Jeremy Scholze

Research and Development Engineer @Edwards Lifesciences

Irvine, CA, US

Next Generation Heart Implant Development- Conceptualized and prototyped new implant designs using SolidWorks and evaluated functionality for multiple endpoints - exploring novel implant technologies, treating different disease states, improving patient outcomes- Owned the manufacturing process to ensure proper machining, handling, and shaping of the implant using Solidworks modeling skills and knowledge of nitinol alloy processingQuantitative hemodynamic evaluation of implant effectiveness- Developed and managed a data acquisition system for in-vivo cardiovascular study using MATLAB to - build a repository for an internal strategic research initiative- Led R&D analysis of in-vivo hemodynamic pressure waveforms using MATLAB to bolster functional understanding of our product and guide decision making in active clinical trialsNew Supplier and New Product Coordination- Managed qualification of new supplier during development of a next-generation device to reduce supplier and shipment costs by 40% while gaining experience with spend management software, purchase orders, process sheets- Coordinate and manage weekly meetings to drive efficient implementation of project deliverables and meet key project milestones bringing next-generation products to market under an accelerated timeline- Using Solidworks, developed new injection molded parts designed to improve ease of assembly, eliminate need for adhesives on the manufacturing line, and comply with a new visual design languageFDA Compliance and Clinical Trial Activities- Orchestrated FDA-requested biocompatibility testing of a next-generation Early Human Use device for clinical trial expansion- Authored responses to FDA requests resulting in approval for trial expansion and providing an avenue for eventual commercialization- Worked with cross-functional parties to optimize workflow and navigate the sterile processing of 800+ implants and 10+ implant delivery systems

University of Pittsburgh

Bachelor's degree, Mechanical Engineering

Penn State University

Mechanical Engineering