Emphasys Medical
Industry: Company
DescriptionFounded: 2000
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Emphasys Medical Employees
Employee
Years
Job
Industry
David Tholfsen David Tholfsen's Emphasys Medical Experience January 2001 - January 2004
Job R&D Engineer at Twelve
Industry Medical Devices
Experience
Twelve July 2013 - Present
InterVene November 2012 - June 2013
QLT March 2009 - July 2012
Ample Medical, Inc 2004 - 2008
Emphasys Medical January 2001 - January 2004
ArthroCare Corporation June 1995 - January 1997
Devices for Vascular Intervention 1989 - 1993
Skills
Medical Devices, R&D, Solidworks, Catheters, Delivery Systems, Mold Design, Machining
Education
Bennington College 1976 — 1980
BA, Sculpture and Ceramics
Twelve July 2013 - Present
InterVene November 2012 - June 2013
QLT March 2009 - July 2012
Ample Medical, Inc 2004 - 2008
Emphasys Medical January 2001 - January 2004
ArthroCare Corporation June 1995 - January 1997
Devices for Vascular Intervention 1989 - 1993
Skills
Medical Devices, R&D, Solidworks, Catheters, Delivery Systems, Mold Design, Machining
Education
Bennington College 1976 — 1980
BA, Sculpture and Ceramics
Albert Boniske Albert Boniske's Emphasys Medical Experience September 2006 - February 2007
Job Regulatory Consultant at Boniske Strategies, LLC
Industry Medical Devices
Experience
Boniske Strategies, LLC August 2015 - Present
AliveCor, Inc. February 2014 - August 2015
PQ Bypass January 2013 - February 2014
Avinger Inc. (Acquired Sawooth Labs) May 2012 - December 2012
Experien Group, LLC March 2010 - May 2012
Experien Group, LLC March 2007 - March 2010
Emphasys Medical September 2006 - February 2007
Posit Science January 2006 - June 2006
Skills
Regulatory Affairs, Statistics, Microsoft Office, Clinical Research, Strategic Planning, Medical Devices, FDA, Regulatory Submissions, PMA, IDE, ISO 14971, Healthcare, Clinical Trials, Design Control, Hardware Diagnostics, ISO 13485, Quality Assurance, CAPA, GMP, Quality System, CE marking, Clinical Study Design, V&V, Clinical Development
Education
University of California, Berkeley 2001 — 2005
Molecular and Cell Biology with an emphasis in Neurobiology
Boniske Strategies, LLC August 2015 - Present
AliveCor, Inc. February 2014 - August 2015
PQ Bypass January 2013 - February 2014
Avinger Inc. (Acquired Sawooth Labs) May 2012 - December 2012
Experien Group, LLC March 2010 - May 2012
Experien Group, LLC March 2007 - March 2010
Emphasys Medical September 2006 - February 2007
Posit Science January 2006 - June 2006
Skills
Regulatory Affairs, Statistics, Microsoft Office, Clinical Research, Strategic Planning, Medical Devices, FDA, Regulatory Submissions, PMA, IDE, ISO 14971, Healthcare, Clinical Trials, Design Control, Hardware Diagnostics, ISO 13485, Quality Assurance, CAPA, GMP, Quality System, CE marking, Clinical Study Design, V&V, Clinical Development
Education
University of California, Berkeley 2001 — 2005
Molecular and Cell Biology with an emphasis in Neurobiology
Lisa Simmonds's Emphasys Medical Experience January 2008 - February 2009
Job Medical Device Supply Chain Management
Industry Medical Devices
Experience
Pulmonx November 2009 - Present
Pulmonx, Inc. March 2009 - November 2009
Maquet Cardiovascular March 2009 - July 2009
Emphasys Medical January 2008 - February 2009
Boston Scientific - Cardiac Surgery February 2002 - October 2007
Guidant - Cardiac Surgery and Endovascular Solutions 1999 - 2002
Guidant 1992 - 1999
Skills
Supply Chain Management, Procurement, Inventory Control, Supply Chain, ERP, MRP, Medical Devices, FDA, Quality System, QAD, Process Improvement, Cross-functional Team..., Project Management, GMP, Start-ups, Product Launch, Validation, Leadership, Quality Assurance, Integration, Materials Management, Strategy, SAP, Strategic Sourcing, Business Process, Management, Supply Management, Manufacturing
Education
