30 years experience with design and manufacturing of class I, II, and III medical devices. 15 years of experience in Engineering Management developing electronic and mechanical products under ISO and FDA quality systems. 

Not your average manager, I prefer active involvement in the work, from building prototypes and troubleshooting to writing procedures. And yes, I have strong planning, organizational and leadership skills. I can supervise engineers and technicians, manage contractors as well as negotiate and manage contracts. I have experience with Asian and European suppliers and contractors. 

I'm familiar with testing and listing through Nationally Recognized Testing Laboratories (NRTL's). Experience with EMC compliance activities, IEC Standards, UL Standards, CSA Standards, CE marking, as well as RoHS and WEEE requirements.

Embedded processor circuits, digital logic, analog IC's and discrete components, power supply circuits, embedded design, and user interface design. Diverse EMC experience, ranging from switch-mode power supplies to 50-watt RF amplifiers. Familiar with power line transients, RF susceptibility, radiated and conducted noise, and ESD immunity. Broad experience with PCB design and prototyping.

Experience defining system architectures, communication protocols, selection of critical components, major supplier selection, and working with industrial designers and marketing. Familiar with typical manufacturing processes such as injection molding, vacuum forming, rotational molding, laser cutting, sheet metal fabrication, powder coating, surface mount assembly and others. Have led and participated in compliance reviews at all stages of product development. Knowledgeable in FDA design controls, ISO, IEC, UL and CSA Standards, CE marking, RoHS and WEEE requirements.

Education

Project Management Certificate, University of Alabama

Engineering Management Certificate, University of Alabama

Georgia Institute of Technology School of Electrical Engineering