Medstone International
Industry: Company
DescriptionHeadquarters: Aliso Viejo, CA Founded: 1984 Parent organization: HealthTronics, Inc. Subsidiary: Medstone International Ltd.
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Medstone International Employees
Writers Assist Inc, Minnesota, Scott Hartmann, CEO Writing Assistance, Inc December 2010 - Present
Orange County Calif June 2007 - Present
Various clients 1990 - Present
Koyo Sushi August 2009 - June 2010
Ceradyne Inc March 2004 - April 2007
R & D/Technical January 2003 - February 2004
Medstone International March 2001 - December 2002
Toolex USA March 1996 - July 2000
Ricoh Electronics June 1990 - February 1996
Skills
Copy Editing, Creative Writing, Instructional Design, Proofreading, Technical Writing, Software Documentation, Manufacturing, Visio, Quality Assurance, Testing, Training, Troubleshooting, Engineering, Quality Control, Process Improvement, Product Development, Analysis, Technical Documentation, FDA
Education
Orange Coast College 1980 — 1982
Associate Degree; Degree, Manufacturing Technology
Orange Coast College 1980 — 1982
Associate Degree, Manufacturing Engineering Technology/Technician
Senior Aerospace Absolute Manufacturing February 2015 - Present
Zodiac Aerospace October 2013 - February 2015
Zodiac Aerospace January 2004 - October 2013
C&D Zodiac March 2000 - January 2004
Medstone International April 1988 - January 2000
Skills
Aviation, Program Management, Aerospace, Aircraft, Systems Engineering, Root Cause Analysis, Engineering, MRP, Project Management
Education
Saddleback College
Business Administration and Management, General
Axonics Modulation Inc. May 2014 - Present
Boston Scientific December 2012 - May 2014
Vessix Vascular, Inc. 2010 - December 2012
CardioPolymers Inc. 2009 - 2010
Cardiac Science 2006 - 2009
Cardiac Science 2000 - 2005
Medstone International 1991 - 2000
Cardiac Science 1991 - 1997
Skills
FDA, Signal Processing, Clinical Trials, Product Development, Medical Devices, R&D, Biomedical Engineering, Product Management, Mergers, Product Launch, Venture Capital, Commercialization, Design Control, Market Development, Cross-functional Team..., Quality System, Biotechnology, ISO 13485, Leadership, Strategy, Validation, Mergers & Acquisitions, Intellectual Property
Education
Missouri University of Science and Technology 1981 — 1983
MS
Indian Institute of Technology, Kanpur 1976 — 1981
BS
Bergeson Regulatory Consulting September 2007 - Present
BioMimetic Therapeutics, Inc. January 2011 - February 2012
ReVision Optics, Inc. July 2006 - September 2007
HealthTronics, Inc. July 1998 - June 2005
Medstone International July 1998 - June 2003
Imagyn Medical Technologies February 1996 - July 1998
Medtronic, Heart Valve Division February 1994 - February 1996
Eli Lilly-Hybritech Division July 1992 - February 1994
Baxter Healthcare, Edwards LIS February 1988 - July 1992
Skills
FDA, Medical Devices, Regulatory Affairs, Quality System, Regulatory Submissions, Biotechnology, Quality Assurance, CAPA, Regulatory Requirements, Clinical Development, Design Control, Clinical Trials, Auditing, Validation, Product Development, Commercialization, PMA, Clinical Research, GMP, R&D, Quality Auditing, Quality Management, Compliance, Sop, 510 K, IDE, Regulatory Strategy, GLP, GCP, Inspection, Document Management, CTMS, Strategy, QSR, Clinical, Clinical Trial..., Humanitarian Device..., Regulatory Product..., FDA Panel Approval, cGMP
Education
Cal Poly Pomona 1981 — 1983
Partial MBA, Marketing
University of Arizona 1974 — 1976
MSc, Toxicology/Chemistry
University of Arizona 1971 — 1974
BS, Microbiology/Chemistry
