
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.
icumed.com
olympus.com
realstaffing.com
glginsights.com
phillipsmedisize.com
ergotron.com
exxonmobil.com
Greater Minneapolis-St. Paul Area
Founder | Product Development Engineering Manager | Engineer
Leaders in Product Development Engineering Management | Greater Minneapolis-St Paul Area
Jan 2012 - Present
Consultant in Medical Product Development
GLG (Gerson Lehrman Group)
• www.linkedin.com/company/glg
Nov 2007 - Present
Regulatory Affairs / Quality Assurance Consultant
NACS, Inc.
• www.linkedin.com/company/nacs-inc.
Feb 2020 - Mar 2020
Ham Lake, MN
Senior Design Assurance Engineering Consultant
Olympus Corporation of the Americas
• www.linkedin.com/company/olympus
Mar 2017 - Dec 2017
Senior Engineering Consultant | Engineer
Phillips-Medisize
• www.linkedin.com/company/phillips-medisize
Jan 2015 - Dec 2016
Greater Minneapolis-St. Paul Area
Product Design Manager
Katecho Inc.
Jan 2012 - Dec 2013
Des Moines, Iowa Area
Manager
Remington Four International
Jan 2007 - Dec 2012
Mechanical Engineering Manager
LaserMaster
Jan 1995 - Dec 1997
Structural Mechanics Manager | Structural Mechanics Supervisor | Senior Staff Engr. | Staff Engr.
Honeywell / Alliant Techsystems - ATK
Jan 1987 - Dec 1995
Greater Minneapolis-St. Paul Area