Electronic circuit design, PCB layout; software, firmware, database development; 3D mechanical design.
Understanding FDA design controls and ISO requirements.
Managing products in a marketing capacity; accomplished project manager.
Resolving complex technology decisions; understand large technology purchases.
Writing, music, and photography.
Fine-art photographs have been shown in the regional area. Drummer and a singer; have performed publicly.
I am an experienced product development engineer (BSEE) and an FDA and ISO Quality Management System quality expert with decades of experience in the medical device industry, with a start in data communications design. I provide technical and business consulting to engineering and quality managers. I have experience in organizations of all sizes, in both the product and service industries. I have successfully run several small businesses and assisted in developing a product through to market launch.
I provide design work and quality consulting, including lean, FDA QSR compliance, design assurance, design controls, risk analysis, process validation, problem investigation, and corrective actions.
I know what constitutes “Done”, understanding every technical and creative task.
My leadership focus is strong yet personable. I have excellent team-building and conflict-management skills and know-how to develop technical staff.
For continuous improvement, I have multiple Six Sigma Green Belts for DMAIC/Lean and DFSS, and I am a certified Six Sigma Black Belt (CSSBB).
My creative side includes writing, music, and photography. I have shown my fine-art photographs at regional area events. I am a drummer and a singer and have performed publicly in local bands.
I have the practical skills and capabilities to help your organization immediately.