Hemosense Company
Industry: Company
DescriptionHeadquarters: San Jose, CA Founded: 1997 Parent organization: Alere Inc.
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Hemosense Employees
Employee
Years
Job
Industry
Edward Farnam Edward Farnam's Hemosense Experience July 2005 - March 2006
Job Sr. Process Engineer at Abaxis, Incorporated
Industry Medical Devices
Experience
Abaxis, Incorporated August 2014 - Present
Life Technologies October 2011 - April 2014
CIGHT--Center for Innovation in Global Health Technologies, Northwestern University April 2011 - June 2011
Paradise Century Homes May 2001 - December 2010
HemoSense July 2005 - March 2006
W.L.Gore & Associates December 2004 - June 2005
LifeScan September 1997 - May 2001
Boehringer Mannheim November 1996 - September 1997
Aquintel April 1996 - April 1997
Biometric Imaging November 1993 - April 1996
Skills
Biotechnology, HPLC, Validation, R&D, Medical Devices, Product Development, Technology Transfer, ISO 13485
Education
California State University, Fresno
Bachelor of Science (BS), Chemistry, 3.7 with Honors
Abaxis, Incorporated August 2014 - Present
Life Technologies October 2011 - April 2014
CIGHT--Center for Innovation in Global Health Technologies, Northwestern University April 2011 - June 2011
Paradise Century Homes May 2001 - December 2010
HemoSense July 2005 - March 2006
W.L.Gore & Associates December 2004 - June 2005
LifeScan September 1997 - May 2001
Boehringer Mannheim November 1996 - September 1997
Aquintel April 1996 - April 1997
Biometric Imaging November 1993 - April 1996
Skills
Biotechnology, HPLC, Validation, R&D, Medical Devices, Product Development, Technology Transfer, ISO 13485
Education
California State University, Fresno
Bachelor of Science (BS), Chemistry, 3.7 with Honors
Paul Katerges's Hemosense Experience October 1999 - August 2006
Job IT Manager at Consolidated Solar Technologies, LLC (et, al.)
Industry Information Technology and Services
Experience
Consolidated Solar Technologies / Mosher Enterprises / Great Western Specialty Systems August 2014 - Present
Paul Katerges - Tactical Computer Support April 2000 - Present
5.11 Tactical, Inc. February 2011 - July 2011
UC Davis Health System May 2010 - February 2011
Future US February 2008 - February 2009
HemoSense October 1999 - August 2006
CKS Group/US Web February 1998 - October 1999
Skills
Active Directory, Windows, Microsoft Exchange, Mac, Integration, Training, Customer Service, Windows 7, Technical Support, Product Management, Disaster Recovery, System Administration, Networking, Servers, Network Administration, VPN, TCP/IP, Software Documentation, System Deployment, Hardware, Switches, Help Desk Support
Education
Phillips Graduate Institute 1989 — 1991
AA, Paralegal Studies
Consolidated Solar Technologies / Mosher Enterprises / Great Western Specialty Systems August 2014 - Present
Paul Katerges - Tactical Computer Support April 2000 - Present
5.11 Tactical, Inc. February 2011 - July 2011
UC Davis Health System May 2010 - February 2011
Future US February 2008 - February 2009
HemoSense October 1999 - August 2006
CKS Group/US Web February 1998 - October 1999
Skills
Active Directory, Windows, Microsoft Exchange, Mac, Integration, Training, Customer Service, Windows 7, Technical Support, Product Management, Disaster Recovery, System Administration, Networking, Servers, Network Administration, VPN, TCP/IP, Software Documentation, System Deployment, Hardware, Switches, Help Desk Support
Education
Phillips Graduate Institute 1989 — 1991
AA, Paralegal Studies
Jon Gottfried Jon Gottfried's Hemosense Experience June 2005 - February 2006
Job Pharmaceutical, Medical Device & Biotechnology Consulting
Industry Biotechnology
Experience
TekTeam November 1999 - Present
Velomedix August 2012 - January 2014
Jan Medical 2012 - 2012
Abaxis 2010 - 2011
Abaxis 2010 - 2011
SkyLonda Mutual Water Company 1999 - 2008
LifeScan 1999 - 2008
Guava 2006 - 2007
HemoSense June 2005 - February 2006
Hemosense 1997 - 2005
Skills
Operational Planning, Quality Assurance, Validation, Writing, Planning, Technical Services, Editing, GMP, Testing, Regulatory Affairs, Clinical, Technology Evaluation, Clinical Development, Clinical Trials, Clinical Research, Cleaning Validation, Process Validation, SOP, Documentation, GxP, cGMP, GLP, QC, FDA, Pharmacovigilance, Strategic Planning, Computer System..., Medical Devices, Biotechnology, Quality System, ISO 13485, Lifesciences, Pharmaceutical Industry, R&D, Technology Transfer, Cross-functional Team..., Product Development, Design Control, Change Control, Manufacturing, Process Improvement, 21 CFR Part 11, Quality Auditing, Product Launch, Project Management, Technical Writing, Biopharmaceuticals, Pharmaceutics, Auditing, Commercialization
Education
St. Mary's College 2001 — 2002
MBA
Saint Mary's College of California 2000 — 2001
MBA
University of California, Santa Barbara 1986 — 1991
Biology
TekTeam November 1999 - Present
Velomedix August 2012 - January 2014
Jan Medical 2012 - 2012
Abaxis 2010 - 2011
Abaxis 2010 - 2011
SkyLonda Mutual Water Company 1999 - 2008
LifeScan 1999 - 2008
Guava 2006 - 2007
HemoSense June 2005 - February 2006
Hemosense 1997 - 2005
Skills
Operational Planning, Quality Assurance, Validation, Writing, Planning, Technical Services, Editing, GMP, Testing, Regulatory Affairs, Clinical, Technology Evaluation, Clinical Development, Clinical Trials, Clinical Research, Cleaning Validation, Process Validation, SOP, Documentation, GxP, cGMP, GLP, QC, FDA, Pharmacovigilance, Strategic Planning, Computer System..., Medical Devices, Biotechnology, Quality System, ISO 13485, Lifesciences, Pharmaceutical Industry, R&D, Technology Transfer, Cross-functional Team..., Product Development, Design Control, Change Control, Manufacturing, Process Improvement, 21 CFR Part 11, Quality Auditing, Product Launch, Project Management, Technical Writing, Biopharmaceuticals, Pharmaceutics, Auditing, Commercialization
Education
St. Mary's College 2001 — 2002
MBA
Saint Mary's College of California 2000 — 2001
MBA
University of California, Santa Barbara 1986 — 1991
Biology
Scott Segelke Scott Segelke's Hemosense Experience March 2002 - October 2004
Job Principal Process Development Engineer at Credence Medsystems
Industry Medical Devices
Experience
