Venkata Katragadda

•Over 24 years of experience in medical device development from early stage concept to commercialization in FDA regulated 510k and PMA environments. •Developed durable and disposable medical devices. Managed multiple projects in project manager role. •Assessed product concepts and identified technical risks including metrics such ROI and IRR. •Well versed in design control, design verification, design validation, design transfer, and risk management integration throughout product life cycle. •Experience with shelf life studies and sterilization methods. •Developed Design History Files (DHF) with user needs, design inputs, design outputs, evidence of verification and validation, design freeze, and design transfer. •Proficient in root cause analysis and CAPA execution. •Experience in working with KOL’s, gathering voice of customer and user needs. •Experience with detail drawings, tolerance analysis, and tools such as SolidWorks and Pro/E. •Formal training in Project Management, Statistics, and Design of Experiments. •Mentored junior engineers. •Two (2) time winner of Respironics key contributor award in product category. •Recipient of 3 patents, and inventor on other patent applications. Specialties: Product Development, Sustaining and Product Engineering, Risk Management, FMEA, Project Management, Design Transfer, Design Control, 510k testing, Product Safety Testing, Design Verification and Validation