medical device industry
A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for ...
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medical device industry Employees
Medical Device Industry May 2014 - Present
Self-employed 2002 - Present
Irreconcilable Differences: MFA 2014 Graduation Exhibition February 2014 - April 2014
Skills
Visual Arts, Fine Art, Galleries, Drawing, Contemporary Art, Mixed Media, Sculpture, Art, Social Media, Art Education, Painting, Curating, Art History, Photography, Printmaking, Public Speaking, Watercolor, Adobe Creative Suite, Woodworking, Wood Shop, Ceramic Sculpture, Bronze Sculpture, Bronze Casting, Interior Renovations, Interior Design, Film, Masonry, Steel Design, Resource Management, Prop Making, Leatherwork, Costume Design, Costume Construction, Refurbishments, Sewing
Education
The University of Texas at El Paso
Bachelor's Degree, Sculpture and Ceramics
University of South Florida
Master's Degree, Fine and Studio Arts, Gender Studies
Radlink January 2015 - Present
Medical Device Industry October 2009 - 2014
Astra Tech (division of AstraZeneca) November 2000 - April 2005
Baxter Healthcare June 1997 - January 2000
St. Jude Medical August 1996 - May 1997
Skills
Cross-functional Team..., Product Marketing, Competitive Analysis, Medical Devices, Product Development, Marketing Strategy, Competitive Intelligence, Product Management, Marketing, Strategic Planning, Market Research, Product Launch, Market Planning, Market Development, Healthcare
Education
Duke University - The Fuqua School of Business
M.B.A
University of Colorado at Boulder
B.S
Medical Device Industry June 2010 - Present
DePuy Mitek, Inc October 1997 - June 2010
DePuy Mitek January 2008 - April 2010
DePuy Mitek January 2007 - December 2007
DePuy Mitek January 2006 - December 2006
DePuy Mitek January 2003 - December 2005
DePuy Mitek January 2002 - December 2002
DePuy Mitek January 2001 - December 2001
New Jersey October 1997 - December 2000
DePuy Mitek October 1997 - February 2000
Skills
Sales Management, Marketing Strategy, Online Marketing, Market Research, Product Development, Strategic Planning, Marketing Communications, Advertising, Product Management, Strategy, New Business Development, Product Launch, Product Marketing, Healthcare, Business Strategy, Business Development, Cross-functional Team..., Direct Sales
Education
Northeastern University High Tech M.B.A. 2006 — 2008
M.B.A., Business
Providence College 1991 — 1995
B.A. Degree, Business
Medical Device Industry January 2004 - Present
Shreveport Breast Center July 2001 - Present
Michael A Schwalke, MD, APMC October 1995 - May 2001
LSU in Shreveport July 1991 - October 1995
Skills
Cancer, Clinical Research, Healthcare, Oncology, Surgery, Medical Devices, Hospitals, Clinical Trials, Lifesciences, Medical Education, Medicine, Healthcare Management, Medical Imaging, Ultrasound, Surgeons, Clinical Development, Radiology, Physicians, Treatment, Breast Cancer, Hardware Diagnostics, Internal Medicine, Laparoscopic Surgery, Informatics, Cardiology, Neurology
Education
Virginia Commonwealth University School of Medicine 1989 — 1991
MD, Post Graduate Studies in Surgery and Surgical Oncology
Brown Medical School 1988 — 1989
MD, Post Graduate Studies Resident in Surgery
Brown Medical School 1987 — 1988
MD, Post Graduate Studies Surgical Oncology Research Fellow for Dr. Harold Wanebo
Brown Medical School 1985 — 1987
MD, Post Graduate Studies Resident in Surgery
Virginia Commonwealth University School of Medicine 1981 — 1985
MD
Virginia Polytechnic Institute and State University 1977 — 1980
MS, Chemistry
University of South Florida 1972 — 1977
BS, Chemistry
Medical Device Industry 2008 - Present
Medical Device 2008 - Present
Education
San Jose State University
Medical Device Industry July 2010 - Present
Euromed Inc September 2005 - June 2010
ConvaTec: A Bristol-Myers Company November 1998 - February 2003
ConvaTec 1995 - 1998
Skills
