Engineering and Management consulting for the Medical Device Manufacturing industry. Project management of multiple site manufacturing and assembly operations.Develop and implement internal procedures for clients governing Quality Systems, Design Control, Process and Software Validation, Documentation Systems in accordance with ISO 13485 and 21 CFR 820.Validation of product, process and test methods.CAPA Investigation and in-depth failure analysis of polymeric, mechanical and electrical Medical Devices.New manufacturing facility design and construction, facility renovation and relocation. Cleanroom design, construction, commissioning and validation to ISO 14644, including environmental control and monitoring systems, and microbiological monitoring.Extensive experience in process development, design and fabrication of custom tooling, controls and equipment including injection molded components, Diagnostic and Guide catheters and Neuro-interventional microcatheters, guidewires and micro-guidewires, stents, embolic coils and delivery devices, LVAD devices, and shape-memory devices.3D Parametric Design in SolidWorks.www.abilitek.com

Senior Partner in six-person consulting operation to design, develop and transfer a state of the art Medical Device manufacturing operation to Shenzhen, ChinaHelped develop in-house Quality System and documentation to achieve full ISO/CE approval for US design and development operations along with QA/RAWorked directly with building architects in Hong Kong to develop building layouts, product flow, equipment requirements and manufacturing line layouts, including specification and design of cleanroom spaces

All project planning, budgeting and manufacturing line layouts for implementation of $5M/15,000 square foot hydrophilic guidewire manufacturing facility encompassing two floorsSupervised a large cross-functional project team including Automation Engineering, Coatings Engineering, Manufacturing and Quality; this project involved major facility re-construction and upgrades, including structural, power infrastructure, and HVAC systemsDelivered on-budget despite numerous marketing and product development delays to project

Interventional Cardiovascular, Neurovascular and Peripheral products including guidewires, stents, catheters, microcatheters, embolic devices and delivery systems and accessoriesAll aspects of Engineering, Management, Facilities and MaintenanceTwo successful new guidewire product line introductions under accelerated deadlinesInstallation and production scale up of neuroradiology infusion catheter and guidewire manufacturing lines into the new facility

Project management and shop supervision - all aspects including costing, purchasing, scheduling and documentationMechanical engineering and design, printed circuit board layout from schematics utilizing AutoCAD (releases 8 through 10)