Engineer | Manager | Consultant | Medical & Industrial Product Development | Design Validation, Verification | Test Method Development | Protocol Development | FDA, ISO ◆jhbode1@msn.com ◆612-554-0321 DELIVERING PROJECT EXCELLENCE, DRIVING RESPONSIVE PRODUCT DEVELOPMENT SUPPORT Technologist with a track record of meeting and exceeding expectations in new product development including R&D, rapid prototyping, testing and transition to manufacturing in compliance with regulatory requirements. Internationally registered professional engineer with several granted US patents and two medical sterility assurance ASTM Testing Standards. EXPERIENCED TECHNOLOGICAL INNOVATOR • Test Method Protocol Development, Validation, Verification, Qualification, IQ, OQ & PQ. • Design, manufacturing & sterility assurance of Class I, II, & III Medical Devices. • Developing testing devices, processes and standards. PROFICIENT ENGINEERING CONSULTANT AND SUBJECT MATTER EXPERT • Adherence to ISO, FDA, RoHS, CE, UL, CSA, ASME, ASTM, ANSI, etc. • Gage R&R, DOE, FMEA, Fishbone root cause analyses, design verifications, bio-compatibility studies. • Test method validation protocol development, etc. TRUSTED MANAGER • Time and cost management, task prioritization to meet or beat deadlines. • Managing & adhering to internal and external, contractual, documentations • Developing workload forecasts. • Analyzing information & data for technical, business and formal project management decisions, • Leading product developments including design reviews where nimble responses are crucial in meeting strict product specifications, timelines and budgetary constraints. • Team building, proficient in staff development, mentoring, rewarding, & refocusing. I have a knack for meeting with customers, listening to their needs and providing them with timely and cost effective solutions. Similar to software development, personally and professionally I'm in a permanent beta phase, constantly iterating and improving.