Medical Devices, Wound Care, Surgery, Global Marketing, Business Strategy, FDA, Clinical Research, Voice of the Customer, Capital Equipment, Management, Biotechnology, Clinical Trials, Orthopedic, Marketing Strategy, Marketing, Strategy, Product Development, Healthcare
Education
Cornell University
BS, Nursing
New York University
MA, Health Admin/Nursing Admin
SLC Commercial, Inc. 2005 - Present
Medical Device Industry 1976 - 2005
Skills
Real Estate, Disposition, Property, Sales, Shopping Centers, Commercial Real Estate, Sellers, REO
Education
CCIM Institute
CCIM
University of Florida
BSBA, Marketing & Finance
Genpact 2007 - Present
Parson Consulting 2000 - 2007
Revenue Management Associates, LLC 1999 - 2000
REL Consultancy Group 1988 - 1998
Medical Device Industry 1984 - 1988
International Paper 1976 - 1984
Skills
Business Process..., Acquisition Integration, Change Management, Process Improvement, Outsourcing, Management Consulting, Business Process..., Business Transformation, Finance Transformation, Business Analysis, Shared Services
Education
Amos Tuck School of Business at Dartmouth College 1974 — 1976
MBA, Finance
University of Connecticut 1969 — 1973
BS, Business Administration
Ramapo High School 1965 — 1969
FlexDex Surgical June 2014 - Present
HistoSonics Inc. 2009 - Present
Medical Device Industry 2007 - Present
MedTech Innovations, LLC January 2006 - Present
Sontra Medical Corp May 1992 - December 2006
Zimmer Spine - Formerly Endius Inc. (Start Up) 1996 - 2002
Endius, Inc. 1996 - 2002
UltraCision 1988 - 1996
UltraCison 1988 - 1996
MedChem Inc 1991 - 1995
Skills
Medical Devices, Orthopedics, Spine, Product Development, Commercialization, Neurosurgery, FDA, Surgery, Strategic Planning, Start-ups, Clinical, Life Sciences, Team Building, Clinical Trials, Patents, Manufacturing, Intellectual Property, Mergers, Business Planning, Sales Management, Marketing Strategy, Product Launch, New Business Development, Contract Negotiations, Product Management, Venture Capital, Negotiation, Biotechnology, Market Research, Healthcare, Biomedical Engineering, Contract Negotiation, Organizational..., Marketing Management, Competitive Analysis, Public Speaking, Regulatory Affairs, R&D, Clinical Development, Entrepreneurship, Technology Transfer, Business Strategy, Strategy Development, Drug Delivery, Market Development, Medical Device Product..., ISO 13485, Surgical Instruments, Disposables, Capital Equipment
Education
Kent State University 1964 — 1972
BA, MS, Ph.D., Biology, Chemistry
Thomas Davison
Quality & Regulatory Consulting, LLC 2000 - Present
Medical Device Industry 1978 - Present
TriPath Imaging, Inc 1997 - 2000
Cardiovascular Diagnostics 1995 - 1997
Bayer Corp 1993 - 1995
Miles Laboratories 1981 - 1992
Skills
Quality Systems, Validation, Process Validation, Medical Devices, Design Control, 510 K, PMA, CAPA, GMP, cGMP
Education
Indiana University-Purdue University at Indianapolis 1974 — 1977
University of Massachusetts Boston 1972 — 1974
BA, Biology
Dymedex Consulting December 2010 - Present
Medical Device Industry April 2010 - December 2010
Boston Scientific October 2005 - April 2010
Velocimed October 2004 - October 2005
Guidant June 2002 - September 2004
Skills
Market Development, Urology, Interventional..., Segmentation, Voice of the Customer, Cardiac Surgery, Strategy, Nephrology, Vascular Surgery, Medical Devices, Commercialization, Product Launch, Market Analysis, Product Marketing, Surgery, Marketing Strategy, Capital Equipment, Cardiology, Market Research, Program Management
Education
UCLA Anderson School of Management 2001 — 2003
MBA, Marketing & Strategy
University of Minnesota-Twin Cities 1992 — 1996
BS Chemical Engineering, Chemical Engineering - Biochemical Emphasis
Carmel Diagnostics February 2014 - Present
Medical Device Industry 2011 - Present
Thermogenesis 2008 - 2011
Trig Medical 2006 - 2008
SightLine-Stryker GI 2003 - 2006
Biogenics 2000 - 2003
MediVision 1996 - 2000
Skills
