Medical Devices, Mechanical Engineer Expert Witness

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:

1. National Society of Professional Engineers (NSPE)
2. American Society of Mechanical Engineers (ASME)
3. New York Academy of Sciences (NYAS)
4. American Society for Quality (ASQ)
5. Regulatory Affairs Professional Society (RAPS)
6. National Academy of Forensic Engineers (NAFE)
7. Senior Member and Board Certified Diplomate in Forensic Engineering by NAFE, a CESB Member Board
8. 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.

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

Medical Devices expert witness, Cardiac Surgery expert witness, Cardiopulmonary Bypass expert witness, Regulations expert witness, Quality Systems expert witness, Heart Lung Machine expert witness, Dialysis expert witness, Respiratory Care expert witness, Blood Oxygenator expert witness, ECMO expert witness, Medical device expert witness, litigation expert witness, quality systems expert witness, regulatory compliance expert witness