Engineer R&D Disposables
Lake Zurich, Il, Us
• Headed Disposables Core Team Lead position in multiple business expansion NPD projects with responsibility in DHFdocumentation, design, interfacing with contract design firm, coordinating plant builds for FTC, FTX codes, concurrentengineering, and researching science behind current technology.• Functioned as Disposables Core Team Lead in DHF Remediation activity for legacy products; led to successful filling of FDA 510K.• Developed Product wide Disposables Definition Requirements for AUTO-C in DOORS software for revision and traceability maintenance.• Utilized SolidWorks to model parts, testing fixtures, edit component and assembly drawings, and evaluate components and assemblies for accuracy.• Lead and performed aging studies for plasma storage containers, while inspecting for material integrity and product reliability.• Lead and performed distribution studies for Plasma kits, which required modifications to the packing based upon initial results.• Garnered a strong understanding of VOC based upon customer interactions through direct support, NPD projects, and immersion programs; VOC consideration constantly applied to disposable design and change implementations.• Successfully led and resolved a CAPA issue pertaining to customer complaint of blood clots during apheresis.• Supported filter development with manufacturing plant utilizing RF welding technology.