ORATEC Interventions
Industry: Company
DescriptionFounded: 1993 Parent organization: Smith & Nephew
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ORATEC Interventions Employees
EarLens February 2015 - Present
Sonitus Medical Inc. November 2012 - January 2015
NeuroPace December 2010 - November 2012
TriReme Medical November 2008 - December 2010
Thoratec June 2008 - November 2008
EV3 (Foxhollow Technologies) 2006 - 2008
Kerberos Proximal Solutions 2006 - 2006
Epicor 2003 - 2006
RITA Medical Systems 2001 - 2002
Oratec Interventions 1999 - 2001
Skills
Cross-functional Team..., Medical Devices, Manufacturing, GMP, FDA, Process Improvement, ISO 13485, CAPA, Design Control, Validation, R&D, Quality System, Engineering, V&V, ISO 14971
Education
California State University-East Bay 2009 — 2011
M.P.A, Health Care Administration
California State University-East Bay 1994 — 1998
BA, Human Development
Bay Area Medical Device Startup May 2014 - Present
Velomedix April 2010 - January 2014
SurgRx May 2004 - February 2010
Oratec Interventions May 1998 - June 2003
Skills
ISO 13485, Medical Devices, Quality Assurance, Validation, Document Management, Visio, Databases, Software Documentation, Process Improvement, Manufacturing, Quality Control, Training, Quality System, FDA, CAPA, Design Control
Education
San Jose State University
Bachelor of Applied Science (B.A.Sc.), Criminal Justice/Law Enforcement Administration
Strategic Reimbursement Consulting, Inc January 2002 - Present
ORATEC Interventions, Inc / Smith & Nephew - Endoscopy January 1999 - January 2002
Oratec Interventions 1999 - 2002
OrthoLogic (now called Capstone Therapeutics) 1995 - 1999
HealthSouth Rehabilitation Corporation January 1992 - January 1995
Candlelight Care Center January 1991 - January 1992
Skills
Spine, Operating Room, Strategy, Sales, Orthopedic, Medical Devices, Training, Marketing, Product Marketing, Disposables, Healthcare Industry, Product Launch, Sales Operations, Market Research, Market Development, Healthcare, Surgeons, Neurosurgery, Orthopedics, Surgery, Managed Care, Product Development, Surgical Instruments, Health Policy, Capital Equipment
Education
Northwestern University 1987 — 1991
Libertyville High School
Sterigenics June 2003 - Present
Cholestech June 2001 - June 2003
Oratec Interventions 2000 - 2001
LocalMed 1996 - 1998
Skills
Pharmaceutical Industry, Product Development, Cross-functional Team..., R&D, Lifesciences, Quality Assurance, Medical Devices, Contract Negotiation, Account Management, Hardware Diagnostics, Leadership, Sales Management, New Business Development, Management, Sales, Training, Sales Process, Quality Control, Lead Generation, Life Sciences, Quality System, FDA, ISO 13485
Education
University of California, Santa Barbara 1996 — 2000
BS, Biopsychology
K2 Marketing 2010 - Present
Smith & Nephew Endoscopy 2006 - 2010
Smith & Nephew Endoscopy 2002 - 2006
Oratec Interventions 2001 - 2002
Orquest 1997 - 2001
Skills
Product Development, Strategic Planning, Medical Devices, Business Development, Product Launch, Market Development, Commercialization, Orthopedics, Capital Equipment, Product Marketing, Cross-functional Team..., Management, Start-ups, Product Management
Education
Santa Clara University - Leavey School of Business 1997 — 1999
MBA, Marketing
Harvard University 1985 — 1989
BA, History and Economics
Intersect ENT August 2013 - Present
Arstasis January 2011 - August 2013
Satiety, Inc. October 2008 - December 2010
ELA Marketing Communications March 2008 - September 2008
FoxHollow Technologies December 2006 - January 2008
FoxHollow Technologies; acquired by ev3, all programs terminated by ev3 3/08, and facility closing 2006 - 2008
Coapt Systems November 2004 - December 2006
Baxter BioScience March 2003 - November 2004
Cohesion Technologies September 2002 - March 2003
Oratec Interventions April 1999 - September 2002
Skills
Medical Devices, Marketing Communications, Marketing, Brand Development
Education