The Dow Chemical Company Process Refrigeration Technology LeaderDow ChemicalNovember 2000 - January 2015
Dow Chemical March 1990 - November 2000
Medstone International July 1988 - May 1992
Skills
Project Management, Six Sigma, Product Development, Leadership, Process Engineering
Education
McNeese State University
Associate of Science (A.S.), Electrical and Electronics Engineering
McNeese State University
Associate of Science (A.S.), Electromechanical Instrumentation and Maintenance Technologies/Technicians
Alcon Laboratories, Inc. January 1990 - July 2010
Medstone International June 1989 - December 1989
Philips May 1982 - May 1989
Philips July 1970 - May 1982
Skills
Medical Devices, Process Improvement, Pharmaceutical Industry, Product Development, Cross-functional Team..., R&D, Six Sigma, Manufacturing, FDA, Validation, V&V, Product Management, ISO 13485, Quality System
Education
Rensselaer Polytechnic Institute 1975 — 1977
MSEE, Engineering Administration
Union College 1968 — 1970
BSEE, Electrical Engineering
Farmingdale State University of New York 1966 — 1968
AS, Enginering Science
WellPrepared.com May 2015 - Present
HEALTHandMED.com August 2007 - Present
MYO, LLC 2005 - 2007
Ziehm Imaging 2003 - 2004
Medstone International 2001 - 2003
Life-Tech, Inc 1998 - 2001
Utah Medical Products 1997 - 1998
Skills
Supplements, Marketing, Entrepreneurship, E-commerce, Public Speaking, Sales, Strategic Planning, Data Analysis, Sales Management, Product Development, Online Advertising, Customer Service, Analytics, Management, Microsoft Office, SEM, Online Marketing
Education
Brigham Young University 1995 — 1997
MBA, Marketing & Entrepreneurship
University of Iowa 1988 — 1991
BS, Biomedical Engineering
Consulting Services March 2012 - Present
SEDLine, Inc. / Masimo Corporation December 2009 - March 2012
Extomed, LLC December 2006 - December 2009
Quest Diagnostics - Nichols Institute Diagnostics February 2006 - December 2006
Respironics 2003 - 2006
Applied Medical 1998 - 2003
Medstone International 1994 - 1998
Newport Medical Resources 1988 - 1994
Skills
Medical Devices, Quality Systems, Regulatory Affairs, ISO 13485, FDA, Clinical, 510 K, Validation, Design Control, Manufacturing, QSR, Life Sciences, Compliance, cGMP, ISO, GMP, Quality Assurance, Biotechnology, CAPA, Six Sigma, ISO 14971, Lean Manufacturing, Continuous Improvement, 21 CFR Part 11, SPC, Auditing, Healthcare, Strategic Planning, Start-ups, Cross-functional Team..., FMEA, Process Validation, Orthopedics, GLP, Requirements Analysis, Risk Management, Biomedical Engineering, Clinical Development, Documentation, DMAIC, Analysis, Product Development, PMA, FDA Warning Letter..., FDA 483 Response and..., FDA IDE, Health Canada ITA, Combination Products, Quality System, Quality Control
Education
California State University-Dominguez Hills 1992 — 1994
MS, Quality Assurance
National Institute of Technology Karnataka 1981 — 1985
BSEE, Electrical Engineering
Rajkumar College, Rajkot 1969 — 1981
High School
Neurocrine Biosciences October 2000 - Present
Biopure Corporation 1997 - 2000
Hybridon 1996 - 1997
Alliance Pharmaceuticals 1989 - 1996
Medstone International 1988 - 1989
Allergan 1982 - 1988
Skills
Data Management, Biostatistics, Pharmaceutical Industry, Clinical Trials, GCP, Oracle Clinical, Clinical Development, Drug Development, Clinical Research, EDC, Protocol, Clinical Study Design, Regulatory Affairs, CRO, SAS, Sop, Regulatory Submissions, CTMS, Lifesciences
Education
California State University-San Bernardino
B.S., Mathematics
Oregon State University
M.S., Statistics
ev3 July 2006 - December 2008
Invitrogen February 2004 - July 2006
Invitrogen June 2002 - December 2003
Cardiac Science June 2000 - June 2002