Credence Medsystems April 2013 - Present
Entourage Medical Technologies September 2011 - Present
Conor Medsystems November 2004 - August 2011
HemoSense March 2002 - October 2004
LifeScan 1996 - 2002
Apprise Inc 1989 - 1990
Skills
Validation, R&D, Biomaterials, FDA, Medical Devices, Design Control, Drug Delivery, ISO 13485, Design of Experiments, V&V, Process Simulation, Biomedical Engineering, CAPA, Testing, Technology Transfer, Product Development, Engineering, Manufacturing, Quality System, GMP, Biotechnology, Process Improvement
Education
Santa Clara University 1995 — 1998
MBA
Washington State University 1986 — 1988
MS, Chemical Engineering
San Jose State University 1982 — 1986
BS, Chemical Engineering
Credence Medsystems April 2013 - Present
Entourage Medical Technologies September 2011 - Present
Conor Medsystems November 2004 - August 2011
HemoSense March 2002 - October 2004
LifeScan 1996 - 2002
Apprise Inc 1989 - 1990
Skills
Validation, R&D, Biomaterials, FDA, Medical Devices, Design Control, Drug Delivery, ISO 13485, Design of Experiments, V&V, Process Simulation, Biomedical Engineering, CAPA, Testing, Technology Transfer, Product Development, Engineering, Manufacturing, Quality System, GMP, Biotechnology, Process Improvement
Education
Santa Clara University 1995 — 1998
MBA
Washington State University 1986 — 1988
MS, Chemical Engineering
San Jose State University 1982 — 1986
BS, Chemical Engineering
Timothy Still's Hemosense Experience 2004 - 2008
Job President and CEO / Medical Devices and Diagnostics
Industry Medical Devices
Experience
Xagenic Inc. 2014 - Present
Gold Standard Diagnostics 2014 - Present
Accumetrics 2008 - 2013
HemoSense 2004 - 2008
Cholestech 1997 - 2004
Roche / Boehringer Mannheim 1992 - 1997
Bio-Rad Laboratories 1990 - 1992
Skills
Medical Devices, Commercialization, Product Launch, Biotechnology, Market Development, Cross-functional Team..., Capital Equipment, Hardware Diagnostics, FDA, Lifesciences, Clinical Development, Business Development, Product Development, Pharmaceutical Industry, Start-ups, Strategic Planning, Marketing Strategy, Global Marketing, Business Strategy, Life Sciences, ISO 13485, Product Management, Cardiology, Sales Management, Quality System, Infectious Diseases, R&D, Sales Operations, CAPA, New Business Development, Manufacturing, Regulatory Affairs, Competitive Analysis, Clinical Trials, Validation, Hospitals, Process Improvement, Product Marketing, Healthcare, GMP, Technology Transfer, Six Sigma, Business Operations, Managed Care, Selling Skills, Quality Assurance, Quality Systems, Medical Diagnostics, Commercial Operations, Molecular Diagnostics
Education
University of Southern California - Marshall School of Business 1988 — 1990
MBA, Marketing, Entrepreneurship
University of California, Davis 1983 — 1988
Bachelor of Science, Biological Sciences
Xagenic Inc. 2014 - Present
Gold Standard Diagnostics 2014 - Present
Accumetrics 2008 - 2013
HemoSense 2004 - 2008
Cholestech 1997 - 2004
Roche / Boehringer Mannheim 1992 - 1997
Bio-Rad Laboratories 1990 - 1992
Skills
Medical Devices, Commercialization, Product Launch, Biotechnology, Market Development, Cross-functional Team..., Capital Equipment, Hardware Diagnostics, FDA, Lifesciences, Clinical Development, Business Development, Product Development, Pharmaceutical Industry, Start-ups, Strategic Planning, Marketing Strategy, Global Marketing, Business Strategy, Life Sciences, ISO 13485, Product Management, Cardiology, Sales Management, Quality System, Infectious Diseases, R&D, Sales Operations, CAPA, New Business Development, Manufacturing, Regulatory Affairs, Competitive Analysis, Clinical Trials, Validation, Hospitals, Process Improvement, Product Marketing, Healthcare, GMP, Technology Transfer, Six Sigma, Business Operations, Managed Care, Selling Skills, Quality Assurance, Quality Systems, Medical Diagnostics, Commercial Operations, Molecular Diagnostics
Education
University of Southern California - Marshall School of Business 1988 — 1990
MBA, Marketing, Entrepreneurship
University of California, Davis 1983 — 1988
Bachelor of Science, Biological Sciences
Dan Rozman Dan Rozman's Hemosense Experience February 2003 - May 2005
Job Business Development Manager at BloodCenter of Wisconsin
Industry Hospital & Health Care
Experience
BloodCenter of Wisconsin April 2015 - Present
ARUP Laboratories November 2007 - March 2015
4medica 2005 - 2007
Hemosense February 2003 - May 2005
Monaghan Medical 1998 - 2002
SCA Molnlycke 1996 - 1998
Beiersdorf Jobst 1987 - 1996
Skills
Healthcare, Consultative Selling, Sales Management, Start-ups, New Business Development, Market Development, Healthcare IT, Healthcare Information..., Selling, Medical Devices, Cross-functional Team..., Hospitals, Sales, Account Management, Product Launch, Managed Care, Sales Operations, Laboratory, Hematology, Capital Equipment, Contract Negotiation, Leadership, Salesforce.com, Product Management, Strategic Planning, Product Marketing, Strategy, Infectious Diseases, Team Building, Process Improvement, Business Development, Urology, Business Strategy, Healthcare Industry
Education
University of Maryland University College
BS, Business, Management, Marketing, and Related Support Services
BloodCenter of Wisconsin April 2015 - Present
ARUP Laboratories November 2007 - March 2015
4medica 2005 - 2007
Hemosense February 2003 - May 2005
Monaghan Medical 1998 - 2002
SCA Molnlycke 1996 - 1998
Beiersdorf Jobst 1987 - 1996
Skills
Healthcare, Consultative Selling, Sales Management, Start-ups, New Business Development, Market Development, Healthcare IT, Healthcare Information..., Selling, Medical Devices, Cross-functional Team..., Hospitals, Sales, Account Management, Product Launch, Managed Care, Sales Operations, Laboratory, Hematology, Capital Equipment, Contract Negotiation, Leadership, Salesforce.com, Product Management, Strategic Planning, Product Marketing, Strategy, Infectious Diseases, Team Building, Process Improvement, Business Development, Urology, Business Strategy, Healthcare Industry
Education
University of Maryland University College
BS, Business, Management, Marketing, and Related Support Services
Brian Tucker Brian Tucker's Hemosense Experience July 2005 - April 2006
Job Director of Sales, Dohmen Life Science Services | Uncovering Opportunities for Life Science Startups