Lehigh University 1985 — 1989
Bachelor of Science, Economics
Zimmer Biomet September 2011 - Present
Custom Spine 2009 - 2011
ReGen Biologics 2009 - 2009
Smith & Nephew Endoscopy 2002 - 2009
Oratec Interventions 2000 - 2002
Precision Inc. 1992 - 2000
DJO Global 1992 - 1999
Skills
Orthopedics, Sports Medicine, Operating Room, Medical Devices, Spine, Capital Equipment, Surgery, Orthopedic, Product Launch, Surgeons, Disposables, Surgical Instruments, Market Development, FDA, Urology, Biologics, Sales Force Development, Neurosurgery, Medical Sales, Capital Equipment Sales, Interventional Radiology, ENT
Education
State University of New York College at Plattsburgh 1982 — 1986
BS
TBD/ 2009 - Present
Boston Scientific 1998 - 2008
Oratec Interventions 1996 - 1997
Guidant Corp - Advanced Cardiovascular Corp 1985 - 1996
Ferix Corporation 1984 - 1985
Signetics 1980 - 1984
Skills
Team Building, Cycle Time Reduction, Medical Devices, Yield, CAPA, FDA, Quality System, R&D, Lean Manufacturing, SPC, Regulatory Affairs, Manufacturing..., 21 CFR Part 11, Root Cause Analysis, Quality Assurance, DMAIC, Cross-functional Team..., Six Sigma, Design for Manufacturing, Design of Experiments, Minitab, ISO 14971, Electronics, GMP, Commercialization, FMEA, ISO, Manufacturing Operations, Manufacturing, Start-ups, Continuous Improvement
Education
San Francisco State University, College of Business 1967 — 1971
BA, Management Science
Heritage Texas Properties August 2011 - Present
Medartis Inc 2008 - January 2011
Medtronic Spine 2003 - 2004
Oratec Interventions May 1999 - May 2003
Stryker 1997 - 1999
DePuy Spine 1995 - 1997
Synthes 1986 - 1994
Skills
Orthopedic, Spine, Product Launch, Operating Room, Interventional Radiology, Medical Devices, Trauma, Hospitals, Ambulatory Surgery, Sales, Sales Management, Account Management, Biologics, Capital Equipment, Disposables, Market Development, Selling, Pain Management, Sales Operations
Education
Stetson University
BBA, Economics
Stetson University
BBA, Business/Economics
The FDA Group, LLC September 2013 - Present
Oregon Bioscience Association January 2007 - Present
SJR Associates January 2003 - Present
Apieron Biosystems August 2004 - December 2005
Natus Medical Inc. April 2000 - October 2002
Oratec Interventions August 1998 - April 2000
Biocircuits Corporation September 1989 - June 1998
Skills
FDA, Medical Devices, Regulatory Affairs, Regulatory Submissions, ISO 13485, ISO 14971, Quality System, Quality Assurance, Design Control, R&D, Product Development, CAPA, 21 CFR Part 11, Clinical Research, Biotechnology, Start-ups, Validation, Healthcare, V&V, Software Documentation, Lifesciences, Cross-functional Team..., Strategy, FDA submissions, Testing, Commercialization, Quality Auditing, GMP, Hardware Diagnostics, Technology Transfer, Product Launch, Clinical Trials, Market Development, Regulatory Strategy..., Project Management
Education
Shoreline Community College
AA, Medical Laboratory Technology
St. Mary's College of California
BA, Health Services Administration
Pivot Medical June 2013 - Present
Pivot Medical June 2009 - June 2013
Pivot Medical May 2008 - June 2009
Pivot Medical May 2007 - May 2008
ArthroCare Corporation October 2005 - May 2007
Smith and Nephew Endoscopy May 2003 - October 2005
Oratec Interventions May 2002 - October 2003
Amira Medical February 1998 - March 2002
Roche Corporation (Amira Medical Corporation) 1998 - 2002
Skills
Medical Devices, ISO 13485, Capital Equipment, Commercialization, Design Control, Orthopedic, Biomedical Engineering, Product Launch, Market Development, FDA, Product Development, Spine, Biotechnology, Start-ups, Operating Room, Disposables, AutoCAD, Product Design, Design for Manufacturing, Cross-functional Team..., Product Marketing, Product Management, Quality System, Validation, Sales Operations, Surgical Instruments, R&D, Value Stream Mapping, Surgeons, CAPA, New Business Development, Catheters, Hardware Diagnostics, V&V, Surgery, Injection Molding, Biomaterials, Design of Experiments, ISO 14971, Clinical Trials, Medical Education, Orthopedics
