Provided engineering skills and services in both product development and renewable energy roles. My career consist of over 25 years of product design and 13 years of renewable energy projects.Product Development:• Accomplished Director and Senior Engineering Manager with 20+ years of product development experience• Simultaneous inventor and/or developer of medical devices and regulated device software• Comprehensive Product Development Life Cycle background• Liaison and interface with FDA and other governing bodies for new technology approval Renewable Energy:• Energy production modeling • Large project ROI investment analysis • Complete solar PV design and construction managment• Licensed Professional Engineer and NCEES Record HolderKEY SKILLS AND COMPETENCIESEnergy modeling and project forecastingRenewable energy project development and design Engineering & Project Management expertise required to design and market medical devices in the regulated industry.Leading complex, product development initiatives to advance strategic product and corporate objectives.Managing hardware & software engineering resources composed of onsite resources, design consultants and diverse international teams to bring new devices to market.Ensuring and advancing product quality through CAPA processes and compliance to both federal regulations and international standards.Experienced in ISO 9001, ISO 13485, CFR 820, CIM (Computerized Integrated Manufacturing), SPC (Statistical Process Control), and TQCM (Total Quality Cost Management) working environments.
Listed skills include Solar Pv, Cfr 820, Engineering Management, Lean Manufacturing, and 30 others.