Santa Clara University 1991 — 1995
MBA
University of California, Davis
BA
Pulmonx November 2009 - Present
Pulmonx, Inc. March 2009 - November 2009
Maquet Cardiovascular March 2009 - July 2009
Emphasys Medical January 2008 - February 2009
Boston Scientific - Cardiac Surgery February 2002 - October 2007
Guidant - Cardiac Surgery and Endovascular Solutions 1999 - 2002
Guidant 1992 - 1999
Skills
Supply Chain Management, Procurement, Inventory Control, Supply Chain, ERP, MRP, Medical Devices, FDA, Quality System, QAD, Process Improvement, Cross-functional Team..., Project Management, GMP, Start-ups, Product Launch, Validation, Leadership, Quality Assurance, Integration, Materials Management, Strategy, SAP, Strategic Sourcing, Business Process, Management, Supply Management, Manufacturing
Education
Santa Clara University 1991 — 1995
MBA
University of California, Davis
BA
Lawandra Adams Lawandra Adams's Emphasys Medical Experience 2003 - 2006
Job Senior Buyer at Theravance Inc.
Industry Medical Devices
Experience
Theravance Biopharma, Inc. June 2013 - Present
Cytokinetics, Bio-rad Labs, ABC Concise and Vasonova- Contracted Positions January 2012 - January 2014
Stryker Endoscopy June 2011 - September 2011
Abbott Diabetes Care December 2010 - May 2011
El Camino Hospital April 2009 - December 2010
XTENT, Inc. January 2007 - July 2008
Emphasys Medical 2003 - 2006
UCSF Stanford 1998 - 1999
Skills
Medical Devices, Quality System, GMP, ISO 13485, FDA, Cross-functional Team..., ISO, CAPA, Quality Assurance, Lean Manufacturing, R&D, Design Control, Biotechnology, Manufacturing, Validation
Education
University of Phoenix 1998 — 2001
Bachelors of Science, Business Management
Theravance Biopharma, Inc. June 2013 - Present
Cytokinetics, Bio-rad Labs, ABC Concise and Vasonova- Contracted Positions January 2012 - January 2014
Stryker Endoscopy June 2011 - September 2011
Abbott Diabetes Care December 2010 - May 2011
El Camino Hospital April 2009 - December 2010
XTENT, Inc. January 2007 - July 2008
Emphasys Medical 2003 - 2006
UCSF Stanford 1998 - 1999
Skills
Medical Devices, Quality System, GMP, ISO 13485, FDA, Cross-functional Team..., ISO, CAPA, Quality Assurance, Lean Manufacturing, R&D, Design Control, Biotechnology, Manufacturing, Validation
Education
University of Phoenix 1998 — 2001
Bachelors of Science, Business Management
Mariana Alvarado Hernandez Mariana Alvarado Hernandez's Emphasys Medical Experience October 2007 - August 2008
Job Clinical Trial Manager at Jaguar Animal Health
Industry Pharmaceuticals
Experience
Jaguar Animal Health September 2015 - Present
XOMA July 2014 - September 2015
Biotie Therapies, Inc. October 2011 - July 2014
PRC CLINICAL March 2011 - October 2011
MAP Pharmaceuticals August 2008 - December 2010
Emphasys Medical October 2007 - August 2008
Radiant Medical December 2006 - July 2007
Abbott Vascular (Abbott Vascular Devices) 2002 - 2006
Skills
Clinical Trials, FDA, Medical Devices, Regulatory Affairs, GCP, Clinical Research, CRO, CTMS, Regulatory Submissions, Protocol, Pharmaceutical Industry, Biotechnology, Clinical Development, Oncology, Clinical Data Management, Drug Development, ICH-GCP
Education
Santa Clara University 1990 — 1994
Jaguar Animal Health September 2015 - Present
XOMA July 2014 - September 2015
Biotie Therapies, Inc. October 2011 - July 2014
PRC CLINICAL March 2011 - October 2011
MAP Pharmaceuticals August 2008 - December 2010
Emphasys Medical October 2007 - August 2008
Radiant Medical December 2006 - July 2007
Abbott Vascular (Abbott Vascular Devices) 2002 - 2006
Skills
Clinical Trials, FDA, Medical Devices, Regulatory Affairs, GCP, Clinical Research, CRO, CTMS, Regulatory Submissions, Protocol, Pharmaceutical Industry, Biotechnology, Clinical Development, Oncology, Clinical Data Management, Drug Development, ICH-GCP
Education
Santa Clara University 1990 — 1994
Vinh La's Emphasys Medical Experience November 2006 - July 2007
