010)-Finite Element Modelling-Statistical Methods-Verification and Validation as per FDA requirements-Testing methodologies according to FDA, ISO, or ASTM standards