Technical project leader of product development design controls, from concept to product launch, for single use intravenous, full core biopsy, and foreign body manipulation & retrieval medical device product lines. Collaborated with marketing to establish competitive landscape improvements, interpret user needs to identify features that direct and define product design and project scopes. Cooperate with cross functional manufacturing, production, and quality groups; to evaluate design for manufacturability, risk analysis (DFMEA, PFMEA, & UFMEA), and design reviews. Design & development of medical devices, critical tooling / fixturing necessary for assembly, and manufacturing. Draft product drawings and specifications. Facilitate verification & validation testing, and author data driven testing protocols and reports used to establish substantial equivalence for FDA 510(k) submission.Delivered Results:Project leader accountable for product development activities on various foreign body retrieval systems including: Argon Retrieval Kit® and Halo Snare Line®Collaborated with cross-functional team to complete and release the BioPince Ultra® full core biopsy deviceDeveloped Nitinol heat forming fixtures for foreign body retrieval systemDesigned various plastic components for injection moldingExecuted verification and validation studies on injection molding components and tooling

Experience implementing new equipment with associated validations while improving manufacturing efficiencies and maintaining high levels of production in a high mix low volume environment.Delivered Results:Increased production of dilators, introducers, and catheters approximately 15% by design and implementation of more efficient fixturing, new RF tipping machines, and consolidating similar sizes while reducing scrap Reduced Extrusion change over and down time approximately 22% by designing a pneumatically fed hopper, quick change fixturing for regular and cross head dies, loading trays, and other critical components for extrusion machinesFormed written test procedures, and design verification studies for manufactured products; including tooling/fixturing, tipping machines, molding presses, and fully automated machines Created, updated and executed BOMs, Routers, Process Validations (IQ, OQ, PQ), Operating Procedures

Primary responsibilities were to assist manufacturing engineers by troubleshooting down equipment, developing solutions via modeling, and drafting prints to send out for fabrication.

Safely and efficiently installed, repaired, and upgraded electrical equipment in large scale Austin area hospitals.Diagnosed malfunctioning systems to identify hazards, defects, and the need for repairs.Strived to maximum productivity and minimize the disturbances of clients throughout business operations.

Served as team leader throughout various missions in Iraq and the Pacific Theater Directed guard team of over 150 MarinesBeta tested 4 variants of prototype squad automatic weapon systems