Julius Okopi

Background

About Julius Okopi

An industry leader in Software Design Quality Engineering, helping medical device companies to create high quality embedded medical device software that are reliable, safe for patients and meeting all applicable regulatory compliance requirements. Expert in applying risk-based approach to product software development and validation to achieve good Return-On-Investment (ROI) in the process for the organization. • 25 plus years industry experience (Telecom, Semiconductors, & Medical Devices) • Leadership and mentoring skills (upstream and downstream) • Regulations: Expert level knowledge in regulations including: 21 CFR 820.30 21 CFR Part 11, Annex 11, ISO 13485:2016, IEC 60601, AAMI – TIR 36, TIR-45, GAMP, 21CFR 820.30, ISO 14971:2012, SDLC Models – Agile, Evolutionary, Spiral, etc, SDLC Models – Agile – scrum, Water Fall, Spiral, V-Model). • Risk Management tools: dFMEA, uFMEA, FTA, etc. • Tools: SAP, MasterControl, MQ1, Agile, JD Edwards, TFS, SVN, VISIO, GPIB, National Instrument tools Software Development: OO, C++, Python, JAVA MEDICAL DEVICE KNOWLEDGE: Ventilators, Infusion Pump, Urine Analysis Products, Infusion Pumps, Breast Cancer Detection Imaging Systems, Surgical Imaging Systems, Impedance Cardiographs, Remote Patient Monitoring Systems, and Advance Sterilization Products.