Guided Delivery Systems, Inc.
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Guided Delivery Systems, Inc. Employees
Cordis April 2013 - Present
Adept Technology June 2012 - November 2012
Johnson & Johnson June 2011 - November 2011
Guided Delivery Systems, Inc. June 2010 - September 2010
Guided Delivery Systems, Inc. July 2009 - September 2009
Simpson Strong-Tie June 2008 - September 2008
Skills
Rapid Prototyping, Matlab, Medical Devices, Solidworks, Market Research, Microsoft Office, Microsoft Excel, PowerPoint, Labview, Microsoft Word, Research, Pro Engineer, Financial Analysis, Finite Element Analysis, Manufacturing, Testing, AutoCAD, Analysis, Mechanical Engineering, SolidWorks
Education
University of California, San Diego 2006 — 2012
BS, Mechanical Engineering
SentreHEART, Inc. September 2012 - February 2015
NDS Surgical Imaging November 2011 - August 2012
Guided Delivery Systems, Inc. April 2007 - November 2011
ArrayComm, LLC April 2005 - April 2007
Town of Southampton October 2003 - October 2004
Rainbow Media Holdings, Inc. February 2000 - October 2003
Skills
Financial Analysis, Business Development, Software Installation, Start-ups, Internal Controls, Auditing, Leadership, Employee Benefits, Mergers, Strategic Planning, Accounting, Project Management, Budgets, IT Operations, General Ledger, Management, Strategy, Financial Reporting, Managerial Finance, Corporate Finance, Financial Modeling, Cross-functional Team..., ERP, Cost Accounting, Consolidation, Process Improvement, Enterprise Software, Analysis, Executive Management, Business Process, Internal Audit, Mergers & Acquisitions
Education
Dowling College 2001 — 2003
MBA, Corporate Finance
Dowling College 1996 — 1998
BBA, Accounting
Guided Delivery Systems, Inc. 2005 - Present
Coalescent Surgical 1998 - 2005
Medtronic- AneuRx January 1998 - September 1998
ACS Guidant March 1996 - 1997
Skills
Catheters, Medical Devices, Specialized in Nitinol..., R&D, coils wiring, Catheter shaping., Bench testing., Built all typy..., Design and Prototype..., Stents, Design Control, Manufacturing, Product Development, Biomedical Engineering, ISO 13485, CAPA, Design of Experiments, ISO 14971, Quality System, Validation, V&V
Education
Mission College 1993 — 1994
Guided Delivery Systems, Inc. January 2015 - Present
Abbott Vascular Structural Heart (formerly Evalve, Inc.) August 2012 - January 2015
Abbott Vascular Structural Heart (formerly Evalve, Inc.) February 2011 - July 2012
Abbott Vascular Structural Heart (formerly Evalve, Inc.) July 2010 - January 2011
Evalve, Inc. July 2009 - June 2010
Skills
Clinical Trials, Clinical Research, Medical Devices, EDC, FDA, GCP, CTMS, Clinical Development, Clinical Data Management, Validation, Biotechnology, GMP, ICH-GCP, Vascular, Cardiology, CAPA, Clinical Monitoring, Lifesciences, ISO 13485, Biomedical Engineering, Design Control, PMA, Clinical Research..., Interventional..., Protocol, 21 CFR Part 11, Regulatory Submissions, Regulatory Affairs, Quality Assurance, Pharmaceutical Industry, CRO, Safety Narrative Writing
Education
Santa Clara University
Marriage Family Child Counseling
The Ohio State University
Bachelor of Science (B.S.), Medical Illustration
Vention Medical, Inc. January 2013 - Present
Guided Delivery Systems, Inc. August 2011 - January 2013
BioCardia September 2009 - August 2011
Aptus Endosystems, Inc. November 2003 - August 2009
Bacchus Vascular September 2001 - November 2003
Waterfall Co., Inc. October 2000 - September 2001