Industry Medical Devices
Experience
Dohmen Life Science Services (formerly Reglera) October 2007 - Present
Sanarus Medical Inc April 2006 - March 2007
HemoSense July 2005 - April 2006
Medtronic February 2000 - April 2005
Roche Diagnostics/Boehringer Mannheim February 1993 - January 2000
Skills
Medical Devices, Business Development, Sales Operations, Product Development, Sales, Leadership, Sales Management, Management, Team Leadership, BioPharma Services, Pharma Supply Chain..., Medical Device..., Biotech Solutions, Life Science Outsourcing, Regulatory Affairs, Early-stage Startups, Product Management, Biotechnology, Product Marketing, Contract Negotiation, Pharmaceutical Industry, Product Launch
Education
University of Denver 1998 — 2000
MS in Management, Master of Healthcare Systems
The University of South Dakota 1982 — 1986
BS, Business Administration
Miller High School 1978 — 1982
Dohmen Life Science Services (formerly Reglera) October 2007 - Present
Sanarus Medical Inc April 2006 - March 2007
HemoSense July 2005 - April 2006
Medtronic February 2000 - April 2005
Roche Diagnostics/Boehringer Mannheim February 1993 - January 2000
Skills
Medical Devices, Business Development, Sales Operations, Product Development, Sales, Leadership, Sales Management, Management, Team Leadership, BioPharma Services, Pharma Supply Chain..., Medical Device..., Biotech Solutions, Life Science Outsourcing, Regulatory Affairs, Early-stage Startups, Product Management, Biotechnology, Product Marketing, Contract Negotiation, Pharmaceutical Industry, Product Launch
Education
University of Denver 1998 — 2000
MS in Management, Master of Healthcare Systems
The University of South Dakota 1982 — 1986
BS, Business Administration
Miller High School 1978 — 1982
Jason M. Tyler's Hemosense Experience October 2005 - July 2006
Job Territory Sales Manager at NanoEnTek
Industry Health, Wellness and Fitness
Experience
NanoEnTek November 2013 - Present
Horiba Medical March 2013 - October 2013
Alere, Inc. September 2007 - December 2012
Biosite July 2006 - September 2007
HemoSense October 2005 - July 2006
Berkeley HeartLab, Inc. July 2004 - September 2005
Cholestech January 1999 - May 2004
Skills
Sales Management and..., Marketing Strategy, Product Marketing, Product Management, Healthcare Information..., Cardiology, Capital Equipment, Sales, Sales Operations, Sales Management, Medical Devices, Cold Calling, Leadership, Product Launch, Sales Process, Management, Strategic Planning, Account Management, New Business Development, Marketing, Market Development, Salesforce.com, Healthcare, Hospitals, Contract Negotiation, Sales Presentations, Team Building, Training, Direct Sales
Education
Kansas State University 1990 — 1995
Bachelor of Applied Science (B.A.Sc.), Marketing and Public Relations
Copeland High School 1986 — 1990
NanoEnTek November 2013 - Present
Horiba Medical March 2013 - October 2013
Alere, Inc. September 2007 - December 2012
Biosite July 2006 - September 2007
HemoSense October 2005 - July 2006
Berkeley HeartLab, Inc. July 2004 - September 2005
Cholestech January 1999 - May 2004
Skills
Sales Management and..., Marketing Strategy, Product Marketing, Product Management, Healthcare Information..., Cardiology, Capital Equipment, Sales, Sales Operations, Sales Management, Medical Devices, Cold Calling, Leadership, Product Launch, Sales Process, Management, Strategic Planning, Account Management, New Business Development, Marketing, Market Development, Salesforce.com, Healthcare, Hospitals, Contract Negotiation, Sales Presentations, Team Building, Training, Direct Sales
Education
Kansas State University 1990 — 1995
Bachelor of Applied Science (B.A.Sc.), Marketing and Public Relations
Copeland High School 1986 — 1990
Brandon Toy Brandon Toy's Hemosense Experience June 2007 - April 2009
Job Facilities Manager at Phonak, LLC
Industry Medical Devices
Experience
Phonak, LLC. December 2011 - Present
InSound Medical August 2010 - December 2011
InSound Medical December 2009 - August 2010
InSound Medical October 2009 - December 2009
TechSkills August 2009 - November 2009
HemoSense June 2007 - April 2009
Adeza Biomedical October 2005 - June 2007
United States Marine Corp May 1999 - December 2006
Skills
Project Planning, Work Instructions, Troubleshooting, Medical Devices, Process Improvement, Manufacturing, Project Management, Software Documentation, Cross-functional Team..., Training, Sales Management, CRM, Healthcare, Sales Operations, Program Management, Product Development, Strategic Planning, Analysis, Product Launch, Testing, Leadership, Customer Satisfaction, Marketing
Education
TechSkills of Sacramento 2009 — 2009
A+ and N+
Santana High School 1996 — 1998
Diploma
Phonak, LLC. December 2011 - Present
InSound Medical August 2010 - December 2011
InSound Medical December 2009 - August 2010
InSound Medical October 2009 - December 2009
TechSkills August 2009 - November 2009
HemoSense June 2007 - April 2009
Adeza Biomedical October 2005 - June 2007
United States Marine Corp May 1999 - December 2006
Skills
Project Planning, Work Instructions, Troubleshooting, Medical Devices, Process Improvement, Manufacturing, Project Management, Software Documentation, Cross-functional Team..., Training, Sales Management, CRM, Healthcare, Sales Operations, Program Management, Product Development, Strategic Planning, Analysis, Product Launch, Testing, Leadership, Customer Satisfaction, Marketing
Education
TechSkills of Sacramento 2009 — 2009
A+ and N+
Santana High School 1996 — 1998
Diploma
Peter Aspuria's Hemosense Experience
Job Mfg Technician at Hemosense
Industry Medical Devices
Experience
Hemosense
Education
Saint Louis University (PH) 1973 — 1978
Hemosense
Education
Saint Louis University (PH) 1973 — 1978
David Ung's Hemosense Experience June 2007 - Present
Job Senior Manufacturing Engineer at Hemosense
Industry Biotechnology
Experience
Hemosense June 2007 - Present
Cholestech 2007 - 2009
Nektar August 2002 - June 2007
Roche Diagnostics 1995 - 2000
Education
California State Polytechnic University-Pomona
Hemosense June 2007 - Present
Cholestech 2007 - 2009
Nektar August 2002 - June 2007
Roche Diagnostics 1995 - 2000
Education
California State Polytechnic University-Pomona
Amber Martinez's Hemosense Experience May 2003 - March 2007