Job Clinical Research Associate at Portola Pharmaceuticals
Industry Biotechnology
Experience
Portola Pharmaceuticals October 2012 - Present
JANSSEN Alzheimer Immunotherapy September 2010 - October 2012
JANSSEN Alzheimer Immunotherapy 2010 - 2012
NeoTract July 2010 - August 2010
Emphasys Medical November 2006 - July 2007
ICON plc September 2005 - March 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Electronic Data..., GCP, ICH guidelines, FDA GMP, Datafax, Clinical Trials, Clinical Operations, Trial Master File, CTMS, Oracle Clinical, Document Management, ICH-GCP, eTMF, IVRS, Medical Affairs
Education
San Francisco State University 2010 — 2012
Clinical Trails Design and Management Certificate
San Francisco State University
Bachelor of Science (BS), Physiology, General
Portola Pharmaceuticals October 2012 - Present
JANSSEN Alzheimer Immunotherapy September 2010 - October 2012
JANSSEN Alzheimer Immunotherapy 2010 - 2012
NeoTract July 2010 - August 2010
Emphasys Medical November 2006 - July 2007
ICON plc September 2005 - March 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Electronic Data..., GCP, ICH guidelines, FDA GMP, Datafax, Clinical Trials, Clinical Operations, Trial Master File, CTMS, Oracle Clinical, Document Management, ICH-GCP, eTMF, IVRS, Medical Affairs
Education
San Francisco State University 2010 — 2012
Clinical Trails Design and Management Certificate
San Francisco State University
Bachelor of Science (BS), Physiology, General
Ron Dailey Ron Dailey's Emphasys Medical Experience April 2004 - October 2006
Job Marketing Representative at Marley Drug
Industry Medical Devices
Experience
Marley Drug April 2013 - Present
Vendition Partners June 2012 - May 2014
Physician Consulting, Inc. 2012 - 2014
National Sleep Therapy October 2010 - May 2012
Corporate Facility Services December 2008 - October 2010
superDimension October 2006 - May 2008
Emphasys medical April 2004 - October 2006
Abbott Laboratories March 1974 - April 2004
Skills
Surgery, Hospitals, Anesthesia, ICU, Medical Devices, Sales Management, Pulmonology, Healthcare, Operating Room, Cardiology, Management, Home Care, Managed Care, Medicine, Capital Equipment, Selling, Leadership, Healthcare Management, Start-ups, Pain Management, Oncology, Physicians, Surgeons, Clinical Research, Neurology, Orthopedic, Sales Management..., Critical Care, Sales
Education
North Carolina State University
BA, English, Natural Sciences
Marley Drug April 2013 - Present
Vendition Partners June 2012 - May 2014
Physician Consulting, Inc. 2012 - 2014
National Sleep Therapy October 2010 - May 2012
Corporate Facility Services December 2008 - October 2010
superDimension October 2006 - May 2008
Emphasys medical April 2004 - October 2006
Abbott Laboratories March 1974 - April 2004
Skills
Surgery, Hospitals, Anesthesia, ICU, Medical Devices, Sales Management, Pulmonology, Healthcare, Operating Room, Cardiology, Management, Home Care, Managed Care, Medicine, Capital Equipment, Selling, Leadership, Healthcare Management, Start-ups, Pain Management, Oncology, Physicians, Surgeons, Clinical Research, Neurology, Orthopedic, Sales Management..., Critical Care, Sales
Education
North Carolina State University
BA, English, Natural Sciences
Tad Finkler Tad Finkler's Emphasys Medical Experience June 2004 - August 2004
Job
Industry Mechanical or Industrial Engineering
Experience
Finkler Design January 2008 - Present
Open Energy Corporation 2006 - 2008
Mobius Technologies August 2005 - April 2006
Emphasys Medical June 2004 - August 2004
Genemachines January 2000 - January 2002
Skills
Robotics, Labview, R&D, Product Design, Mechanical Engineering, Mechatronics, Mechanical Analysis, Mechanism Design, Design for Manufacturing, Machine Design, Mechanical Systems, Engineering, Solidworks, Automation, Manufacturing, Product Development, CAD
Education
Stanford University 2003 — 2005
M.S.
