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


IMI Medical

Kenneth Crosby

Noven Pharmaceuticals

SafeStitch Medical (now TransEnterix)

Scion Cardiovascular

Terumo Cardiovascular Systems

Terumo Heart (now St. Jude Medical)