Job Principal Clinical Research Associate, Genomics and Oncology at Roche Molecular Systems
Industry Biotechnology
Experience
Roche Molecular Systems October 2011 - Present
Siemens Healthcare August 2007 - October 2011
Theranos March 2007 - June 2007
HemoSense May 2003 - March 2007
Microgenics July 2001 - May 2003
Avocet Medical November 1998 - June 2001
Good Samaritan Hospital 1991 - 1998
Skills
Biotechnology, Genomics, Infectious Diseases, Diagnostics, Oncology, PCR, RT-PCR, Genotyping, Microbiology, Virology, Sequencing, GMP, Clinical Trials, QC, Immunology, ELISA, FDA, Clinical Research, Medical Devices, Molecular Biology, GCP, ISO 13485, Clinical Trial..., Design Control, Quality Systems, CRO, Personalized Medicine, Molecular Diagnostics, IVD, qPCR, IRB, Informed Consent, Study Monitoring, eCRF, Site Initiation, Clinical Site Management, ICH guidelines, Medidata, EDC, Immunoassays, Quality System, CTMS, Lifesciences, Hardware Diagnostics
Education
University of California, Santa Cruz 2005 — 2008
Certificate, Biotechnology
University of California, Santa Cruz 2005 — 2007
Certificate, Clinical Trials Design and Management
San Jose State University 1991 — 1997
BS, Clinical Lab Sciences, minor in Chemistry
Roche Molecular Systems October 2011 - Present
Siemens Healthcare August 2007 - October 2011
Theranos March 2007 - June 2007
HemoSense May 2003 - March 2007
Microgenics July 2001 - May 2003
Avocet Medical November 1998 - June 2001
Good Samaritan Hospital 1991 - 1998
Skills
Biotechnology, Genomics, Infectious Diseases, Diagnostics, Oncology, PCR, RT-PCR, Genotyping, Microbiology, Virology, Sequencing, GMP, Clinical Trials, QC, Immunology, ELISA, FDA, Clinical Research, Medical Devices, Molecular Biology, GCP, ISO 13485, Clinical Trial..., Design Control, Quality Systems, CRO, Personalized Medicine, Molecular Diagnostics, IVD, qPCR, IRB, Informed Consent, Study Monitoring, eCRF, Site Initiation, Clinical Site Management, ICH guidelines, Medidata, EDC, Immunoassays, Quality System, CTMS, Lifesciences, Hardware Diagnostics
Education
University of California, Santa Cruz 2005 — 2008
Certificate, Biotechnology
University of California, Santa Cruz 2005 — 2007
Certificate, Clinical Trials Design and Management
San Jose State University 1991 — 1997
BS, Clinical Lab Sciences, minor in Chemistry
Elson Young's Hemosense Experience December 2006 - June 2008
Job Quality Complaint Investigation Lead at Optovue
Industry Medical Devices
Experience
Optovue December 2013 - Present
OptiMedica May 2012 - August 2013
DFine, Inc. June 2008 - December 2011
Dfine June 2008 - December 2011
HemoSense December 2006 - June 2008
Abbott Diabetes Care August 2004 - November 2006
Boston Scientific January 2003 - November 2004
Smart Therapeutics July 2001 - December 2002
Smart Therapeutics July 2001 - December 2002
Skills
Medical Devices, FDA, GMP, Quality Systems, cGMP, Root Cause Analysis, ISO 13485, Biotechnology, Quality Assurance, Quality System, Continuous Improvement, Software Documentation, CAPA, Quality Control, Design Control, Complaint Management, Validation, 21 CFR Part 11, V&V, Biomedical Engineering, R&D, Design of Experiments, Capital Equipment, ISO
Education
California State University-Hayward - School of Business and Economics 1995 — 1998
Bachelors, Kinesiology
Optovue December 2013 - Present
OptiMedica May 2012 - August 2013
DFine, Inc. June 2008 - December 2011
Dfine June 2008 - December 2011
HemoSense December 2006 - June 2008
Abbott Diabetes Care August 2004 - November 2006
Boston Scientific January 2003 - November 2004
Smart Therapeutics July 2001 - December 2002
Smart Therapeutics July 2001 - December 2002
Skills
Medical Devices, FDA, GMP, Quality Systems, cGMP, Root Cause Analysis, ISO 13485, Biotechnology, Quality Assurance, Quality System, Continuous Improvement, Software Documentation, CAPA, Quality Control, Design Control, Complaint Management, Validation, 21 CFR Part 11, V&V, Biomedical Engineering, R&D, Design of Experiments, Capital Equipment, ISO
Education
California State University-Hayward - School of Business and Economics 1995 — 1998
Bachelors, Kinesiology
Paul Chirico's Hemosense Experience 2002 - 2003
Job CEO for Silver Bullet Therapeutics
Industry Medical Devices
Experience
Silver Bullet Therapeutics, Inc. January 2010 - Present
SpineAlign Medical, Inc. June 2005 - Present
SpineAlign Medical (Formerly SpineWorks Medical) June 2005 - March 2010
Micrus Endovascular 2003 - 2006
Incyte Genomics January 2000 - January 2003
HemoSense 2002 - 2003
Avocet 1997 - 2000
Avocet Medical 1997 - 2000
Cholestech 1994 - 1997
LaserScope 1992 - 1994
Skills
Medical Devices, Design Control, Start-ups, Product Management, R&D, Product Development, Competitive Analysis, FDA, Capital Equipment, Marketing Strategy, Market Development, Product Launch, Lifesciences, Marketing, Biotechnology, ISO 13485, New Business Development, Clinical Trials, Healthcare, Regulatory Affairs, Manufacturing, Commercialization, Orthopedic, Cross-functional Team..., Quality System, Biomedical Engineering, CAPA, Pharmaceutical Industry, Global Marketing, Orthopedics, Life Sciences
Education
Santa Clara University 1983 — 1986
MBA, Accounting Emphasis
Santa Clara University 1975 — 1979
BS, Biology
Silver Bullet Therapeutics, Inc. January 2010 - Present
SpineAlign Medical, Inc. June 2005 - Present
SpineAlign Medical (Formerly SpineWorks Medical) June 2005 - March 2010
Micrus Endovascular 2003 - 2006
Incyte Genomics January 2000 - January 2003
HemoSense 2002 - 2003
Avocet 1997 - 2000
Avocet Medical 1997 - 2000
Cholestech 1994 - 1997
LaserScope 1992 - 1994
Skills
Medical Devices, Design Control, Start-ups, Product Management, R&D, Product Development, Competitive Analysis, FDA, Capital Equipment, Marketing Strategy, Market Development, Product Launch, Lifesciences, Marketing, Biotechnology, ISO 13485, New Business Development, Clinical Trials, Healthcare, Regulatory Affairs, Manufacturing, Commercialization, Orthopedic, Cross-functional Team..., Quality System, Biomedical Engineering, CAPA, Pharmaceutical Industry, Global Marketing, Orthopedics, Life Sciences
Education
Santa Clara University 1983 — 1986
MBA, Accounting Emphasis
Santa Clara University 1975 — 1979
BS, Biology
Judith Blunt's Hemosense Experience 1999 - 2004
Job Principal Consultant at RAQACA Consulting
Industry Medical Devices
Experience
RAQACA Consulting September 2014 - Present
Zyomyx February 2014 - August 2014
23andMe November 2011 - January 2014
XDx August 2010 - November 2011
Novartis Diagnostics May 2006 - August 2010
Cepheid April 2005 - May 2006
InSite Vision August 2004 - April 2005
HemoSense 1999 - 2004
HemoSense (an Inverness Medical Company) 1999 - 2004
Avocet Medical 1997 - 1999
Skills
FDA, Biotechnology, Medical Devices, Lifesciences, Clinical Trials, ISO 13485, Regulatory Affairs, Clinical Research, Design Control, Quality System, Pharmaceutical Industry, Clinical Development, Validation, Oncology, Sop, IVD, R&D, Molecular Diagnostics, CAPA, CTMS, GMP, Regulatory Submissions, Laboratory, Quality Assurance, Hardware Diagnostics, V&V, Assay Development, GCP, Biopharmaceuticals, Regulatory Requirements, GLP, 21 CFR Part 11, Product Launch, Technology Transfer, Drug Development, GxP, Commercialization, Personalized Medicine, Medical Diagnostics
Education
University of California, San Francisco 1983 — 1986
M.S., Clinical Science
California State Polytechnic University-Pomona 1972 — 1976
BS, Microbiology
RAQACA Consulting September 2014 - Present
Zyomyx February 2014 - August 2014
23andMe November 2011 - January 2014
XDx August 2010 - November 2011
Novartis Diagnostics May 2006 - August 2010
Cepheid April 2005 - May 2006
InSite Vision August 2004 - April 2005
HemoSense 1999 - 2004
HemoSense (an Inverness Medical Company) 1999 - 2004
Avocet Medical 1997 - 1999
Skills
FDA, Biotechnology, Medical Devices, Lifesciences, Clinical Trials, ISO 13485, Regulatory Affairs, Clinical Research, Design Control, Quality System, Pharmaceutical Industry, Clinical Development, Validation, Oncology, Sop, IVD, R&D, Molecular Diagnostics, CAPA, CTMS, GMP, Regulatory Submissions, Laboratory, Quality Assurance, Hardware Diagnostics, V&V, Assay Development, GCP, Biopharmaceuticals, Regulatory Requirements, GLP, 21 CFR Part 11, Product Launch, Technology Transfer, Drug Development, GxP, Commercialization, Personalized Medicine, Medical Diagnostics
Education
University of California, San Francisco 1983 — 1986
M.S., Clinical Science
California State Polytechnic University-Pomona 1972 — 1976
BS, Microbiology
Paul Descheneaux's Hemosense Experience November 2006 - November 2007
Job Director of Corporate Accounts
Industry Medical Devices
Experience
Accriva Diagnostics November 2012 - Present
OraSure Technologies May 2012 - November 2012
Alere, Inc. November 2007 - March 2012
HemoSense November 2006 - November 2007
Streck, Inc April 2004 - October 2006
Fisher HealthCare December 1995 - March 2004
Elan Diagnostic 1995 - 1996
Curtin Matheson Scientific 1978 - 1995
Skills
Medical Devices, Capital Equipment, Biotechnology, Market Development, Infectious Diseases, Hardware Diagnostics, Leadership, Sales Management, Sales Operations, Strategy, Immunoassays, Cardiology, Healthcare, Product Launch, Hematology
Education
Saint Louis University 1972 — 1976
BA, Chemistry, Biology
Accriva Diagnostics November 2012 - Present
OraSure Technologies May 2012 - November 2012
Alere, Inc. November 2007 - March 2012
HemoSense November 2006 - November 2007
Streck, Inc April 2004 - October 2006
Fisher HealthCare December 1995 - March 2004
Elan Diagnostic 1995 - 1996
Curtin Matheson Scientific 1978 - 1995
Skills
Medical Devices, Capital Equipment, Biotechnology, Market Development, Infectious Diseases, Hardware Diagnostics, Leadership, Sales Management, Sales Operations, Strategy, Immunoassays, Cardiology, Healthcare, Product Launch, Hematology
Education
Saint Louis University 1972 — 1976
BA, Chemistry, Biology
Hyejung (Christie) Lee's Hemosense Experience March 2006 - January 2009
Job Bioprocess Engineer
Industry Medical Devices
Experience
BD Biosciences October 2010 - October 2011
HemoSense March 2006 - January 2009
Abbott Laboratories February 2000 - March 2006
Skills
Reagent Development, Process Development, Flow Cytometry, Hematology, Coagulation, Data Analysis, Database Administration, database management, Quality Assurance, SQL, PL/SQL, Medical Devices, Instrument Development, CAPA, Process Simulation, Database Admin, Cross-functional Team..., V&V, Biotechnology, Assay Development, Validation, Testing, Negotiable Instruments, Design Control
Education
University of California, Berkeley 1992 — 1996
BS, Chemistry
Foothill College 2009 — 2010
AS, Oracle Database Management
BD Biosciences October 2010 - October 2011
HemoSense March 2006 - January 2009
Abbott Laboratories February 2000 - March 2006
Skills
Reagent Development, Process Development, Flow Cytometry, Hematology, Coagulation, Data Analysis, Database Administration, database management, Quality Assurance, SQL, PL/SQL, Medical Devices, Instrument Development, CAPA, Process Simulation, Database Admin, Cross-functional Team..., V&V, Biotechnology, Assay Development, Validation, Testing, Negotiable Instruments, Design Control
Education
University of California, Berkeley 1992 — 1996
BS, Chemistry
Foothill College 2009 — 2010
AS, Oracle Database Management
Steve Perdue's Hemosense Experience 2004 - 2007
Job Medical Devices Production Manager
Industry Medical Devices
Experience
EarLens Corporation August 2010 - May 2012
Apieron Inc. 2008 - 2010
HemoSense 2004 - 2007
Cholestech Corporation 1990 - 2003
Skills
Medical Devices, Start-ups, ISO 13485, FDA, Quality System
Education
California State University-East Bay 1978 — 1980
BS, Biology
University of California, Berkeley 1974 — 1977
BA, Geography
EarLens Corporation August 2010 - May 2012
Apieron Inc. 2008 - 2010
HemoSense 2004 - 2007
Cholestech Corporation 1990 - 2003
Skills
Medical Devices, Start-ups, ISO 13485, FDA, Quality System
Education
California State University-East Bay 1978 — 1980
BS, Biology
University of California, Berkeley 1974 — 1977
BA, Geography
Meow Yen Sim's Hemosense Experience 2008 - 2009
Job Chemist
Industry Medical Devices
Experience
Abaxis 2012 - 2012
Abaxis 2012 - 2012
Cholestech Inc March 2008 - January 2010
Inverness Medical (Formerly Cholestech) March 2008 - January 2010
Cholestech, an Inverness Medical Innovations Company 2008 - 2010
HemoSense 2008 - 2009
Inverness Innovations April 2007 - December 2008
Skills
FDA, Validation, Manufacturing, Process Engineering, CAPA, GMP
Education
San Jose State University
MS, Chemical Engineering
San Jose State University
BS, Chemical Engineering
Abaxis 2012 - 2012
Abaxis 2012 - 2012
Cholestech Inc March 2008 - January 2010
Inverness Medical (Formerly Cholestech) March 2008 - January 2010
Cholestech, an Inverness Medical Innovations Company 2008 - 2010
HemoSense 2008 - 2009
Inverness Innovations April 2007 - December 2008
Skills
FDA, Validation, Manufacturing, Process Engineering, CAPA, GMP
Education
San Jose State University
MS, Chemical Engineering
San Jose State University
BS, Chemical Engineering
Jennifer Szonye's Hemosense Experience June 2006 - June 2008
Job QA & Document Services Specialist at Ariosa Diagnostics
Industry Medical Devices
Experience
Ariosa Diagnostics July 2011 - Present
Crescendo Bioscience June 2010 - July 2011
Various Diagnostic Companies March 2009 - June 2010
Aviir, Inc. June 2008 - March 2009
HemoSense June 2006 - June 2008
SurgRx April 2005 - June 2006
Boston Scientific November 2004 - April 2005
Natus Medical September 2003 - August 2004
Aradigm Corporation May 2004 - June 2004
Phaton August 2003 - August 2003
Skills
FDA, Quality Assurance, Document Management, ISO, ISO 13485, Medical Devices, Quality Control, Change Control, CAPA, Validation
Education
University of Phoenix 2005 — 2007
BS
De Anza College 2001 — 2004
AA
Copper Connection 2000 — 2000
Certificate
Batavia School of Drafting 1996 — 1997
Certificate
Ariosa Diagnostics July 2011 - Present
Crescendo Bioscience June 2010 - July 2011
Various Diagnostic Companies March 2009 - June 2010
Aviir, Inc. June 2008 - March 2009
HemoSense June 2006 - June 2008
SurgRx April 2005 - June 2006
Boston Scientific November 2004 - April 2005
Natus Medical September 2003 - August 2004
Aradigm Corporation May 2004 - June 2004
Phaton August 2003 - August 2003
Skills
FDA, Quality Assurance, Document Management, ISO, ISO 13485, Medical Devices, Quality Control, Change Control, CAPA, Validation
Education
University of Phoenix 2005 — 2007
BS
De Anza College 2001 — 2004
AA
Copper Connection 2000 — 2000
Certificate
Batavia School of Drafting 1996 — 1997
Certificate
PETER LY's Hemosense Experience May 1970 - November 1970
Job Senior Chemist at Abaxis, Inc.
Industry Medical Devices
Experience
Abaxis, Inc. August 2014 - Present
Intuity Medical, Inc. January 2008 - April 2014
Quidel Corporation January 2003 - May 2007
Systems Complete, LLC October 1999 - October 2002
Biomedix, Inc. May 1998 - September 1999
Litmus Concepts, Inc. June 1992 - April 1998
SmithKline Diagnostics December 1985 - June 1992
Primary Diagnostic Systems, Inc. February 1984 - December 1985
SmithKline Instruments, Inc. September 1978 - October 1982
Hemosense May 1970 - November 1970
Skills
Medical Devices, Immunoassays, Assay Development, FDA, Lifesciences, Clinical Trials, Biotechnology, Technology Transfer, Infectious Diseases, Assay Method..., Micro-fluidic Device..., Antibody Development,..., Process Development and..., FDA Quality Systems and..., Enzymatic Method..., Material Sciences, Reagent Formulation..., Polymer Coatings, Statistical Analysis..., Protein Assays, Protein Purification, GMP/QSR Regulations and..., Supplier Sourcing, Supplier Development, Supplier Risk Management, Supplier Evaluation, Supplier Quality..., R&D, Validation, V&V, ELISA, Design Control, ISO 13485, Cross-functional Team..., GMP, Clinical Data Management, Materials Science, Polymers, Life Sciences
Education
University of California, Davis 1970 — 1975
Bachelor of Science (B.Sc.), Biological Sciences
San Francisco State University
Master of Science (M.Sc.), Clinical Chemistry and Microbiology, Clinical Chemistry and Microbiology
Abaxis, Inc. August 2014 - Present
Intuity Medical, Inc. January 2008 - April 2014
Quidel Corporation January 2003 - May 2007
Systems Complete, LLC October 1999 - October 2002
Biomedix, Inc. May 1998 - September 1999
Litmus Concepts, Inc. June 1992 - April 1998
SmithKline Diagnostics December 1985 - June 1992
Primary Diagnostic Systems, Inc. February 1984 - December 1985
SmithKline Instruments, Inc. September 1978 - October 1982
Hemosense May 1970 - November 1970
Skills
Medical Devices, Immunoassays, Assay Development, FDA, Lifesciences, Clinical Trials, Biotechnology, Technology Transfer, Infectious Diseases, Assay Method..., Micro-fluidic Device..., Antibody Development,..., Process Development and..., FDA Quality Systems and..., Enzymatic Method..., Material Sciences, Reagent Formulation..., Polymer Coatings, Statistical Analysis..., Protein Assays, Protein Purification, GMP/QSR Regulations and..., Supplier Sourcing, Supplier Development, Supplier Risk Management, Supplier Evaluation, Supplier Quality..., R&D, Validation, V&V, ELISA, Design Control, ISO 13485, Cross-functional Team..., GMP, Clinical Data Management, Materials Science, Polymers, Life Sciences
Education
University of California, Davis 1970 — 1975
Bachelor of Science (B.Sc.), Biological Sciences
San Francisco State University
Master of Science (M.Sc.), Clinical Chemistry and Microbiology, Clinical Chemistry and Microbiology
Kevin Shuler's Hemosense Experience January 2003 - May 2005
Job Real Estate Agent at Keller Williams Realty/The Anderson Real Estate Group
Industry Medical Devices
Experience
Keller Williams Realty/The Anderson Real Estate Group January 2014 - Present
eCardio Diagnostics June 2006 - December 2013
Inovise Medical, Inc. June 2005 - June 2006
HemoSense January 2003 - May 2005
Viacord 2000 - 2003
Biostar 1997 - 2000
Eli Lilly September 1988 - March 1997
LaBelles 1982 - 1984
Skills
Medical Devices, Cardiology, Sales Management, Sales, Start-ups, Account Management, Healthcare, Sales Operations, Business Development, Strategic Planning, Product Development, Hospitals, Market Development, Biotechnology, Training, New Business Development, Business Strategy, Product Launch, Product Management, Marketing, Capital Equipment
Education
University of Southern California - Marshall School of Business 1993 — 1995
MBA, Marketing, Consulting
University of Arizona 1984 — 1988
BA, Biology, Chemistry, Psychology, General Studies
Keller Williams Realty/The Anderson Real Estate Group January 2014 - Present
eCardio Diagnostics June 2006 - December 2013
Inovise Medical, Inc. June 2005 - June 2006
HemoSense January 2003 - May 2005
Viacord 2000 - 2003
Biostar 1997 - 2000
Eli Lilly September 1988 - March 1997
LaBelles 1982 - 1984
Skills
Medical Devices, Cardiology, Sales Management, Sales, Start-ups, Account Management, Healthcare, Sales Operations, Business Development, Strategic Planning, Product Development, Hospitals, Market Development, Biotechnology, Training, New Business Development, Business Strategy, Product Launch, Product Management, Marketing, Capital Equipment
Education
University of Southern California - Marshall School of Business 1993 — 1995
MBA, Marketing, Consulting
University of Arizona 1984 — 1988
BA, Biology, Chemistry, Psychology, General Studies
Rachelle Cainey's Hemosense Experience October 2003 - July 2005
Job Sales operations Manager at Accumetrics
Industry Medical Devices
Experience
Accumetrics January 2011 - Present
Accumetrics March 2009 - January 2011
HemoSense / Inverness October 2005 - February 2009
HemoSense October 2003 - July 2005
HemoSense March 2003 - October 2003
Skills
Medical Devices, Strategic Planning, Start-ups, Excel, Sales Operations, Sales Support, Sales Process, Forecasting, Cross-functional Team..., Sales Management, Healthcare, Lifesciences, Process Improvement, Sales Force Development, Salesforce.com, Hospitals, Capital Equipment, Sales Presentations, Business Development, Validation, Sop, Biotechnology, GMP, Training, Cold Calling, Operating Room, Project Management, Selling, Microsoft Excel
Education
Creighton University 1997 — 2001
St. Mary's College of California 1997 — 2001
Accumetrics January 2011 - Present
Accumetrics March 2009 - January 2011
HemoSense / Inverness October 2005 - February 2009
HemoSense October 2003 - July 2005
HemoSense March 2003 - October 2003
Skills
Medical Devices, Strategic Planning, Start-ups, Excel, Sales Operations, Sales Support, Sales Process, Forecasting, Cross-functional Team..., Sales Management, Healthcare, Lifesciences, Process Improvement, Sales Force Development, Salesforce.com, Hospitals, Capital Equipment, Sales Presentations, Business Development, Validation, Sop, Biotechnology, GMP, Training, Cold Calling, Operating Room, Project Management, Selling, Microsoft Excel
Education
Creighton University 1997 — 2001
St. Mary's College of California 1997 — 2001
Rusty James's Hemosense Experience January 2004 - October 2006
Job Microbiologist Business Specialist at bioMerieux
Industry Medical Devices
Experience
bioMerieux September 2014 - Present
T-System Inc. January 2013 - September 2014
RevCycle+ December 2012 - September 2014
Alere, Inc., formerly Biosite, Inc. October 2006 - December 2012
HemoSense January 2004 - October 2006
Ortho Clinical Diagnositcs January 2002 - January 2004
Abbott Diagnostics January 2000 - January 2002
Abbott Diagnositics June 1995 - January 2000
Abbott Laboratories January 1994 - June 1995
Mercy Health Center January 1991 - December 1993
Skills
Capital Equipment, Medical Devices, Hospitals, Cardiology, Hematology, Healthcare, Sales Force Development, Sales Operations, Competitive Analysis, Direct Sales, Sales, Business Development, New Business Development, Salesforce.com, Selling, Biotechnology, Product Launch, Cross-functional Team...
Education
Oklahoma State University 1985 — 1989
B.S.
bioMerieux September 2014 - Present
T-System Inc. January 2013 - September 2014
RevCycle+ December 2012 - September 2014
Alere, Inc., formerly Biosite, Inc. October 2006 - December 2012
HemoSense January 2004 - October 2006
Ortho Clinical Diagnositcs January 2002 - January 2004
Abbott Diagnostics January 2000 - January 2002
Abbott Diagnositics June 1995 - January 2000
Abbott Laboratories January 1994 - June 1995
Mercy Health Center January 1991 - December 1993
Skills
Capital Equipment, Medical Devices, Hospitals, Cardiology, Hematology, Healthcare, Sales Force Development, Sales Operations, Competitive Analysis, Direct Sales, Sales, Business Development, New Business Development, Salesforce.com, Selling, Biotechnology, Product Launch, Cross-functional Team...
Education
Oklahoma State University 1985 — 1989
B.S.
Mike Henighan's Hemosense Experience May 2005 - May 2008
Job CFO at WaferGen
Industry Medical Devices
Experience
WaferGen August 2014 - Present
Aplegen, Inc. February 2011 - Present
Consulting in Finance & Accounting October 2009 - February 2011
Alpha Innotech May 2008 - October 2009
HemoSense May 2005 - May 2008
Cholestech 1997 - 2005
Solectron 1995 - 1997
Applied Biosystems 1989 - 1995
motorola June 1982 - September 1989
Occidental Paper Corp June 1980 - June 1982
Skills
Cross-functional Team..., Biotechnology, Medical Devices, Sarbanes-Oxley Act, Cost Accounting, Start-ups, Mergers & Acquisitions, Process Improvement, Mergers, Lifesciences, Revenue Recognition, SEC filings, Project Management, Strategic Planning, Forecasting, Commercialization, Management
Education
California State University-Los Angeles 1970 — 1975
BS, Accunting
WaferGen August 2014 - Present
Aplegen, Inc. February 2011 - Present
Consulting in Finance & Accounting October 2009 - February 2011
Alpha Innotech May 2008 - October 2009
HemoSense May 2005 - May 2008
Cholestech 1997 - 2005
Solectron 1995 - 1997
Applied Biosystems 1989 - 1995
motorola June 1982 - September 1989
Occidental Paper Corp June 1980 - June 1982
Skills
Cross-functional Team..., Biotechnology, Medical Devices, Sarbanes-Oxley Act, Cost Accounting, Start-ups, Mergers & Acquisitions, Process Improvement, Mergers, Lifesciences, Revenue Recognition, SEC filings, Project Management, Strategic Planning, Forecasting, Commercialization, Management
Education
California State University-Los Angeles 1970 — 1975
BS, Accunting
Michealle Havenhill's Hemosense Experience December 2001 - Present
Job Director, Quality Control at HemoSense
Industry Biotechnology
Experience
HemoSense December 2001 - Present
Education
San Jose State University 1978 — 1983
HemoSense December 2001 - Present
Education
San Jose State University 1978 — 1983
Patrick Mercer's Hemosense Experience May 2007 - November 2008
Job Vice President of Manufacturing at RODO Medical
Industry Medical Devices
Experience
RODO Medical May 2015 - Present
DFine, Inc. November 2008 - December 2014
HemoSense May 2007 - November 2008
Revivant 2002 - 2007
Stryker Endoscopy 2001 - 2002