Stanford University 1997 — 1999
B.S.
Westmont College 1994 — 1997
B.A.
Finkler Design January 2008 - Present
Open Energy Corporation 2006 - 2008
Mobius Technologies August 2005 - April 2006
Emphasys Medical June 2004 - August 2004
Genemachines January 2000 - January 2002
Skills
Robotics, Labview, R&D, Product Design, Mechanical Engineering, Mechatronics, Mechanical Analysis, Mechanism Design, Design for Manufacturing, Machine Design, Mechanical Systems, Engineering, Solidworks, Automation, Manufacturing, Product Development, CAD
Education
Stanford University 2003 — 2005
M.S.
Stanford University 1997 — 1999
B.S.
Westmont College 1994 — 1997
B.A.
Rubyrose Kozuma's Emphasys Medical Experience November 2008 - January 2009
Job Customer Service Manager at Roxwood Medical
Industry Medical Devices
Experience
Roxwood Medical, Inc July 2015 - Present
Avinger Inc. February 2014 - July 2015
Avinger Inc. September 2011 - February 2014
AvalonBay Communities March 2009 - September 2011
Emphasys Medical November 2008 - January 2009
JAI A/S April 2006 - November 2008
Sprint December 2002 - December 2005
Sprint March 2002 - December 2002
Skills
Sales Operations, Customer Service, Project Management, Medical Devices, Account Management, Sales, Forecasting, Product Development, Direct Sales, Start-ups, Solution Selling, Salesforce.com, Product Management, Sales Process, Microsoft Office, Product Launch, Quality System, Manufacturing, Selling, SAP, Operations Management
Education
San Jose State University
BS, Business Administration (MIS)
Roxwood Medical, Inc July 2015 - Present
Avinger Inc. February 2014 - July 2015
Avinger Inc. September 2011 - February 2014
AvalonBay Communities March 2009 - September 2011
Emphasys Medical November 2008 - January 2009
JAI A/S April 2006 - November 2008
Sprint December 2002 - December 2005
Sprint March 2002 - December 2002
Skills
Sales Operations, Customer Service, Project Management, Medical Devices, Account Management, Sales, Forecasting, Product Development, Direct Sales, Start-ups, Solution Selling, Salesforce.com, Product Management, Sales Process, Microsoft Office, Product Launch, Quality System, Manufacturing, Selling, SAP, Operations Management
Education
San Jose State University
BS, Business Administration (MIS)
Brett Hale's Emphasys Medical Experience July 2007 - December 2008
Job CFO at CardioKinetix
Industry Medical Devices
Experience
CardioKinetix Inc. February 2013 - Present
Vibrynt, Inc April 2012 - February 2013
Concentric Medical February 2010 - April 2012
Concentric Medical February 2009 - January 2010
Emphasys Medical July 2007 - December 2008
Boston Scientific / Cardiac Surgery September 2006 - June 2007
Guidant Cardiac Surgery April 2005 - September 2006
Guidant Corporation (Santa Clara) August 2003 - April 2005
Guidant Corporation - Vascular Intervention Division June 2002 - July 2003
PriceWaterhouseCoopers LLP July 1995 - May 2000
Education
Indiana University - Kelley School of Business 2000 — 2002
MBA, Finance
Indiana University - Kelley School of Business 1991 — 1995
BS, Accounting
CardioKinetix Inc. February 2013 - Present
Vibrynt, Inc April 2012 - February 2013
Concentric Medical February 2010 - April 2012
Concentric Medical February 2009 - January 2010
Emphasys Medical July 2007 - December 2008
Boston Scientific / Cardiac Surgery September 2006 - June 2007
Guidant Cardiac Surgery April 2005 - September 2006
Guidant Corporation (Santa Clara) August 2003 - April 2005
Guidant Corporation - Vascular Intervention Division June 2002 - July 2003
PriceWaterhouseCoopers LLP July 1995 - May 2000
Education
Indiana University - Kelley School of Business 2000 — 2002
MBA, Finance
Indiana University - Kelley School of Business 1991 — 1995
BS, Accounting
Jennifer Hebert's Emphasys Medical Experience January 2003 - December 2004
Job President & Principal Consultant, ClinAssist, LLC
Industry Medical Devices
Experience
ClinAssist, LLC December 2004 - Present