Medical Devices, X-ray imaging, Ultrasound imaging, multidisciplinary..., Electro-mechanical, Cord-Blood Banking, Disposables, Engineering, Imaging, Medical Imaging, X-ray, Ultrasound, Biomedical Engineering, ISO 13485, Production, Quality Assurance, FDA, Product Development, R&D, Validation, Cross-functional Team..., Strategic Planning, CAPA, Commercialization, Quality Systems, Diagnostics, 510 K, Operations, Hardware Diagnostics, Design Control, Digital Imaging, Business Development, Quality System, Quality Auditing, V&V, Design for Manufacturing, Market Development, ISO 14971, Management, Regulatory Submissions, Capital Equipment, Global Marketing, Surgery, Quality Management, Cardiology, Surgical Instruments, 21 CFR Part 11, Product Lifecycle..., Technology Evaluation, Optics
Education
New York University - Polytechnic School of Engineering 1982 — 1983
M.Sc., Electronic Engineering
New York University - Polytechnic School of Engineering 1980 — 1982
B.Sc, Electronic Engineering/Biomedical
Medical Device Industry November 2014 - Present
CyVek September 2013 - November 2014
Roche Diagnostics March 2010 - September 2013
Kenexa, an IBM Company December 2008 - February 2010
Unbelieva-Bills July 2005 - November 2009
Bayer Diagnostics January 2000 - June 2005
Bayer Diagnostics May 1997 - December 1999
Chiron Corporation January 1995 - April 1997
Ciba Corning April 1991 - December 1994
Ciba Corning July 1989 - March 1991
Skills
Medical Devices, Product Development, Strategic Planning, Customer Service, Healthcare, Sales Management, Cross-functional Team..., New Business Development, Product Launch, Account Management, Hospitals, Capital Equipment, Business Strategy, Sales Operations, Change Management, Quality System, Market Development, Leadership, Project Management, Sales, Management, Strategy, Pharmaceutical Industry, Life Sciences
Education
Rutgers, The State University of New Jersey-New Brunswick 1985 — 1999
BS, Sports Management
University of Phoenix
Master of Business Administration (MBA), Small Business Administration/Management
Maquet Cardiovascular previously Boston Scientific Corporation/Guidant Corporation 2004 - 2011
Conceptus 2001 - 2004
Medical Device Industry 1995 - 2001
Education
Saint Mary's College of California 2011 — 2013
Master of Business Administration (MBA)
San Diego State University-California State University
Bachelor of Science, Mechanical Engineering
University of Wisconsin
Bachelor of Science, Social Sciences
Medical Device Industry 2015 - Present
Teleflex, Inc. (previously, Vidacare, LLC) 2012 - 2015
B. Braun Medical 2008 - 2012
Advanced Sterilization Products (ASP) 2006 - 2007
Smiths Medical (Previously, MedEx, Inc.) 2004 - 2006
Skills
Operating Room, Capital Equipment, Medical Devices, Sales, Sales Operations, Interventional Radiology, Surgery, Hospitals, Sales Management, Disposables, Surgeons, Emergency Medical..., Vascular Access, Critical Care, Intensive Care, Post Anesthesia Care, Anesthesia, Marketing, Marketing Communications, Integrated Delivery..., Group Purchasing..., Hos
Education
University of Hawaii at Manoa
Bachelor of Business Administration (B.B.A.)
Medical Device Industry July 2015 - Present
Mizuho OSI, Inc. July 2000 - July 2015
Aesculap 1996 - 2000
Surgical Dynamics 1992 - 1996
Skills
Medical Devices, ISO 13485, FDA, Quality System, Orthopedic, CE marking, CAPA, ISO 14971, 21 CFR, Quality System..., IEC 60601, Surgical Instruments, Change Management, FDA GMP, Continuous Improvement, Design Control, GMP, Manufacturing, Quality Assurance, Regulatory Affairs, V, Validation, Orthopedics
Education
Saint Mary's College of California 2004 — 2006
Business
AMRESCO LLC August 2014 - Present
-- 2015 - 2015
-- 2015 - 2015
Kelly Services January 2014 - May 2014
Medical Device Industry 2014 - 2014
Boehringer Ingelheim May 2012 - December 2013
Bristol-Myers Squibb, Princeton, New Jersey January 2004 - May 2012
Lockwood Greene May 2000 - December 2003
Skills
Validation, GMP, Sop, Commissioning, Manufacturing, 21 CFR Part 11, Cross-functional Team..., Change Control, V&V, CAPA, GAMP, FDA, Biopharmaceuticals, Chromatography, GxP, Pharmaceutical Industry, Cleaning Validation, Aseptic Processing, Lean Six Sigma Basics, LIMS, SOP
