medical device consulting . engineering . project management |
Selected Project Work
Start up and continuing management of full-service engineering services, automation design and fabrication entity (Abilitek, Inc) Development and implementation of proprietary process and equipment designs from concept to completion, including installation and validation (Abilitek, Inc) On-site management of new device start-up development and manufacturing, including vendor process qualification, process validation and product v&v testing (Abilitek, Inc) Senior partner in start up and management of medical device consultancy (Cathion/Vascon LLC) Specification, design and layout of overseas extrusion, braiding, catheter manufacturing, balloon and stent manufacturing, and injection molding and sterilization facilities (Cathion/Vascon LLC) Project planning, management, budgeting and manufacturing line layouts for implementation of $5M/15,000 square foot hydrophilic guidewire manufacturing facility encompassing two floors - installed an automatic hydrophilic coating and curing system around considerable facility and timeline restrictions (Boston Scientific MTC) Construction completion and validation of a new Phase I Class 100k cleanroom manufacturing facility - project leader for Phase II facility build out (Cordis CNV) Installation and production scale up of neuroradiology infusion catheter and guidewire manufacturing lines into the new facility (Cordis CNV) Developed manufacturing line layouts for implementation of continuous flow manufacturing and conversion to Class 100K Cleanroom (Cordis Peripheral Stent Mfg)
Selected Process Work
On-site CAPA remediation of DHR systems and shop floor paperwork practices (Abilitek, Inc) On-site CAPA remediation of process IQ/OQ/PQ, test method validations, testing equipment, and documentation (Abilitek, Inc) On-site rebuild of design control and quality systems for ISO certification (Abilitek, Inc) Detailed CAPA product failure analysis, testing, and product specification re-development, including development of in-vitro biomechanical modeling (Abilitek, Inc) Process development equipment design/procurement and installation/qualification of catheter body manufacturing, centerless grinding, tipping, adhesive bonding, pad printing, tip drilling and forming, and final packaging operations (Cathion/Vascon LLC) Development, design and deployment of processes and equipment for coil winding, plasma-arc welding, soldering, PTFE sleeving, fusing, cleaning, coil trimming and component assembly (Cordis CNV) Complete process engineering and validation responsibility for centerless grinding, angle forming, and automated hydrophilic coating and curing (Boston Scientific MTC) Developed in-house microcatheter product technology, including the design development of a low-cost precision coil winder for winding catheter bodies (Cathion/Vascon LLC) Developed detailed specifications and design for laser welding station to high-speed machine vision controlled system and installed to feasibility; this system took an operator dependent process and made it fully automatic – from (1) weld every 6 seconds to (1) weld per second (Cordis Peripheral Stent Mfg) Developed high-speed coil winder - supervised in-house design and outside automation contractor on fabrication and debug; designed and fabricated the "2nd generation" winder; currently in daily operation in two different facilities winding embolic, catheter and guidewire coils (Cordis CV/CNV/Abilitek, Inc) Key member of “Lean Manufacturing” task force that developed and implemented flow manufacturing. Initiated line layouts and facility plans to work around production schedule that allowed implementation despite concurrent production requirements (Boston Scientific MTC) Mechanical design, fabrication and debug of "pick and place" robotic test system for SMT ceramic chip capacitors (Alpha Automation) Mechanical design, fabrication and debug of high temperature and high-temperature mass "burn-in" and thermal fatigue semiconductor test systems (Alpha Automation) Mechanical design, fabrication of low-cost fiberoptic light illuminated visual inspection tool for particle detection (Class 10 Cleanroom use) for monolithic minicomputer circuits (Alpha Automation)
Selected Process Experience
Automated Cleaning Systems Automated Testing Systems Automatic and Manual Adhesive Bonding Centerless Grinding Component Micro-Assembly Fixturing CNC and Manual Machining Operations Custom Cutting and Machining Operations Fine Wire Braiding – Rotary and Maypole Hydrophilic and Hydrophobic Coatings and Equipment Injection and Insert Molding Operations Investment Casting Operations Laser, TIG, Plasma-Arc and Resistance Welding Machine Vision Metal Bonding and Swaging Metal Polishing and Finishing Micro-Coil Winding Microelectronics Assembly and Testing Micro-Extrusion Operations (Air Mandrel and Corewire/Topcoat) Micro-Soldering and Brazing Pad Printing/Product Labeling Polymer Fusing and Forming Product Packaging Thermal Sleeving and Jacketing Tumbling and Vibratory Finishing Wire Forming, Joining and Straightening
Selected Clients
Boston Scientific Miami Technology Center
Boston Scientific SciMed
Cordis Corporation - Johnson & Johnson Neurovascular (now Codman) and Cardiovascular (now Cardinal Health)
Cordis Europe
Edwards Lifesciences
HeartWare
IMI Medical
Kenneth Crosby
Noven Pharmaceuticals
SafeStitch Medical (now TransEnterix)
Scion Cardiovascular
Terumo Cardiovascular Systems
Terumo Heart (now St. Jude Medical)