Emphasys Medical January 2003 - December 2004
Boston Scientific March 2002 - January 2003
Satiety, Inc. August 2001 - February 2002
PharmaSonics,Inc December 1999 - August 2001
IsoStent, Inc. May 1996 - May 1999
Skills
Medical Devices, GCP, FDA, Clinical, Clinical Trials, Cardiology, Neurology, CRO, Clinical Development, Regulatory Affairs, Data Management, Quality Assurance, Clinical Research, Strategic Planning, Research, Team Building, Customer Relations, Process Improvement, Contract Negotiation, Program Management, Documentation, Problem Solving, Compliance, Clinical Trial..., Vendor Management, Cross-functional Team..., EDC, Mentoring, Healthcare, Quality System, Clinical Operations
Education
Notre Dame de Namur University 2000 — 2005
ClinAssist, LLC December 2004 - Present
Emphasys Medical January 2003 - December 2004
Boston Scientific March 2002 - January 2003
Satiety, Inc. August 2001 - February 2002
PharmaSonics,Inc December 1999 - August 2001
IsoStent, Inc. May 1996 - May 1999
Skills
Medical Devices, GCP, FDA, Clinical, Clinical Trials, Cardiology, Neurology, CRO, Clinical Development, Regulatory Affairs, Data Management, Quality Assurance, Clinical Research, Strategic Planning, Research, Team Building, Customer Relations, Process Improvement, Contract Negotiation, Program Management, Documentation, Problem Solving, Compliance, Clinical Trial..., Vendor Management, Cross-functional Team..., EDC, Mentoring, Healthcare, Quality System, Clinical Operations
Education
Notre Dame de Namur University 2000 — 2005
Susan (Schaeffer) Hale's Emphasys Medical Experience 2004 - February 2009
Job Quality Assurance Consultant
Industry Medical Devices
Experience
Sole Proprietor 2011 - Present
Avinger, Inc August 2009 - December 2011
Emphasys Medical 2004 - February 2009
Abbott Vascular Devices 2002 - 2004
Abbott Laboratories 2001 - 2002
Abbott Laboratories 2000 - 2001
Abbott Laboratories 1999 - 2000
Skills
Quality Systems, FDA, ISO 13485, Quality Assurance, CAPA, Documentation, Product Development, Design Control, GMP, Biomedical Engineering, Document Management, Quality System, Validation, Product Launch, Software Documentation, R, Medical Devices, Biotechnology, V
Education
University of Notre Dame
BS, Chemical Engineering
University of Pennsylvania
MS, Biomedical Engineering
Sole Proprietor 2011 - Present
Avinger, Inc August 2009 - December 2011
Emphasys Medical 2004 - February 2009
Abbott Vascular Devices 2002 - 2004
Abbott Laboratories 2001 - 2002
Abbott Laboratories 2000 - 2001
Abbott Laboratories 1999 - 2000
Skills
Quality Systems, FDA, ISO 13485, Quality Assurance, CAPA, Documentation, Product Development, Design Control, GMP, Biomedical Engineering, Document Management, Quality System, Validation, Product Launch, Software Documentation, R, Medical Devices, Biotechnology, V
Education
University of Notre Dame
BS, Chemical Engineering
University of Pennsylvania
MS, Biomedical Engineering
Oksana Kozlova's Emphasys Medical Experience August 2006 - February 2009
Job
Industry Medical Devices
Experience
Direct Flow Medical®, Inc. October 2014 - Present
Independent Consultant October 2011 - October 2014
Medtronic - Ardian June 2010 - July 2011
Abbott Vascular, Structural Heart (Formerly Evalve, Inc) February 2009 - June 2010
Emphasys Medical August 2006 - February 2009
US Computer Software, Inc October 2002 - May 2006
INSTITUTE OF CYTOLOGY AND GENETICS , Russian Academy of Science, Novosibirsk, Russia August 1989 - January 2001
Skills
Life Sciences, Clinical Trials, Medical Devices, FDA, Biostatistics, SAS Base, SAS/GRAPH, SAS/STAT, SAS/SQL, SAS Macro, Clinical Programming, Clinical Data Management, MS Office Professional..., UNIX OS, Perl Script, JAVA, Visual C#, SAS, Microsoft Office, Java, Lifesciences, EDC, Clinical Research, Unix, Quality System, Quality Assurance, GMP, SAS programming, ISO 13485
Education
Research Institute of Physiology SB RAMS, Novosibirsk, Russia 1991 — 1994
Ph.D.
