New York



Expert No. 3660

Profile

Broadly experienced medical device engineer with a PhD in Biomedical Engineering background and proven experience in teaching & mentoring both undergraduate and graduate students, cardiovascular signal analysis, medical device design, research and development, implementation, project direction and business development.

Strong base in current medical device research and development, diagnostics, and communications strategies with a track record of successful management and implementation of strategic initiatives of varying sizes and complexities.

Recent research & development experiences in:  Interventional Cardiovascular Devices, Cardiac Pacing devices; Cardiac Stents, Artificial Organ Design, Neuro-modulation; Biocompatibility Studies; FDA Device Controls & Regulatory Issues; CNS – Epilepsy; Neurology; Cardiology, Cardiac Echo Imaging; Nuclear Medicine, MRI and CT Imaging.

Objective

Seeking full time strategic and/or tactical opportunities to help develop or manage the development of medical devices and related projects with proven engineering and research & development expertise in the following areas:
       
•Medical Device Research & Development
•Clinical Device Trial Management
•New Business Development & Due Diligence
•Medical Device Safety / Compliance
•Competitive Medical Device Market Analysis
•Systems implementation
•Cardiovascular Biomaterials
•Tissue Regeneration
Summary of Skills and Areas of Expertise
 
•Cardiac Resynchronization Management Therapy Devices
•Artificial Organ Design (cardiology and neurology)
•Cardiac Echocardiography
•Cardiovascular Therapy Devices/Systems
•Neurological Therapy Devices/Systems
•Physiological Monitoring
•Clinical Medical Device Trials
•Cardiac Electrophysiology
•Heart Failure Studies
•FDA Device Design Controls
•Engineering Project Design and Management
•Patent Prosecution

Education

8/2008, GPA-3.60/4.00
Cleveland State University / Lerner Research Institute
(A collaborative doctoral program)           
Doctor of Engineering, Biomedical Engineering                
Emphasis in Cardiac Resynchronization Management Therapy Devices

7/2002, GPA, 3.3/4.0
University of Pittsburgh   
Master of Science, Bioengineering           
Emphasis in Artificial Organ Devices (cardio-pulmonary applications)

University of Virginia,
Master of Engineering, Biomedical Engineering    1/1981
Emphasis in Electrical engineering and Biomedical Signal Transducer Theory and Design

5/1977
Syracuse University,                       
Bachelor of Arts, Pre-medicine    

Experience

2010-Present
Medical Device Consultant at Laughlin Engineering Firm, LLC   

•Providing ethical and quality biomedical and forensic engineering services to clients
•Providing expertise in both preclinical &clinical medical device trials
•FDA medical device submission
•Product development testing

2009-Present
Adjunct Assistant Professor in Engineering Science
College of Staten Island                           

•Teaching both lecture and laboratory courses for the Engineering & Physics department including
•Co-collaborator & faculty consultant in the development of a Biomedical Engineering Lecture/Lab course

2005-2008
Pre-doctoral Fellow at the Lerner Research Institute           

•Cardiac resynchronization therapy devices (cardiac pacing systems)
•Co-coordinated preclinical device trials using the canine model to evaluate the effectiveness of a novel cardiac pacing paradigm
•Conducted conscious testing of animal subjects for cardiac pacing research studies
•Conducted cardiovascular signal monitoring sessions (over 200 physiological monitoring sessions)
•Participated and assisted in the surgical implantation of cardiac pacing devices (over 75 surgical implants procedures in the Cleveland Clinic’s Atrial Fibrillation Innovation Center)
•Actively involved in the design and analysis of cardiac echocardiography studies using the GE Vivid 7 system
•Coordinated monitoring/gathering of physiological data during surgical implantation of pacing devices with Cardiologists and Cardiac Echo Specialists
•Conducted bench studies in the research and development & wireless pressure sensors
•Provided consultation to surgeons, echo cardiologists, cardiac EP cardiologists/scientists with monitoring protocols

2000-2002
Graduate Biomedical Engineering Student
University of Pittsburgh                           

•Actively involved in the research & development of an Artificial Diaphragm Muscle System
•Served as a Teaching Assistant for the senior bioengineering design course in the University of Pittsburgh Bioengineering Department

Publications

Available Upon Request

Honors & Awards

•Cleveland Clinic's Innovation Award (Research in the use of Novel Cardiac Pacing Paradigms for Heart failure patients) 10/2008
•Cleveland Clinic's Innovation Award (Research in the use of Novel Cardiac Pacing paradigms for Heart Failure patients) 11/2007
•Elected in the Tau Beta Engineering Honorary Society, 12/1996
•Superior Achievement Award, United States Patent & Trademark Office, 2/1983

Professional Organizations

•The American Heart Association
•The Biomedical Engineering Society

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