Medical Device Electrical Design Expert

Expertise

• Providing over thirty years in the medical device industry in areas of development engineering, product assurance, and clinical engineering.
• Medical device.
• Quality systems.
• Project leadership.
• Design quality assurance.
• Validation Testing.

Expert Witness Experience

• Patent Infringement litigations.
• Product liability litigations.
• On site regulatory inspections.

Experience

Undisclosed Company, Owner, 2002 - Present

Projects

• New design for stereo subwoofer with two patents issued.
• Cardiac simulator training tool.
• Contract circuit design.
• CADD-Computer Aided Design and Draft
• Embedded system design.
• Hardware design.
• Software design: C, assembly.
• PCB design and layout.

S. M. D., Systems Engineer, 2006 - Present

• Medical device development.
• Requirements management.
• Validation testing.
• Circuit design.

H/P, Co-Founder, 2007 - Present

• Start-up company developing audio technology consumer electronics.
• Hardware design.
• Software design.

A. G. T., LLC, Chief Engineer, 2005 - Present

• Initial stage start-up company founded to develop implantable medical device for cardiac arrhythmias and drug delivery systems.
• Hardware design.
• Software design.

St. Jude Medical Inc., Durango, CO, Sales Representative Principal, 2003 - 2006

• Manufacturer and distributor of Cardiac Rhythm Management medical devices (pacemakers and defibrillators).
• Captured 100% of market from competition.
• Sales representative for implantable cardiac pacemakers and defibrillators.
• Responsible for implant support, device monitoring and troubleshooting.
• Sales for bradycardia, tachycardia and biventricular rhythm management devices.

Equestron LLC, Park City, UT, Chief Engineer, 2003 - 2005

• Initial stage start-up company founded to develop devices for detecting and monitoring lameness in horses.
• Developed data collection equipment for studies.
• Hardware design.
• Software design.

LifeSentry, Inc., Houston, TX, Vice President-Engineering, 2002 - 2004

• Early stage, start-up company developing diagnostic devices for congestive heart failure, vulnerable plaque and other cardiovascular diseases.
• Assist development of product strategies.
• Prepare SBIR grant applications.

Quetzal Biomedical, Inc., Durango, CO, Director-Engineering, 2000 - 2002

• Company founded to develop implantable medical device to treat congestive heart failure.
• Designed prototype implantable devices and data acquisition systems.
• Designed and built research data acquisition equipment, based on National Instruments data collection hardware and LabView software with custom signal conditioning circuitry.
• Designed microprocessor-based test equipment controller.
• Developed software based heart/pacemaker simulator.
• Assisted in development of quality system and design control procedures.
• Participated in in-vivo studies.
• Helped develop product strategies.
• Head of Engineering, reporting directly to the CEO.

Logitronics, Inc., Lake Jackson, TX, President, 1990 - 2000

• This company identified market need for cardiac pacemaker test equipment.
• Develop microprocessor based heart simulator.
• Design assembly language software, visual basic software, and analog and digital hardware.
• Perform all aspects of project, including PC board layout, purchasing, business administration and approval applications.
• Arrange contract production.

Guidant Intermedics, Inc., Angleton, TX, 1981 - 1999

Senior Manager, 1998 - 1999

• Provided performance analysis for this International manufacturer and distributor of implantable cardiac rhythm management devices.
• Decommissioned and transferred department to Guidant.
• Manage department responsible for analysis of returned products, field problems, select production failures and all corrective actions.
• Manage staff of professional and technicians, and a $ 1.5 million budget.
• Represent company during regulatory inspections and legal situations regarding product performance.

Corrective Action Board Coordinator, 1996 - 1998

• Improved efficiency of Corrective Action System, decreasing typical resolution time by two weeks with significant reduction of potential liability.
• Increased scope of Corrective Action System to more aggressively pursue problems with all product lines and at more phases of the product life cycle.
• Increased influence of Corrective Action System by participating in product development activities, improving product quality by introducing product performance data into new designs.
• Led product performance analysis activities for several product recalls, including investigation, analysis and corrective action implementation, and participated in regulatory agency review.
• Administer Corrective Action System, including all investigations, evaluations and corrective action recommendations regarding product performance.
• Work with interested parties (sales representatives, patients, physicians, regulatory agencies and legal) regarding product performance.
• Represent Product Analysis on Medical Device Reporting Committee.

Principal Design Engineer, 1990 - 1996

• Met with FDA to discuss regulatory strategy and submission issues for new product.
• Assisted in implementation of aggressive submission strategy that reduced approval time by six months, resulting in increased sales of $12 million.
• Designed assembly language software routines, and analog and digital circuits.
• Lead project for implantable microprocessor-based cardiac pacemakers from early concept to market release.
• Represent Engineering on Change Control Board.

Manager, Customer Service, 1988 - 1990

• Increased competence of department from a non-technical group to one providing technical and sales support, including attending implants and presenting material at training sessions.
• Increased efficiency resulting in savings of $67.5K and a more focused time management system overall.
• Manage department responsible for providing technical field support, communication of analysis results for returned products, and clinical support to the Reliability Analysis Laboratory.
• Manage staff of three professional and three clerical.
• Represent company during regulatory inspections and legal situations regarding product performance.
• Chair Medical Device Reporting committee.

Clinical Program Manager, 1984 - 1988

• Management of clinical evaluation of new products.
• Provide technical assistance to the field (sales representatives, physicians and patients).
• Provide field support, including attending implants and presenting material at training programs.
• Provide clinical support to design engineering.

Reliability Assurance Engineer, 1983 - 1984

• Performed reliability testing on electronic components.

Reliability Analysis Engineer, 1981 - 1983

• Performed failure analysis on implantable pacemakers to the sub I.C. level.

Honors & Publications

Credentials

Post-Graduate Activities

• General Management, Unix, Networks, Brazosport College
• Computer Science MIT- Massachusetts Institute of Technology

License

• Professional Engineer, Texas

Academic and Professional Affiliations

• Member, IEEE
• President RPI ambulance, RPI, Troy, NY

Publications and Patents

• Author-Co-Author of numerous publications in peer reviewed Medical Journals
• Inventor-Co-Inventor of numerous patents

Education

• B.S. Biomedical Engineering, Rensselaer Polytechnic Institute, Troy, NY
• B.S. Electrical Engineering, (Minor) Rensselaer Polytechnic Institute, Troy, NY