Novosibirsk State University (NSU) 1983 — 1989
MS
De Anza College
AA
Direct Flow Medical®, Inc. October 2014 - Present
Independent Consultant October 2011 - October 2014
Medtronic - Ardian June 2010 - July 2011
Abbott Vascular, Structural Heart (Formerly Evalve, Inc) February 2009 - June 2010
Emphasys Medical August 2006 - February 2009
US Computer Software, Inc October 2002 - May 2006
INSTITUTE OF CYTOLOGY AND GENETICS , Russian Academy of Science, Novosibirsk, Russia August 1989 - January 2001
Skills
Life Sciences, Clinical Trials, Medical Devices, FDA, Biostatistics, SAS Base, SAS/GRAPH, SAS/STAT, SAS/SQL, SAS Macro, Clinical Programming, Clinical Data Management, MS Office Professional..., UNIX OS, Perl Script, JAVA, Visual C#, SAS, Microsoft Office, Java, Lifesciences, EDC, Clinical Research, Unix, Quality System, Quality Assurance, GMP, SAS programming, ISO 13485
Education
Research Institute of Physiology SB RAMS, Novosibirsk, Russia 1991 — 1994
Ph.D.
Novosibirsk State University (NSU) 1983 — 1989
MS
De Anza College
AA
Chad Yolland's Emphasys Medical Experience January 2008 - February 2009
Job Sr. Manufacturing Engineer at Ceterix Orthopaedics
Industry Medical Devices
Experience
Ceterix Orthopaedics June 2013 - Present
PulmonX April 2010 - June 2013
Voyage Medical February 2010 - April 2010
Vibrynt September 2009 - February 2010
Emphasys Medical January 2008 - February 2009
Systron Donner Inertial July 2004 - January 2008
Skills
Design Control, CAPA, Design of Experiments, Manufacturing, ISO 13485, V&V, FDA, Quality System, ISO 14971, Medical Devices, Design for Manufacturing, Validation, Biomedical Engineering, Catheters, FMEA, R&D, Solidworks, CE marking, Injection Molding, Manufacturing..., SPC
Education
California Polytechnic State University-San Luis Obispo 1998 — 2003
BS, Industrial Engineering
Ceterix Orthopaedics June 2013 - Present
PulmonX April 2010 - June 2013
Voyage Medical February 2010 - April 2010
Vibrynt September 2009 - February 2010
Emphasys Medical January 2008 - February 2009
Systron Donner Inertial July 2004 - January 2008
Skills
Design Control, CAPA, Design of Experiments, Manufacturing, ISO 13485, V&V, FDA, Quality System, ISO 14971, Medical Devices, Design for Manufacturing, Validation, Biomedical Engineering, Catheters, FMEA, R&D, Solidworks, CE marking, Injection Molding, Manufacturing..., SPC
Education
California Polytechnic State University-San Luis Obispo 1998 — 2003
BS, Industrial Engineering
Kris Nethercut-Emerson's Emphasys Medical Experience August 2001 - August 2003
Job
Industry Hospital & Health Care
Experience
SageHMS May 2005 - Present
SterilMed September 2003 - January 2005
Emphasys Medical August 2001 - August 2003
American Medical Systems August 1999 - April 2001
RedLine 1992 - 1997
Skills
Medical Devices, Capital Equipment, Training, Urology, Product Launch, Operating Room, Quality System, Sales Management, Surgeons, Sales Operations, Account Management, Cardiology, FDA, Disposables, Cross-functional Team..., Healthcare, Sales Force Development, Market Development, Sales Effectiveness, Hospitals, Surgery, Orthopedic, OB/GYN, Clinical Research, Software Documentation, Leadership
Education
College of St. Catherine 1983 — 1985
