Jacqueline Macias Email and Phone Number

• Lead R&D Engineer for an embolic protection system project.o Successfully led the design and development of an embolic protection device, Rapid Exchange delivery catheter, and Rapid Exchange Retrieval catheter from concept to regulatory submission.o Designed over the wire peel away delivery catheter and Rapid Exchange Retrieval catheter o Performed process DOE to optimize polyimide necking, Nylon and Pebax fusing parameters as well as to increase catheter transitional joints tensile strength. Ran statistical analysis of results, analyzed CpK and Ppk values to establish process specifications prior to manufacturing transfero Designed and built EPD and catheter prototypes using braiders, coil winders, catheter laminating machines, hot boxes for polymer fusing, electropolishing equipment, laser welders and hydrophilic coating machines.o Designed and developed assembly, test, and QC inspection fixtures. o Developed and documented test methods and manufacturing processes.o Scheduled, coordinated and managed product builds. o Modeled components and assemblies in CAD and created detailed drawings. o Wrote design verification and validation test protocols, tested prototypes, statistically analyzed the data and prepared reports. o Wrote design specifications, risk analysis and other documentation for the product development process and regulatory submission.• Lead R&D Engineer for a left atrial appendage (LAA) all polymer detachable coil for permanent closure of LAA o Led the conceptualization and development of distal protection integrated over the wire delivery catheter for deployment of coils to target location.o Designed and built pulsatile flow models as well as developed new test methods and procedures for pre-clinical evaluation of device performance. o Designed and built prototypes using CoCr, SS and NiTi. o Conceptualized and lead distal protection integrated PTFE lined over the wire delivery catheter and distal plug project (Feasibility)

R&D Engineer II• Lead R&D Engineer on (IntuiTrak) Abdominal Aortic Aneurysm (AAA) implanted self-expanding bifurcated CoCr alloy stent cage/ePTFE graft line extensions and aortic extension (Powerfit) project.o Design, built and tested prototypes developing test methods and implementing manufacturing processes. o Granted patent 08808350 for aortic extension implant design. o Project resulted in 30% revenue growth in the 3rd quarter 2010 and 41% revenue growth in the 4th quarter of 2010.o Proctored first OUS LMR cases in Sao Paulo, Brazil. • Process Engineer for Next generation (Powerlink) AAA Delivery System projecto Assisted in transfer of subassemblies and products from R&D to pilot manufacturing o Performed equipment IQ/OQ and ran DOE to define and optimize process parameterso Collaborated on pFMEA and cFMEA o Designed tooling and fixturing to facilitate manufacturability of subassemblies • R&D Engineer for Next generation (Powerlink) AAA Delivery System project. o Led the design and execution of .014” compatible SS/NiTi (SurePass) guidewire to maintain contralateral accesso Led the design and execution of perforated PTFE capsule for constrained controlled implant deployment o Drafted dFMEA o Prototyped and optimized delivery catheter hub to catheter shaft bonding o Prototyped coiled and braided (SS, NiTI) over the wire delivery catheters with hydrophilic coating, PTFE liner and Kevlar compositionso Worked with hydrophilic coating vendor to optimize catheter hydrophilic coating dripping process. Wrote and coordinated particulate testing build and report execution.o Developed test methods and wrote design verification and validation protocols for regulatory submissions.o Developed tooling design and assisted in transfer of newly developed products from R&D to pilot manufacturing. • Performed customer evaluation reports performed failure mode analysis for returned goods and generated report summary