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Medical Device Electrical Design Expert

Technical Consultant #2416


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
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