Carol Stream, Illinois, United States
Responsible for developing medical device mechanical hardware, electrical hardware, firmware, and software using external Industrial Design Firms and design consultants, as well as internal resources, and budgets. . Knowledgeable in: 21 CFR 820.30 Design Control Projects (DCP), Design History File (DHF), FDA QSRs, ISO 13485, Document Control, Change Management, EtQ, ISO 14971 Risk Management, IEC 60601-1, FDA 510(k) submittals, Design Review, Design Verification, Design Validation, Design Transfer, user focus groups, and user interface design. Cutting edge, hands-on, creative technology and engineering manager, valued for designing and patenting commercially viable products and services that build the next generation of profits. Recognized for monitoring and guiding complex products from inception, through development, regulatory compliance and intellectual property processes, marketing, and implementation. Communicates effectively at all levels of the organization and with partners, bankers and clients.
Providing consulting services on medical device design, intellectual property, process control, and business processes.
INNOVATIVE NEUROTRONICS, INC. (division of HANGER ORTHOPEDIC), Wheaton, IL / Austin, TX Develops and commercializes emerging technologies in collaboration with independent researchers and suppliers worldwide. IN, Inc. specializes in the development of medical devices for rehabilitation, with a concentrated focus on Prosthetic and Orthotic technologies. Director of Product Design & Engineering Managed external Industrial Design Firms and design consultants, as well as internal resources, and budgets. Responsible for developing the mechanical hardware, electrical hardware, firmware, and software of the company’s flagship wearable medical device, WalkAide. Knowledgeable in: Design Control Projects (DCP), Design History File (DHF), FDA QSRs, ISO 13485, Document Control, Change Management, EtQ, ISO 14971 Risk Management, IEC 60601-1, Design Review, Design Verification, Design Validation, Design Transfer, user focus groups, and user interface design. Developed the WalkAide: • WalkAide system: Functional Electrical Stimulator (FES) for foot drop. Patient stimulation triggered by a MEMS accelerometer. Bluetooth telemetry and custom software utilized in the gait lab for patient configuration. The system launched in the U.S., Japan, and internationally. • Bi-Flex Cuff: New body-worn component of the WalkAide system. Patent issued 2014. Additional medical devices developed: • V-HOLD: Elevated vacuum attachment for prosthetic limbs with Bluetooth telemetry. • iO Compliance Monitor: Internet of Things embedded patient wear compliance monitor for Scoliosis brace and Neuropathic Walker.
Independent Medical Device Consultant. Clients: • Abbot Diagnostic Division Medical device QA, implemented CAPA projects using Six Sigma DMAIC methodology. • Hanger Orthopedic Group Medical device R&D, feasibility analysis on the WalkAide system. The project became a separate company, Innovative Neurotronics, Inc.. • Smart Media of Delaware Consumer product R&D, continued development on the SnapShopper B2C media system, tablet computer on a grocery shopping cart.
SNAPSHOPPER INC., Lake Forest, IL / Washington, DC Grocery store B2C Media company with a color touch screen tablet computer and self-checkout system for grocery stores, including a barcode scanner, credit card reader and wireless LAN on a shopping cart. Vice President of Product Development (CTO) Outsourced an international group of consultants and companies to build a “browser on a shopping cart.” Oversaw the total product generation process. Managed an external industrial design firm, software development team and external hardware vendor, FUJITSU, Atsugi Japan. • Developed a self-checkout system for grocery stores, including a barcode scanner and credit card reader, a consumer marketing and device charging rack, POS emulation and connection software, 16 plastic parts and molds, web administrative tool, consumer interface, and custom firmware. • Created display device, wireless network and server software; adapted an existing color touch screen device. XML, HTML, Windows CE, MS SQL, MS IIS, COM & ASP utilized. • Participated in raising $3 million in capital funding.
SABRATEK CORPORATION, (purchased by BAXTER HEALTHCARE IN 2000), Skokie, IL $67 million medical device manufacturer and designer of stationary and ambulatory intravenous infusion pumps, proprietary disposable devices, telemetry and software for the alternate-site healthcare market. Vice President of Research and Development Vice President of Engineering Vice President of Advanced Technology Development Directed R&D, with 14 engineers and external design consultants. Supervised product generation (mechanical design, embedded electrical hardware, embedded firmware, software and V&V). Knowledgeable in: Pro/Engineer and SolidWorks 3D solids modeling and mechanical design software, FEA, and photo-initiated adhesives. Served on the senior management team during the IPO. • Generated 20% of revenue from the redesign of the main pump product, model 3030. • Developed an ambulatory IV infusion pump, model 6060, which earned $53 million (80%) of Sabratek’s revenue. • Developed a stationary IV infusion pump with touch screen, model 4040. • Developed an MS Windows and 3Com Palm PDA software product, MediVIEW, for remotely monitoring and controlling medical devices; received two patents for the MediVIEW product. • Developed an automated testing and preventative maintenance system for infusion pumps, PumpMaster, offering Sabratek a unique position in the market place. • Served on the corporate team for ISO 9000 certification.