Salient Interventional Systems, Inc. August 1999 - October 2000
Medtronic Vascular (AneuRx) December 1998 - August 1999
St. Jude Medical (Ventritex) April 1990 - November 1998
Advanced Cardiovascular Systems March 1989 - April 1990
Skills
FDA, Design Control, Medical Devices, ISO 13485, ISO 14971, 21 CFR, 21 CFR Part 11, Biocompatibility, Biomedical Engineering, Biotechnology, CAPA, CE marking, CQA, Catheters, Change Control, Commercialization, Cross-functional Team..., Design for Manufacturing, Design of Experiments, FDA GMP, FMEA, GMP, ISO, Injection Molding, Leadership, Lean Manufacturing, Manufacturing, Manufacturing..., Medical Device Directive, Minitab, PMA, Product Development, Quality Assurance, Quality Auditing, Quality Control, Quality Management, Quality System, R, Regulatory Affairs, Regulatory Submissions, Root Cause Analysis, SPC, Start-ups, Sterilization, Supplier Quality, V, Validation
Education
Illinois Institute of Technology 1980 — 1984
BS, Mechanical Engineering
Thomson Reuters May 2013 - Present
Universal McCann June 2012 - November 2012
McCann Erickson June 2011 - August 2011
CONGRESSMAN JOE SESTAK CAMPAIGN August 2010 - November 2010
Kenneth Cole Productions June 2010 - August 2010
F&M Floyd Institute Center for Option Research September 2009 - June 2010
Arstasis 2010 - 2010
Guided Delivery Systems, Inc. 2010 - 2010
AISH Enterprise Internship June 2009 - July 2009
Quinnipiac University Polling Institute September 2007 - December 2008
Skills
Social Media, Public Relations, Advertising, Social Media Marketing, Marketing Strategy, Sales, Account Management, Microsoft Office, Promotions, Product Marketing, Community Outreach, Email Marketing, Marketing Communications, Digital Marketing, Social Networking, Blogging, Budgets, Market Research, Analytical Skills, Creative Problem Solving, Relationship Management, Corporate Communications, Corporate Sponsorships, Integrated Marketing, Sponsorship Activation, Sponsorship Management, Event Planning, Corporate Events, Special Events, Marketing, Leadership, Strategy, Management, Microsoft Excel, Sponsorship, Competitive Analysis, Online Advertising, Digital Media
Education
Franklin & Marshall College 2009 — 2012
Bachelor of Arts (B.A.), Government and Public Policy, 3.5
Quinnipiac University - School of Business 2007 — 2009
Small Business Management and Entrepreneurship
Endologix Inc January 2015 - Present
Endologix Inc April 2013 - Present
Guided Delivery Systems, Inc. April 2012 - April 2013
Medtronic Vascular November 2011 - March 2012
Medtronic Vascular January 2011 - November 2011
Advanced Medical Analysis, LLC September 2010 - December 2010
Institute of Health Promotion and Disease Prevention Research (IPR) August 2008 - August 2010
USC Norris Comprehensive Cancer Center March 2008 - July 2008
Department of Clinical Pharmacology, K.E.M. Hospital August 2006 - October 2007
St George Hospital September 2005 - July 2006
Skills
Clinical Research, Orthopedic, Medical Devices, R&D, Biotechnology, Medicine, Clinical Trials, Drug Development, FDA, GCP, Healthcare, Clinical Development, Biomedical Engineering, Cardiology, Neurology, Public Health, Biostatistics, Epidemiology
Education
Keck School of Medicine of the University of Southern California 2008 — 2010
MPH, Epidemiology/Biostatistics
Maharashtra University of Health Sciences 1999 — 2005
M.B.B.S., Medicine
Jai Hind College 1997 — 1999
H.S.C.
St. Josephs High School
S.S.C.