RN, Nursing
University of Minnesota-Twin Cities 1979 — 1983
BA, Psychology
SageHMS May 2005 - Present
SterilMed September 2003 - January 2005
Emphasys Medical August 2001 - August 2003
American Medical Systems August 1999 - April 2001
RedLine 1992 - 1997
Skills
Medical Devices, Capital Equipment, Training, Urology, Product Launch, Operating Room, Quality System, Sales Management, Surgeons, Sales Operations, Account Management, Cardiology, FDA, Disposables, Cross-functional Team..., Healthcare, Sales Force Development, Market Development, Sales Effectiveness, Hospitals, Surgery, Orthopedic, OB/GYN, Clinical Research, Software Documentation, Leadership
Education
College of St. Catherine 1983 — 1985
RN, Nursing
University of Minnesota-Twin Cities 1979 — 1983
BA, Psychology
James Wirzman's Emphasys Medical Experience 2007 - 2008
Job Clinician at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health Clinical December 2012 - Present
Pharmanet-i3 November 2009 - December 2012
Premier Research Group 2008 - 2009
Emphasys Medical 2007 - 2008
Johnson & Johnson 2004 - 2006
Covance 2003 - 2004
Novartis 1997 - 2003
Cordis 1991 - 1997
Johnson & Johnson 1984 - 1991
Beth Israel Medical Center 1983 - 1983
Skills
CTMS, Clinical Research, Pharmaceutical Industry, GCP, Clinical Development, CRO, Clinical Monitoring
Education
USPHS Physician Assistant Training Program 1979 — 1981
PA, Medicine, Surgery
Rutgers University-New Brunswick 1975 — 1979
B.A., Biology, Psychology
inVentiv Health Clinical December 2012 - Present
Pharmanet-i3 November 2009 - December 2012
Premier Research Group 2008 - 2009
Emphasys Medical 2007 - 2008
Johnson & Johnson 2004 - 2006
Covance 2003 - 2004
Novartis 1997 - 2003
Cordis 1991 - 1997
Johnson & Johnson 1984 - 1991
Beth Israel Medical Center 1983 - 1983
Skills
CTMS, Clinical Research, Pharmaceutical Industry, GCP, Clinical Development, CRO, Clinical Monitoring
Education
USPHS Physician Assistant Training Program 1979 — 1981
PA, Medicine, Surgery
Rutgers University-New Brunswick 1975 — 1979
B.A., Biology, Psychology
Steve Wallace, P.E.'s Emphasys Medical Experience August 2002 - April 2009
Job Director of Operations
Industry Medical Devices
Experience
PulmonX April 2009 - Present
Emphasys Medical August 2002 - April 2009
Skills
ISO 13485, Design Control, Medical Devices, FDA, CAPA, Quality System, V&V, Design for Manufacturing, Design of Experiments, R&D, Manufacturing, Validation, Solidworks, Product Development, Cross-functional Team..., Manufacturing..., Product Launch, Lean Manufacturing, FMEA, Biomedical Engineering, Start-ups
Education
California Polytechnic State University-San Luis Obispo 1995 — 1998
BS, Mechanical Engineering
PulmonX April 2009 - Present
Emphasys Medical August 2002 - April 2009
Skills
ISO 13485, Design Control, Medical Devices, FDA, CAPA, Quality System, V&V, Design for Manufacturing, Design of Experiments, R&D, Manufacturing, Validation, Solidworks, Product Development, Cross-functional Team..., Manufacturing..., Product Launch, Lean Manufacturing, FMEA, Biomedical Engineering, Start-ups
Education
California Polytechnic State University-San Luis Obispo 1995 — 1998
BS, Mechanical Engineering
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY