Aerogen Company
Industry: Company
DescriptionHeadquarters: Galway, Republic of Ireland Founded: 1997
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Aerogen Employees
James B. Fink, LLC November 2008 - Present
Georgia State University March 2009 - Present
Rush University Medical Center July 2011 - Present
Dance Biopharm January 2010 - Present
Aerogen January 2009 - Present
Nektar Therapeutics April 2000 - October 2008
Aerogen 2001 - 2005
Hines VA Medical Center June 1993 - April 2000
Loyola University Chicago May 1993 - April 2000
University of California, San Francisco June 1979 - January 1993
Skills
Biotechnology, Drug Delivery, Medical Devices, Pharmaceutical Industry, Clinical Research, Clinical Trials, R&D, Clinical Development, FDA, GMP, Technology Transfer, GLP, Drug Development, Pharmacology, Healthcare, Respiratory Care, Medicine, Hospitals, Regulatory Affairs, Respiratory Therapy, Critical Care, Product Development, Sop, Cardiology, Informatics, Biochemistry, ISO 13485, Vaccines, Regulatory Submissions, Drug Discovery, CRO, Biomedical Engineering, Business Development, Pediatrics, ICU, Patient Safety, Pharmaceutics, Medical Education, Patient Education, In Vitro, Diabetes, Commercialization, GCP, Toxicology, Biopharmaceuticals, Hardware Diagnostics, Protocol, Neuroscience, Chromatography
Education
Bradford College 2005 — 2007
Ph.D., Pharmaceutics
Florida International University 1977 — 1979
MS, Adult Education
St. Petersburg Junior College 1973 — 1975
AS, Respiratory Therapy
University of South Florida 1967 — 1971
BA, Philosophy/Psychology
Gilead Sciences April 2015 - Present
QuinStreet March 2010 - April 2015
SiRF Technology June 2004 - May 2010
Aerogen April 1998 - May 2004
Education
CEP Institute, Santa Clara University 2003 — 2005
Certified Equity Professional (CEP) Designee
San Jose State University 1988 — 1992
Bachelor of Arts (B.A.), English Language and Literature, General
Corcept Therapeutics 2015 - Present
InterMune 2012 - 2015
Alexza Pharmaceuticals 2008 - 2012
Anthera Pharmaceuticals 2005 - 2008
Aerogen 1997 - 2005
Heartport 1995 - 1997
Stanford University School of Medicine 1993 - 1995
Harvard University Health Services 1990 - 1993
Skills
Clinical Development, Clinical Trials, Drug Development, Medical Devices, FDA, Pulmonary Disease, Aerosol Science, Lifesciences, Pulmonology, Pharmaceutical Industry, Biotechnology, Internal Medicine, Asthma, Psychiatry, NDA, Hematology, Medicine, Clinical Research, Infectious Diseases, Biopharmaceuticals
Education
Massachusetts General Hospital 1989 — 1992
Fellowship in Pulmonary & Critical Care Medicine
BI / Deaconess Medical Center 1986 — 1989
Residency in Internal Medicine
Stanford University School of Medicine 1982 — 1986
MD, Medicine
Harvard University 1978 — 1982
AB, Biology
Alexza Pharmaceuticals March 2014 - Present
Gilead Sciences October 2012 - February 2014
Abbott Vascular (formerly Guidant) June 2002 - June 2012
Aerogen June 2000 - June 2002
Skills
HPLC, UPLC, UV/Vis, Karl Fisher, LIMS, Sop, Deviations, CAPA, GPC, OOS, Leadership Trainer, Quality Control, FDA, GMP, GLP, GC-FID, Microsoft Excel, Microsoft Word, PowerPoint, Experienced Trainer, IV, Microsoft Office
Education
UC Santa Cruz
Bachelor of Science (BS), Chemistry
Corium International September 2012 - Present
Corium International September 2012 - Present
Codexis January 2006 - June 2009
Aerogen August 2002 - October 2005
Aerogen April 2002 - August 2002
Johnson & Johnson May 2001 - March 2002
ALZA Corporation June 1994 - May 2001
Skills
Licensing, Pharmaceutical Industry, Biotechnology, Equities, SEC filings, Medical Devices, Strategic Financial..., Lifesciences, Technology Transfer, FDA, Venture Capital, Cross-functional Team..., Mergers, Commercialization, Due Diligence, Financial Structuring, R&D, Corporate Development, Start-ups
Education
Stanford University Graduate School of Business 1991 — 1993
MBA, Finance, Private Equity, Entrepreneurship
United States Naval Academy 1979 — 1983
BSEE, Electrical Engineering, Aviation
Aerogen September 2011 - Present
CareFusion July 2009 - December 2010
Westmed 2010 - 2010
Cardinal Health April 2002 - June 2009
Skills
Capital Equipment, Healthcare, Cardiology, Medical Devices, Surgery, Hospitals, Disposables, Operating Room, Market Development, Product Launch, Surgeons, Medical Sales, Durable Medical..., Sales Operations, Selling, Cross-functional Team..., Medicine, Surgical Instruments, Sales Management, Capital Equipment Sales, Critical Care, Sales, Home Care, Orthopedic, Sales Force Development, Healthcare Industry, Vascular
Education
Loyola University New Orleans
Bachelors in Business Administration
Better Homes & Gardens Tri-Valley Realty February 2004 - Present
Hendrick Automotive Group June 2002 - February 2004
Covidien August 2001 - October 2002
Oridion Medical September 1999 - May 2001
AeroGen February 1997 - August 1999
Baxter Healthcare June 1995 - February 1997
Bird Medical Products February 1994 - June 1995
Baxter Healthcare December 1982 - February 1994
American Hospital Supply / Baxter Healthcare 1982 - 1994
Community Hospital of Long Beach 1977 - 1982
Skills
Business Development, Selling, Real Estate, Training, Sales, Sales Management, Marketing, Negotiation, Market Development, Contract Negotiation, Executive Relocation, Business Coaching, Brand Management, Brand Awareness, New Business Development, Business Planning, Marketing Strategy, Product Launch, Customer Service, International Marketing, Advertising, First Time Home Buyers, Short Sales, REO, Full P&L Responsibility, Strategic Planning, Market Research, Marketing Communications, Product Positioning in..., Corporate Relocation, Sellers, Management, Leadership, Referrals, Foreclosures, Buyer Representation, Investors, Residential Homes, Buyers, Relocation, HUD, Luxury, Single Family Homes, Real Property, Listings, Condos, Real Estate Transactions, Seniors, Townhomes, FHA
Education
California State University-Long Beach 1979 — 1982
B.S., Health Science, Community Health Education
Long Beach City College 1977 — 1979
A.S., Respiratory Therapy, Science
Chinese American International School August 2015 - Present
Argonne Elementary School July 2015 - July 2015
Brookside Elementary School May 2015 - June 2015
Business Development and Marketing Consultant 2009 - June 2015
Pharmplast LLC January 2011 - July 2014
Respirics Inc. March 2004 - November 2008
Aerogen 2001 - 2004
PST Inc. 1999 - 2001
Medtronic AneuRx 1998 - 1999
Heartport Inc. 1996 - 1998
Skills
Market Development, Sustainability, Corporate Social..., Spanish Language, French Language, Medical Devices, Marketing Research, Business Development, Product Development, Start-ups, Product Marketing, Market Research, Marketing Management, Marketing, Spanish-speaking, Management, Analysis, Direct Sales, Entrepreneurship, Forecasting, French, Market Analysis, Program Management, Project Management, Sales, Spanish, Strategic Partnerships, Strategy, Sustainable Business, Business Strategy, Cross-functional Team..., Sustainability..., Business Planning, Product Management
Education
Bay Area Teacher Training Institute (BATTI) 2015 — 2017
Master's and Teaching Credential, Elementary Education and Teaching
University of California, Berkeley 2010 — 2011
Professional Certification, Sustainability Studies
Thunderbird School of Global Management 1990 — 1992
Master, International Business
Middlebury College 1983 — 1987
BA, Spanish & Comparative Animal Physiology, cum laude
The Branson School 1979 — 1983
Marin Country Day School 1976 — 1979
NJOY Electronic Cigarettes March 2014 - Present
Sunovion Respiratory Developmenet September 2012 - March 2014
Genentech 2013 - 2013
Elevation Pharmaceuticals 2012 - 2013
Alexza Pharmaceuticals September 2001 - February 2012
ZOLL Medical Corporation (formerly Revivant) September 1998 - September 2001
Aerogen July 1998 - September 1999
IDEO December 1995 - July 1997
Electro-Physiology Technologies February 1994 - December 1995
Skills
Solidworks, Spanish, Engineering, CAD, Biomedical Engineering, Design for Manufacturing, Medical Devices, Drug Delivery, Cross-functional Team..., Manufacturing, Mechanical Engineering, Product Development, Product Design, Start-ups, 3D Modeling, FDA, Design Control, Testing, R&D
Education
The Catholic University of America 1990 — 1992
MS, Biomedical Engineering
University of Maryland College Park 1984 — 1986
B.S., Mechanical Engineering
Frostburg State University 1982 — 1984
B.S., Physics
Aerogen February 2015 - Present
CareFusion May 2012 - February 2015
R1 Technologies 2007 - January 2012
PARI Respiratory Equipment 2006 - 2007
Cardinal Health June 1995 - December 2005
Skills
Medical Devices
Education
Northern Illinois University 1990 — 1994
BS, Healthcare-Marketing
Novartis/Nektar January 2009 - August 2014
Aerogen 2004 - 2006
FOREVER 21 INC January 2001 - January 2004
Skills
Customer Service, Testing, Microsoft Excel, Process Improvement, Manufacturing, Engineering, Project Management, Time Management, Team Building, Outlook, R&D, Inventory Management, Quality System, FDA, Quality Management, Medical Devices
Education
Notre Dame de Namur University 2010 — 2013
B.S, Human Services
Western Career College 2007 — 2009
A.S, Criminal Justices
Evergreen Valley College 2004 — 2006
G.E
Global Project Partners, LLC 2013 - Present
Integrated Project Management Co., Inc. 2005 - 2013
BioBright 2002 - 2005
New Channel, Inc. 2000 - 2001
Aerogen 1995 - 1999
Skills
Cross-functional Team..., Product Development, Medical Devices, Project Management, Program Management, Process Improvement, Leadership, PMP, Management, Strategic Planning, Business Development, Strategy, Lean Manufacturing, Cross Functional Team..., New Business Development, Business Process..., IVD, Drug Delivery
Education
California State University-East Bay 2001 — 2003
MBA, New Venture Management, Marketing
University of California, Berkeley
BS
Nektar Therapeutics January 2015 - Present
Nektar Therapeutics March 2012 - December 2014
PwC's PRTM Management Consultants August 2011 - February 2012
PRTM Management Consultants July 2007 - August 2011
Aerogen October 2004 - August 2005
Aerogen October 2003 - August 2005
Aerogen July 1997 - September 2003
Aerogen January 1997 - June 1997
Skills
Quality Systems, Product Development, Manufacturing, Medical Devices, Pharmaceuticals, Regulatory Risk, Program Management, Enterprise Risk..., Product Risk Management, Client Services, New Business Development, Client Engagement, Pharmaceutical Industry, Quality System, Engineering, Strategy, Management Consulting, Process Improvement, Process Engineering, FDA, Cross-functional Team..., Process Simulation, R&D, GMP, Management, Consulting, Leadership, Business Strategy, Change Management
Education
University of California, Los Angeles - The Anderson School of Management 2005 — 2007
MBA, Strategy and Operations
University of California, Berkeley 1992 — 1996
B.S., Chemical Engineering
Vidya Bhavan 1984 — 1986
Apple August 2012 - Present
Apple Inc. March 2011 - August 2012
Apple Computer August 2010 - May 2011
Independant Consultant June 2008 - August 2010
Immersion Corporation August 2002 - June 2008
Aerogen November 2001 - June 2002
Scalant Systems, Inc September 2000 - October 2001
Imaginative Products and Consulting Corporation June 1994 - June 2000
Stanford University January 1994 - May 1994
Parametric Technology Corporation May 1992 - December 1993
Skills
Engineering Management, Product Development, Quality Management, MRP, Solidworks, Interaction Design, Product Management, Product Design, Leadership, Semiconductors, Design for Manufacturing, Manufacturing, Product Lifecycle..., Engineering, Electronics, Mechanical Engineering, Medical Devices, Testing, R&D, Injection Molding, Rapid Prototyping, Industrial Design, Finite Element Analysis, Sheet Metal, SolidWorks
Education
Massachusetts Institute of Technology 1985 — 1987
Master of Science (M.S.), Mechanical Engineering
Massachusetts Institute of Technology 1981 — 1985
S.B., Mechanical Engineering
Novartis Pharmaceutical Corp May 2013 - Present
Novartis Pharmaceutics Corporation July 2009 - Present
Novartis Pharmaceuticals January 2009 - March 2010
Nektar Therapeutics October 2005 - December 2008
Nektar 2005 - 2008
Aerogen June 2004 - October 2005
ALZA Corporation September 2000 - June 2004
Education
Rochester Institute of Technology
MS
University of Hawaii at Manoa
BA, Psychology
12th Man Technologies, Inc. December 2010 - Present
CareFusion May 2008 - December 2010
Cardinal Health (Viasys Healthcare) August 2004 - May 2008
Johnson & Johnson 2007 - 2008
Rain Bird September 2004 - August 2005
Respironics November 2001 - September 2004
AeroGen March 1999 - November 2001
SEK Technology 1997 - 2001
SEK Technolongies May 1997 - March 1999
Skills
Medical Devices, Design for Manufacturing, FDA, Design Control, Solidworks, ISO 13485, ISO 14971, R&D, CAPA, Design of Experiments, Quality System, SPC, V&V, FMEA, Biomedical Engineering, Injection Molding, Manufacturing, Lean Manufacturing, Root Cause Analysis, Six Sigma, Validation, Manufacturing..., Minitab, Failure Analysis, Product Design, DMAIC, Engineering Management, ISO, Gage R&R, Pro Engineer, Finite Element Analysis, Process Simulation, GD&T, Kaizen, Product Launch, Product Development, Mechanical Engineering, Continuous Improvement, Cross-functional Team..., Tolerance Analysis, Machining, Plastics, Engineering, Supplier Quality, Sheet Metal, Machine Tools, Design for Assembly, Medical Device R&D, Manufacturing..., Labview
Education
University of California, San Diego 1994 — 1999
BS, Mechanical Engineering
Aerogen May 2013 - Present
CareFusion November 2007 - May 2013
Pfizer 2005 - 2005
Education
Northwestern University 1984 — 1985
Technical, Respiratory Therapy
Ferris State University 1977 — 1980
AAS, BS, Environmental Health and Safety
Aquinas College
Masters, Management
LifeLeaf 2011 - 2013
Signature Theraeputics 2010 - 2011
LexaMed 2010 - 2011
InterMune 2006 - 2007
Titan Pharmaceuticals 2004 - 2006
Aerogen 1997 - 2001
Skills
Pharmaceutical Industry, FDA, Medical Devices, Aseptic Processing, Quality Auditing, Leadership, ISO 13485, Quality Control, V&V, Quality Assurance, Biopharmaceuticals, Clinical Development, Validation, HPLC, CTMS, Biotechnology, Computer System..., Lifesciences, Pharmaceutics, Sop, CRO, Regulatory Requirements, GMP, Oncology, Clinical Trials, Microbiology, Quality System, CAPA, Change Control, GxP, GLP, 21 CFR Part 11, GCP, Drug Development, R&D, Regulatory Affairs, Technology Transfer, Cross-functional Team..., Regulatory Submissions, Cleaning Validation, LIMS, GAMP, IND, Vaccines, Design Control, Drug Delivery, Formulation
Education
Golden Gate University
Springfield High School, USDS
Translucent Inc September 2001 - Present
Aerogen March 2000 - September 2001
Topaz Technologies July 1998 - May 1999
Applied Magnetics Corp. December 1991 - July 1998
Flexure Assemblies, Inc. November 1989 - November 1990
Hughes Aircraft Company October 1985 - November 1989
Applied Magnetics Corporation October 1982 - October 1985
Quantrad Corporation February 1980 - October 1982
Skills
Semiconductors, Manufacturing, Analog Circuit Design, Solidworks, Machining, Thin Films, Equipment Maintenance, MOCVD, Process Equipment, Vacuum Chambers, Lathe, Optics, Management, Inventor, UHV, Facilities Management, AFM, R&D, Microsoft Office, Digital Circuit Design, Equipment Repair, Ellipsometry, Powder X-ray Diffraction, Optoelectronics, Clocks, Mastercam, Vertical Mill, Photonics, Characterization, Watch Repair, Mechatronics, MEMS, Micromachining, Soldering, Clock Repair, Sensors, Product Development, Engineering Management, Electronics, Design of Experiments, Cross-functional Team...
Education
University of California, Santa Barbara 1983 — 1990
Physics
Honeywell HomMed February 2009 - Present
Honeywell HomMed May 2003 - Present
Aerogen July 2001 - May 2003
Vital Signs May 1994 - June 1999
Skills
Medical Devices, Healthcare, New Business Development, Customer Engagement, Market Development, Cross-functional Team..., Product Launch, Capital Equipment, Sales Operations, Sales Management, Account Management
Education
University of Pittsburgh 1982 — 1986
Monessen HS
Fisher & Paykel Healthcare June 2015 - Present
Fisher & Paykel Healthcare December 2004 - Present
Aerogen May 2001 - July 2004
Vital Signs August 1995 - April 2001
Skills
Disposables, Medical Devices, Capital Equipment, Operating Room, Clinical Research, Cardiology, Surgeons, Market Development, Critical Care, Orthopedic, Product Launch, Sales Operations
Education
Texas Tech University 1981 — 1985
MS, Biochemistry/Neurophysiology
Texas Tech University 1977 — 1981
BS, Zoology/Chemistry
Self -Employed June 2015 - Present
Xoft Inc., a subsidiary of iCAD 2011 - June 2015
Xoft, Inc. 2009 - 2010
Xoft, Inc. 2008 - 2009
Xoft, Inc. 2003 - 2007
Aerogen 2000 - 2003
Boston Scientific 1995 - 2000
Skills
Product Development, R&D, Cross-functional Team..., FDA, Medical Devices, Design Control, ISO 13485, V&V, Medical Imaging, Capital Equipment, Product Launch, Validation, CAPA, Biomedical Engineering
Education
Purdue University
MSEE, Electrical and Electronics Engineering
Purdue University
BSEE, Electrical and Electronics Engineering
Grace Cathedral 2013 - 2013
Intel 1993 - 2012
McKesson 1992 - 2012
Aerogen 1998 - 2005
ALZA Corporation 1970 - 1994
Skills
Product Development, Medical Devices, FDA, Drug Delivery, R&D, ISO 13485, Lifesciences, Start-ups, Pharmaceutical Industry, Biotechnology, Process Improvement, Cross-functional Team..., Technology Transfer, Oncology, Project Management, Strategy, Clinical Development, Product Management, Product Launch, Clinical Trials, Informatics, Market Development, Licensing, Molecular Biology, Regulatory Affairs, Intellectual Property, Commercialization, Strategic Planning, Business Development, Biomedical Engineering, Drug Discovery, Venture Capital, V&V, Patents, GMP, Competitive Analysis, Healthcare, Entrepreneurship, Biopharmaceuticals, CAPA
Education
The University of Birmingham 1958 — 1964
BSc.,Ph.D, Physiology
Stanford University
SEP '92
Currently Retired June 2015 - Present
EarLens Corporation April 2014 - Present
Mizuho OSI March 2013 - Present
Barrx Medical January 2010 - June 2012
XTENT, Inc. November 2006 - December 2009
Bayhill Therapeutics 2005 - 2006
Aerogen 2004 - 2005
Curon Medical 2000 - 2004
Guidant 1998 - 2000
EVT 1992 - 2000
Skills
Quality System, Finance, Auditing, Revenue Recognition, Medical Devices, ISO 13485, Managerial Finance, Accounting, FDA, Sarbanes-Oxley Act, Forecasting, Process Improvement, Financial Accounting, Sarbanes-Oxley, Internal Audit, Manufacturing, Credit Analysis, Collections, Cross-functional Team...
Education
Santa Clara University 1982 — 1984
MBA, Accounting
University of California, Davis 1975 — 1979
Lockheed Martin April 2002 - Present
Foothill College / PAS 2005 - Present
Luxcore Networks 2001 - 2002
Aerogen 1995 - 1999
Skills
Systems Engineering, Space Systems, Simulations, Defense, Security Clearance, System Design, Requirements Management, Engineering Management, Proposal Writing, Optics, Matlab, DoD, Aerospace, Sensors, System Architecture
Education
Stanford University
Ph.D., Applied Mechanics / Physics
Sutter Health May 2013 - Present
FusionStorm February 2011 - May 2013
M/UX April 2005 - August 2008
Aerogen 1999 - 2001
Skills
HP, Cloud Computing, Data Center, VMware, Virtualization, AIX, Servers, Microsoft Exchange, System Administration, Troubleshooting, Citrix, DNS, Disaster Recovery, VMware ESX
Education
California Polytechnic State University-San Luis Obispo 1992 — 2007
Bachelor of Science (B.S.), Agricultural Engineering Technology
DFine, Inc. November 2007 - Present
Aerogen October 2000 - June 2007
Matrix Pharmaceuticals October 1993 - October 1997
Education
Hartnell College 1972 — 1975
Gonzales High
H. D. Smith 2015 - Present
Aerogen 2014 - Present
Tri-anim Health Services June 2012 - July 2014
Hemcon Medical Technologies July 2007 - 2012
Hemcon Medical Technologies 2007 - 2010
Cardinal Health 2004 - 2007
Cardinal Health , Specialty Pharmaceutical Distribution 2002 - 2004
Merck 2001 - 2002
Bindley Western Drug Company 1997 - 2001
Skills
Medical Devices, Account Management, Cross-functional Team..., Forecasting, Contract Negotiation, Consultative Selling, Team Building, Healthcare, Negotiation, Pharmaceutical Sales, New Product Launches, Selling, Managed Care, Strategy, Leadership, Sales Operations, Sales, Product Development, Product Launch, Sales Management
Education
Indiana University Bloomington
BSW, Social Work
EC Engineering Mechanical Design Engineer
Boston Scientific 2007 - 2010
Evalve, Inc. 2006 - 2007
Adiana 2001 - 2006
Starion Instruments 2000 - 2001
General Surgical Innovation 1998 - 2000
Aerogen 1995 - 1998
H&R Engineering Consultants 1993 - 1995
Becton Dickinson Immunocytometry System 1987 - 1993
Education
Cogswell Polytechnical College
Bachelor of Science (B.S.), Mechanical Engineering
De Anza College
Associate of Science (A.S.), Engineering technology
Velocity Pharmaceutical Development Consultant Project LeaderVelocity Pharmaceutical Development2012 - 2013
ZYDX, Inc. 2010 - 2012
MicroCHIPS, Inc. 2010 - 2011
Triaxis Medical Devices, Inc. 2008 - 2010
ALZA Corporation (J&J Inc.) 2006 - 2008
Chiron Corporation 2004 - 2006
Genentech 2001 - 2004
Aerogen 2000 - 2001
TheraSense (Abbott Pharmaceuticals, Inc.) 1998 - 2000
Sequus Pharmaceuticals, Inc. (J&J Inc.) 1995 - 1998
Education
Purdue University 1983 — 1988
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Purdue University 1979 — 1983
Bachelor's degree, Pharmacy
Affymetrix June 2007 - Present
Epitomics February 2005 - June 2007
GE Healthcare September 2000 - November 2004
Aerogen September 1997 - September 2000
Skills
Purchasing & Contract..., Forecasting & Planning, Performance Management, Inventory Control, Purchasing, Forecasting, Quality Control, Shipping, Project Planning, Sop, Vendor, MRP, Materials Management, Warehousing, Medical Devices, Biotechnology, Supply Chain Management, Communication Skills, Proactive Monitoring, Follow Through, Vendor Relationships, Lifesciences, Contract Negotiation, Logistics, Inventory Management, Production Planning, SOP
Education
University of Maryland Baltimore 1984 — 1988
De Anza College
Foothill College
NeoTract January 2011 - Present
Longwell & Associates 2008 - January 2011
Neuraltus Pharmaceuticals January 2009 - September 2010
Broncus Technologies 2005 - 2010
Aerogen 2002 - 2005
Becton Dickinson Immunocytometry Systems 1997 - 2002
Becton Dickinson Biosciences 1997 - 2002
Skills
Quality Assurance, Regulatory Affairs, FDA, Medical Devices, Clinical Trials, Biotechnology, ISO 13485, Change Control, Business Strategy, Health Law, Biologics, Quality System
Education
Boston University School of Law
JD, Law
Harvard School of Public Health
MPH, Health and Law
SFSU
BS, Cell and Molecular Biology
Self-employed 2009 - Present
TUV Rheinland 2003 - 2009
TUV Sud 2002 - 2003
HemoSense 1999 - 2001
AeroGen 1997 - 1999
Dade Behring 1991 - 1997
Sanofi 1986 - 1991
Beckman Coulter 1974 - 1986
Skills
IVDD, CMDCAS, ISO 13485, ISO 9001, FDA, CAPA, Manufacturing, Cross-functional Team..., Quality System, Validation, Quality Auditing, Quality Assurance, Medical Devices, Regulatory Affairs, Iso 9000, ISO 14971
Education
University of California, Irvine 1968 — 1973
BA Chemistry
Self-employed ConsultantBioDotDecember 2010 - Present
Nektar Therapeutics June 2005 - November 2009
Aerogen May 1995 - July 2005
Skills
Aerosol drug delivery :...
Education
Technion - Israel Institute of Technology 1976 — 1980
MSc, Mechanical Engineering
Providence Medical Technology, Inc. July 2014 - Present
DFine, Inc. January 2011 - June 2014
Independent Consultant April 2010 - January 2011
Vertos Medical Inc May 2009 - March 2010
Medtronic Spine & Biologics July 2008 - May 2009
Medtronic Spine & Biologics November 2007 - July 2008
Kyphon (Purchased by Medtronic) June 2004 - November 2007
Mission Medical April 2003 - May 2004
Aerogen March 2000 - January 2003
Zelos Consulting April 1998 - March 2000
Skills
Design Control, Spine, R&D, Medical Devices, ISO 13485, Design of Experiments, V&V, Product Design, Solidworks, Medical Device R&D
Education
University of Colorado Boulder
Bachelor of Science (BS), Mechanical Engineering