UCSF August 2015 - Present
Threshold Pharmaceuticals February 2014 - April 2015
Guided Delivery Systems, Inc. April 2013 - January 2014
Affymax, Inc. August 2012 - March 2013
ProTrials Research September 2011 - November 2012
Affymax October 2008 - September 2011
Ventus Medical May 2008 - September 2008
FoxHollow Division, Ev3, Inc. November 2007 - May 2008
FoxHollow Division, Ev3, Inc. January 2007 - October 2007
Sara L. Colby, MD & Assoc. April 2004 - December 2006
Skills
Clinical Trials, Clinical Research, Clinical Development, Dermatology, CRO, CTMS, EDC, FDA, GCP, Management, Medical Devices, Medicine, Surgery, Clinical Monitoring, Oncology
Education
Brandman University, Part of the Chapman University System 2013 — 2018
Bachelor’s Degree
University of California, Santa Cruz 2007 — 2009
Clinical Research
De Anza College 2004 — 2009
AA, Liberal Arts, Social & Behavorial Sciences Emphasis
Cordis, Johnson & Johnson 2013 - Present
AngioScore 2011 - 2013
Guided Delivery Systems, Inc. 2010 - 2011
Guided Delivery Systems, Inc. 2008 - 2010
Abbott Vascular Devices 2006 - 2008
Abbott Vascular Devices 2004 - 2006
Dade Behring June 2004 - September 2004
Dade Behring February 2003 - September 2003
Anawah, Inc. 2000 - 2003
Skills
Medical Devices, R&D, Catheters, Design Control, Biocompatibility, Biomaterials, Drug Eluting Stents, Design of Experiments, Test Method Development, Failure Analysis, Solidworks, AutoCAD, Engineering Statistics, Rapid Prototyping, GDP, FDA GMP, Cross-functional Team..., C++, PCR, Gel Electrophoresis, FDA, GMP, Biomedical Engineering
Education
California Polytechnic State University-San Luis Obispo 2003 — 2005
Masters of Science, Biomedical Engineering
University of California, Davis 1998 — 2002
Bachelors of Science, Biosystems Engineering - Specializing in Biomedical Engineering and Biotechnology
Mission San Jose High School
Abbott Diabetes Care February 2012 - Present
Guided Delivery Systems, Inc. December 2008 - February 2012
Consumer Genetics January 2006 - December 2008
Skills
Laboratory, Genetics, PCR, Biotechnology, DNA, Medical Devices, Molecular Biology, Clinical Research, Clinical Trials, Clinical Monitoring, CCRA
Education
Penn State University 2013 — 2015
Master of Business Administration (MBA)
Association of Clinical Research Professionals
Certified Clinical Research Associate (CCRA) through Association of Clinical Research Professionals
University of California, Davis 2004 — 2006
B.S., Nutrition Biochemistry
Guided Delivery Systems, Inc. December 2011 - Present
Paracor Medical, Inc. May 2010 - April 2011
Acorn Cardiovascular November 2009 - May 2010
Paracor Medical, Inc 2003 - 2009
Appriva/EV3 2000 - 2003
Paracor Surgical 1999 - 2000
Prograft Medical/ W.L. Gore & Associates 1995 - 1999
Oximetrix/Abbott Laboratories 1985 - 1995
Drivetec 1983 - 1985
Shugart Associates 1980 - 1983
Skills
Medical Devices, FDA, Design Control, Clinical Engineering, Design of Experiments, Manufacturing, ISO 13485, R&D, Medical Imaging, Quality System, ISO 14971, Biomedical Engineering, Commercialization, Validation, CAPA
Education
San Jose State University
BSME, Design
Guided Delivery Systems, Inc. June 2008 - Present
FoxHollow Technologies December 2003 - February 2006
Guidant Corporation November 1996 - October 2003
Skills
Fabricated various..., Helix machine,Parts..., Microscope experience..., Assemble various..., FDA, Manufacturing, ISO 13485, R&D, Medical Devices
Education
City College of San Francisco 1984 — 1987
General Studies
John Adams Community College 1980 — 1984
General Education
BioVentrix, inc January 2013 - Present
Guided Delivery Systems, Inc. May 2008 - December 2012
Education
University of California, Santa Barbara 1976 — 1979
Bachelor's degree, Pharmacology