Medstone International June 1996 - July 2000
Ernst & Young May 1994 - June 1996
Skills
Mergers, Managerial Finance, Cost Accounting, Consolidation, US GAAP, Finance, Sarbanes-Oxley, Internal Audit, Corporate Tax, CPA, Financial Reporting, Forecasting, SEC filings, Accounting, Auditing, Financial Analysis, Acquisition Integration, Internal Controls, Financial Modeling, Sarbanes-Oxley Act
Education
Brigham Young University 1991 — 1992
Masters
Brigham Young University 1988 — 1991
Bachelors
Intelligent Energy January 2009 - Present
Vesta Medical April 2004 - January 2009
Various Companies In The Orange County Area January 2003 - April 2004
American Immuno Tech April 1999 - January 2003
Sunrise Medical July 1998 - April 1999
Medstone International December 1996 - July 1998
Southern California Hydraulic Engineering January 1992 - December 1996
Skills
Over 16 years..., Design for Manufacturing, Solidworks
Education
California Polytechnic State University-San Luis Obispo 2000 — 2005
BS, Mechanical Engineering Technology
West Los Angeles City College
AS, Aircraft Technology
Inceptus Medical September 2012 - Present
CR Bard (formally SenoRx) November 2009 - July 2012
Quantum Corp. (formally ATL Products) December 1997 - November 2009
Abacus Design and Development March 1995 - December 1997
Laparomed/Advanced Surgical November 1990 - March 1995
Medstone International January 1987 - November 1990
Shiley/Pfizer October 1980 - December 1986
American Edwards Laboratories June 1978 - September 1980
Ford Aeronutronics September 1977 - June 1978
American Edwards Laboratories September 1975 - August 1977
Skills
Solidworks, ProE, Machinist, Product Launch, Design Control, Design of Experiments, Manufacturing..., Solid Modeling, Injection Molding, FDA, Microsoft Excel, Microsoft Word, Sheet Metal, Testing, Cross-functional Team..., Manufacturing, CAD, Pro Engineer, Machining, SolidWorks
Education
Long Beach City College 1969 — 1972
Associate of Arts, Mechanical Design
Lakewood High School 1966 — 1969
Steward Health Care July 2015 - Present
Medical Imaging Innovations March 2015 - Present
Mallinckrodt Pharmaceuticals January 2012 - September 2014
ARAMARK July 2010 - February 2012
ARAMARK February 2007 - August 2010
ARAMARK February 2004 - February 2007
Medstone International January 2003 - February 2004
Liebel-Flarsheim July 1992 - December 2002
X-Ray Incorporated of Rhode Island (XRI) August 1977 - August 1992
Skills
Medical Devices, Healthcare, Customer Service, Radiology, Medical Imaging, X-ray, Leadership, Project Management, Capital Equipment, Hospitals, Sales, Informatics, Management, Market Development, Selling, Urology, Sales Management, Sales Process, Product Launch, Sales Operations, Cross-functional Team..., Orthopedic, Cardiology, Hardware Diagnostics, Orthopedics
Education
Saint Joseph's College 2004 — 2010
BSGS, Buisiness Management
Chaminade University of Honolulu
Business
Outsourcing Services (Pvt) Ltd 2006 - Present
Point 360 2009 - 2010
Kiosk Concepts, LLC 2004 - 2009
Celerity 2002 - 2005
Collectors Universe 1999 - 2002
Fujitsu Business Coomunication Systems 1998 - 1999
Unit Instuments 1996 - 1998
AST Research 1991 - 1995
Medstone International 1989 - 1991
Krupp/Taylor USA 1984 - 1989
Skills
Start-ups, Strategic Planning, Project Management, Product Development, Process Improvement, Product Management, Cross-functional Team..., Management, Mergers, Budgets, Business Intelligence, IT Strategy, Strategy, Program Management, Microsoft SQL Server, Mergers & Acquisitions
Education
California State University-Dominguez Hills 1977 — 1978
MBA, Business Adminstration
Northrop University 1973 — 1976
BSc, Aviation Engineering Technology