Medical Devices Mechanical Engineer Expert Witness
Medical Devices Mechanical Engineer, Medical Device, Cardiac Surgery Medical Device Engineer, Cardiopulmonary Bypass Medical Device Engineer, Quality Systems Medical Device Engineer, Heart Lung Machine Mechanical Engineer, Dialysis Medical Device Engineer, Respiratory Care Medical Device Engineer, Blood Oxygenator Mechanical Engineer, Medical Devices Mechanical Engineer ECMO, Medical Device Litigation, Medical Device Regulatory Compliance, Cardiac Heart Machine Mechanical Engineer, Extracorporeal Medical Device Technology, Forensic Medical Device Engineering, Medical Instrumentation Engineer, Respirator Mechanical Engineer, Humidifier Mechanical Engineer, Pulmonary Function Analyzer Mechanical Engineer, Intensive Care Ventilator Mechanical Engineer, Cardiovascular Surgery Products Mechanical Engineer, Cardiovascular Surgery Product Quality Mechanical Engineering, Cardiovascular Surgery Medical Device Product Clinical Evaluation, Dialysis Medical Device Products, Extracorporeal Life Support Medical Device, Physiologic Pressure Monitoring Medical Device, Surgical Blood Salvage Medical Device, Material Toxicity Testing Medical Device, Microbiology Medical Device, Hemodialysis Medical Device Equipment, Hemodialysis Equipment Mechanical Engineer,
Expert Witness No.1341
Colorado
Education
1953-1955 Loveland High School, Loveland, Colorado
1955-1957 Canon City High School, Canon City, Colorado
Colorado State University, Fort Collins, Colorado, B.S. Degree, Mechanical Engineering
University of Houston, Houston, Texas, Part time Student, M.S. Degree, Mechanical Engineering
Thesis Title: Filtering Characteristics of a Long Steel Bar with Discontinuities in Cross Sectional Area
Thesis Advisor: Douglas Muster, Ph.D., Department Chairman, University of Houston, Houston, Texas
Ph.D. Degree, Mechanical Engineering
Dissertation - A large portion of course work and all research was done in the Physiology Department of Baylor College of Medicine, Houston, Texas.
Harvard Medical School at the Peter Bent Brigham Hospital
Post Doctoral Studies in Bioengineering, Pulmonary and Intensive Care Medicine
Advisor: Philip A. Drinker, Ph.D.
Academic Honors
Pi Tau Sigma , Mechanical Engineering Honorary, C.S.U.
Omicron Delta Kappa, Scholastic and Service Honorary, C.S.U.
Sigma Xi, Research Oriented Honorary, Univ. Houston
Fellowships and Teaching Experience
Texaco Fellow in Mechanical Engineering, Univ. Houston, 1966-1969
Student Asst., Baylor, 1967
Laboratory Assistant, Physiology Laboratory, Baylor, 1966-1969
Professional Affiliations
National Society of Professional Engineers (NSPE)
American Society of Mechanical Engineers (ASME)
New York Academy of Sciences (NYAS)
American Society for Quality (ASQ)
Regulatory Affairs Professional Society (RAPS)
National Academy of Forensic Engineers (NAFE), Senior Member and Board Certified Diplomate in Forensic Engineering by NAFE, a CESB Member Board
Registered Professional Engineer in Colorado- American Society of Extracorporeal Technology (AmSECT)
Past Affiliations
Association for the Advancement of Medical Instrumentation (AAMI)
Certified Clinical Engineer by AAMI
American Academy of Cardiovascular Perfusion (AACP)
AdvaMed (formerly Health Industry Manufacturer’s Association, HIMA)
Professional Experience
Texaco, Inc., Research and Technical Division, Bellaire, Texas
Position; Mechanical Engineer
Job Description; Mechanical design of miniature mechanisms, acoustic wave propagation, oil well drilling research, electromechanical and nuclear well logging research, hydraulic power design.
Texaco, Inc., On Educational Leave
Monaghan Company, Littleton, Colorado
Positions: Product Development Engineer; Manager, Product Development
Job Description: Design and development of products used in diagnosis and treatment of lung disease; respirators, humidifiers, pulmonary function analyzers, and intensive care ventilators.
Harvard Medical School (see above for details)
Monaghan Company (became Hospal Medical Corporation)
Positions: Staff Scientist: Product Manager
Job Description: Acted as consultant to engineering and marketing departments in several phases of product planning and development.
1983 COBE Laboratories, Inc. Lakewood, Colorado
Positions: Cardiovascular Division, Clinical Monitor; Manager, Clinical Affairs
Job Descriptions: Responsible for clinical evaluation of new cardiovascular surgery products. In charge of quality engineering and clinical evaluation for cardiovascular surgery products
1983-1986 COBE Laboratories, Inc., Lakewood, Colorado
Position: Renal Care Division, Manager, Advanced Projects
Job Description: Responsible for a group doing technological outreach for application in dialysis products.
COBE Laboratories, Inc., Lakewood, Colorado
Position: Director, Quality Assurance, Cardiovascular Division
Job Description: Responsible for all quality assurance and regulatory activities for one of two corporate divisions dealing with extracorporeal life support, physiologic pressure monitoring and surgical blood salvage. Included quality control, quality engineering, corporate biochemistry laboratories, product liability and regulatory activities. Also responsible for environmental health and safety issues for the corporation
COBE Cardiovascular, Inc., Arvada, Colorado (new corporation)
Position: Director of Quality and Regulatory Affairs
Job Description: Responsible for all quality and regulatory activities in the fields of extracorporeal life support, physiologic pressure monitoring, surgical blood salvage and related products. Responsibilities included domestic and international regulatory and standards compliance and submissions activities (FDA, ISO 9001 and CE Marking), quality assurance, quality engineering, clinical monitoring, material toxicity testing, microbiology, OSHA, EPA and product liability issues.
Gambro Renal Products, Inc., Lakewood, Colorado
Position: Director of Quality and Regulatory Compliance
Job Description: Responsible for quality and regulatory compliance for a manufacturer of hemodialysis equipment. Responsibilities included regulatory and standards compliance for FDA, ISO 9001 and CE Marking, quality engineering, receiving quality and complaint management.
2001- Present Retired from Gambro/ COBE and started quality/regulatory and expert witness consulting company.
Patents, Publications, Major, Minor Will Be Available Upon Request
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