Education
California State Polytechnic University-Pomona 1991 — 1997
BS, Mechanical Engineering
Goode Surgical July 2011 - Present
Pylant Medical.....Arthrex Distributor August 2009 - September 2011
pegasus biologics February 2008 - April 2009
Oratec Interventions January 1994 - January 1999
Stryker Endoscopy 1989 - 1999
Skills
Spine, Operating Room, Surgical Instruments, Orthopedic, Capital Equipment, Disposables, Medical Devices, Surgeons
Education
University of Colorado at Boulder 1981 — 1986
BS, Pre medical sciences & psychology
Western State College 1981 — 1982
Gulf Atlantic Surgical LLC August 2009 - Present
Smith & Nephew Endoscopy February 2002 - August 2009
Smith and Nephew 2002 - 2009
Oratec Interventions February 2000 - May 2002
Arthrex 1995 - 2000
Skills
Medical Devices, Orthopedics, Surgeons, Capital Equipment, Surgery, Hospitals, Sports Medicine, Clinical Research, Start-ups, Operating Room, Product Development, Surgical Instruments, Disposables, Commercialization, Biotechnology, Biomedical Engineering, Cardiology, CRM, Endoscopy, Diabetes, ENT, FDA, General Surgery, Global Marketing, Healthcare, Leadership, Lifesciences, Market Development, Medical Sales, Medicine, OB/GYN, Neurosurgery, Sales Management, Selling, Spine, Orthopedic, Urology, Product Launch, Strategy, Sales Effectiveness, Sales, Vascular, Managed Care, Pharmaceutical Sales, Sales Operations, Sales Force Development, Interventional Radiology, Wound Care, Operating Room Sales, Surgical Device Sales
Education
Florida International University 1983 — 1985
Hospitality Management, Business/Hospitality Management
University of Alabama 1980 — 1983
Business
ZipLine Medical May 2014 - Present
Pivot Medical/Stryker February 2010 - May 2014
Spinal Kinetics 2005 - 2009
Xoft, Inc. 2003 - 2005
Sanarus Medical December 1999 - September 2002
Hemox Therapeutics November 1998 - September 2002
Oratec Interventions October 1996 - October 1998
Indigo Medical January 1994 - October 1996
Laserscope Surgical Systems October 1992 - January 1994
Medical Innovations Corporation December 1989 - October 1992
Skills
Product Development, Manufacturing, ISO 13485, Project Management, Medical Devices, Design Control, Solidworks, Design of Experiments, FDA, Design for Manufacturing, Engineering, R&D, Product Launch, Cross-functional Team..., Engineering Management, Biomedical Engineering, Start-ups
Education
Santa Clara University 1993 — 1997
MSEM
California Polytechnic State University-San Luis Obispo 1984 — 1989
BSME, Engineering
MicroVention, Inc June 2009 - Present
Concentric Medical 2008 - 2009
Boston Scientific, Neurointerventional Division 2006 - 2008
Experien Group 2004 - 2006
Guidant, Endovascular Solutions 2003 - 2004
Timi3 Systems 2001 - 2003
Oratec Interventions 2000 - 2001
CardioThoracic Systems (CTS) 1997 - 2000
Boston Scientific / Target Therapeutics 1993 - 1997
Advanced Cardiovascular Systems 1984 - 1993
Skills
Medical Devices, FDA, CE marking, ISO 13485, Regulatory Affairs, CAPA, Quality System, PMA, Worldwide Regulatory...
Education
Pomona High
San Francisco State University
Bachelor's degree
CytoSorbents May 2014 - Present
Worldwide Clinical Trials, Inc. June 2010 - Present
Cytosorbents, Inc 2014 - 2015
Cytosorbents, Inc 2014 - 2015
PPD April 2006 - April 2009
Novartis February 2004 - April 2006
ORATEC Interventions January 2000 - January 2002
Corvascular January 1999 - January 2000
InControl January 1997 - January 1999
Department Biostatistics, Medical College of VA January 1989 - January 1997
Skills
Clinical Trials, CRO, Oncology, FDA, Clinical Research, Pharmaceutical Industry, GCP, Biostatistics, Data Management, Clinical Development
Education
Medical College of Virginia 1985 — 1995
PhD, Biostatistics
Virginia Commonwealth University 1985 — 1995
MS, Computer Science
University of Maine 1973 — 1975
MA, Mathematics
William Paterson College
BA, Mathematics