Education
Rutgers UniversityNew 1996 — 2000
B.A, Biology
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
Bachelor's degree, Biology, General
FDA August 1991 - Present
US Army May 1986 - September 1994
US Patent and Trademark Office July 1989 - August 1991
Medical Device Industry 1983 - 1987
Skills
ISO 13485, FDA, Regulatory Affairs, CAPA, Quality System, Medical Devices, Validation, GMP, V&V, Biomedical Engineering, Quality Assurance, International Medical..., Medical Device Auditing, Regulatory Submissions, ISO 14971, Biotechnology, Regulatory Requirements, Quality Management
Education
University of Virginia 1987 — 1989
Master's Degree, Biomedical/Medical Engineering
Pennsylvania State University - Main Campus 1982 — 1986
Bachelor of Science (BS), Molecular and Cell Biology and Engineering Sciences
medical device industry 2007 - 2009
St.Francis Medical Technologies November 2003 - May 2007
Education
University of Illinois at Chicago 1984 — 1987
M.S., Nursing
Focal Therapeutics June 2014 - Present
Medical Device Industry 2005 - Present
Vertos Medical Inc July 2009 - September 2014
Alsius Corporation April 2005 - May 2009
Zoll 2009 - 2009
TI Woundcare 2000 - 2002
Skills
Customer Service, Medical Devices, Healthcare, Capital Equipment, Sales Operations, ISO 13485, FDA, Surgeons, Selling, Sales Management, Hospitals, Cross-functional Team...
Education
California State University-Fullerton 1973 — 1977
English Literature
Medical Device Industry January 2005 - Present
Medical and Healthcare Segments 1993 - 2005
Bioject Inc. 2002 - 2004
Power Medical Interventions 2000 - 2002
Dade Behring September 1998 - December 2000
Biochem Immunosyatems, Inc. 1994 - 1998
Rusch Inc. - Teleflex 1991 - 1993
ENtech, Inc. 1986 - 1991
Biosearch Medical Products, Inc. 1976 - 1986
Skills
Biomedical Engineering, ISO 13485, Medical Devices, FDA, Healthcare, Quality System, Cross-functional Team..., Regulatory Affairs, CAPA, Quality Assurance, Product Development, Hematology, GMP, V&V, Biotechnology, R&D, Product Launch, Design Control, Lifesciences, Pharmaceutical Industry, Validation
Education
BRHS - West
High Point University
BS, Biological Sciences
Medical Device Industry Engineering FellowCordis1990 - 2010
Cordis 1999 - 2007
Skills
DMAIC, FDA, Cross-functional Team..., Process Engineering, Six Sigma, CAPA, Design Control, Design of Experiments, V&V, Engineering, Root Cause Analysis, ISO 13485, Minitab, Lean Manufacturing, Manufacturing, Process Simulation, Medical Devices
Education
University of Miami 1995 — 1997
MS, Industrial Engineering
Florida International University 1989 — 1992
MBA, Management Science
University of Miami 1982 — 1986
BS, Microbiology
Bruin Biometrics, LLC July 2013 - Present
Medical Device Industry May 2012 - Present
Acutus Medical, Inc. 2014 - 2015
Acutus Medical, Inc. 2014 - 2015
CareFusion December 2009 - April 2012
Cardinal Health June 2004 - December 2009
Alaris Medical Systems August 1998 - June 2004
Gen-Probe, IMED, and Gensia-Automedics 1989 - 1998
Infrasonics 1981 - 1989
Skills
Medical Device Product..., Cross-functional Team..., Team Leadership, Medical Devices, Product Development, Program Management, Infusion, Ventilators, in vitro diagnostics, IVD, Mechanical Ventilation, CPAP, Respiratory Products, Pulse Oximetry, Patient Monitoring, IV therapy, Intravenous therapy, Systems Engineering, Embedded Systems, FDA, 510k, Design Control, patient controlled..., PCA, medical products, Patient Safety, Hardware Development, Biotechnology, Bioengineering, Situational Leadership, Disposables, Consumables, Team Top Gun Leadership..., IV, Home Infusion, ISO 13485, Medical Monitoring, CASE, Six Sigma, Testing, ISO 14971, Capital Equipment, Quality System, CAPA, 21 CFR Part 11, Validation, Process Simulation, Product Management, GMP, V&V
Education
University of California, San Diego
Bachelor's degree (BS), Biomedical/Medical Engineering, UCSD
Professional Development