Kerwyn Schimke

Senior Mechanical Engineer with extensive experience in development and design of implantable medical devices and consumer electronics. Accomplished in component design, system testing, and qualification of new products as well as close collaboration with production. Strong analytical and adaptive skills. Lead Development Engineer for long-term implantable devices. Managed component design, product qualification, and project completion through transition into production. Mentored new engineers, technicians and co-ops to help increase both their knowledge and effectiveness at company. Representative Projects: · Design and test of implantable cardiac lead projects. · Component and top level assembly design: - Prototyping components from concept to first article inspection - Documentation of product specification and test flow - Writing test protocols, test reports, and manufacturing instructions - Coordinating project workflow with manufacturing (DFM), regulatory groups - Final product qualification and FDA submission · Test Experience: High Speed Flex Testing, ISO Brady and Tachy Cardiac Pacing Lead Specification, CENELEC, In vivo and In vitro Testing. · Projects: - Improved material requirements and specifications resulting in 60% increase in material acceptance rates. - Developed crimping techniques for first SJM lead to use cable technology. - Senior development engineer for first SJM Over-the-Wire (OTW) Left Heart Lead. - Senior development and product engineer for first SJM endocardial lead.