Kimberly-Clark 1999 - 2001
US Navy 1990 - 1994
Education
University of Alabama 1995 — 1998
BS EE, Electrical Engineer/Computer Engineering
APICS CSCP CLASS
RODO Medical May 2015 - Present
DFine, Inc. November 2008 - December 2014
HemoSense May 2007 - November 2008
Revivant 2002 - 2007
Stryker Endoscopy 2001 - 2002
Kimberly-Clark 1999 - 2001
US Navy 1990 - 1994
Education
University of Alabama 1995 — 1998
BS EE, Electrical Engineer/Computer Engineering
APICS CSCP CLASS
Ji Lin's Hemosense Experience 2007 - 2008
Job Technical manager | in vitro diagnostics | biotechnology
Industry Medical Devices
Experience
Abbott 2014 - Present
Abbott Hematology 2012 - 2014
Abbott Hematology 2011 - 2012
Abbott Hematology 2008 - 2011
Hemosense 2007 - 2008
Oncologic 2005 - 2007
Skills
Biotechnology, GMP, FDA, Medical Devices, Validation, Lifesciences, Pharmaceutical Industry, V&V, CAPA, GLP, Quality System, Design Control, Change Control, Product Life Cycle, Reagents, Assay Development, FMEA, Manufacturing, ICH guidelines, Clinical Research, Medicine, Risk Management, Obesity, Cancer, Radioimmunoassay, Biomarkers, Analytical Skills, Presentations, Design of Experiments, Investigation, Molecular Diagnostics, Leadership, Cross-functional Team..., Life Sciences
Education
The University of Georgia
Doctor of Philosophy (PhD), Physiology
Nanjing Medical University
Doctor of Medicine (MD), Medicine
Abbott 2014 - Present
Abbott Hematology 2012 - 2014
Abbott Hematology 2011 - 2012
Abbott Hematology 2008 - 2011
Hemosense 2007 - 2008
Oncologic 2005 - 2007
Skills
Biotechnology, GMP, FDA, Medical Devices, Validation, Lifesciences, Pharmaceutical Industry, V&V, CAPA, GLP, Quality System, Design Control, Change Control, Product Life Cycle, Reagents, Assay Development, FMEA, Manufacturing, ICH guidelines, Clinical Research, Medicine, Risk Management, Obesity, Cancer, Radioimmunoassay, Biomarkers, Analytical Skills, Presentations, Design of Experiments, Investigation, Molecular Diagnostics, Leadership, Cross-functional Team..., Life Sciences
Education
The University of Georgia
Doctor of Philosophy (PhD), Physiology
Nanjing Medical University
Doctor of Medicine (MD), Medicine
Bill Durrett's Hemosense Experience June 2004 - October 2007
Job VP Customer Experience at Lumenis
Industry Medical Devices
Experience
Lumenis VP Customer ExperienceLumenis2007 - Present
HemoSense June 2004 - October 2007
Cholestech 2002 - 2004
Syva (a Syntex Company) 1976 - 1996
DADE BEHRING / ROCHE DIAGNOSTICS / SYVA 1976 - 1996
Skills
Medical Devices, Product Development
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1988 — 1990
Lumenis VP Customer ExperienceLumenis2007 - Present
HemoSense June 2004 - October 2007
Cholestech 2002 - 2004
Syva (a Syntex Company) 1976 - 1996
DADE BEHRING / ROCHE DIAGNOSTICS / SYVA 1976 - 1996
Skills
Medical Devices, Product Development
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1988 — 1990
Sarah Royer's Hemosense Experience January 2007 - December 2008
Job Manufacturing Supervisor at HemoSense
Industry Medical Devices
Experience
HemoSense January 2007 - December 2008
HemoSense January 2004 - January 2007
Macys West October 2000 - July 2004
Wet Seal, Inc July 1999 - July 2000
Skills
Cross-functional Team..., Team Building, Biotechnology, GMP, FDA, Organization, Interpersonal Skill, Life Sciences, Management, Customer Service, CAPA, ISO 13485, Medical Devices
Education
California State University at East bay 2012 — 2015
Bachelor's degree Industrial Organizational Psychology (B.S.), I/O Psychology, GPA 3.7
Ohlone College 2000 — 2012
Human development studies, Psychology, GPA 3.5
HemoSense January 2007 - December 2008
HemoSense January 2004 - January 2007
Macys West October 2000 - July 2004
Wet Seal, Inc July 1999 - July 2000
Skills
Cross-functional Team..., Team Building, Biotechnology, GMP, FDA, Organization, Interpersonal Skill, Life Sciences, Management, Customer Service, CAPA, ISO 13485, Medical Devices
Education
California State University at East bay 2012 — 2015
Bachelor's degree Industrial Organizational Psychology (B.S.), I/O Psychology, GPA 3.7
Ohlone College 2000 — 2012
Human development studies, Psychology, GPA 3.5
Michealle Havenhill's Hemosense Experience December 2001 - January 2007
Job Quality Assurance Manager at Advanced Cell Diagnostics
Industry Biotechnology
Experience
Advanced Cell Diagnostics June 2013 - Present
Knightsbridge Plastics, Inc July 2012 - May 2013
TMPI Precision Cleaning 2010 - 2011
HemoSense December 2001 - January 2007
Beckman Coulter 2000 - 2001
Beckman Coulter 1997 - 2000
Skills
ISO 13485, Quality System, CAPA, Validation, Continuous Improvement, Quality Control, Testing, Auditing, FDA, Design Control, V&V, GMP, Medical Devices
Education
San Jose State University
Bachelors, Zoology
Advanced Cell Diagnostics June 2013 - Present
Knightsbridge Plastics, Inc July 2012 - May 2013
TMPI Precision Cleaning 2010 - 2011
HemoSense December 2001 - January 2007
Beckman Coulter 2000 - 2001
Beckman Coulter 1997 - 2000
Skills
ISO 13485, Quality System, CAPA, Validation, Continuous Improvement, Quality Control, Testing, Auditing, FDA, Design Control, V&V, GMP, Medical Devices
Education
San Jose State University
Bachelors, Zoology
Pete Reddy Jr.'s Hemosense Experience 2004 - 2008
Job at
Industry Biotechnology
Experience
Nitinol Devices & Components, Inc. March 2014 - Present
Nitinol Devices & Components, Inc. January 2011 - Present
Cholestech November 2008 - November 2009
HemoSense 2004 - 2008
Skills
Medical Devices
Education
San Jose City College
H.V.A.C.R.
Nitinol Devices & Components, Inc. March 2014 - Present
Nitinol Devices & Components, Inc. January 2011 - Present
Cholestech November 2008 - November 2009
HemoSense 2004 - 2008
Skills
Medical Devices
Education
San Jose City College
H.V.A.C.R.
Ed Tacdol's Hemosense Experience 2000 - 2006
Job Clinical Research Consultant
Industry Medical Devices
Experience
Cerus Corporation November 2013 - Present
Tibion Corporation January 2012 - February 2013
St. Jude Medical March 2006 - June 2011
coagusense 2009 - 2009
HemoSense 2000 - 2006
Beckman Coulter 2000 - 2001
Skills
21 CFR Part 11, Biomedical Engineering, Biotechnology, CAPA, CRO, CTMS, Capital Equipment, Cardiology, Clinical Data Management, Clinical Development, Clinical Research, Clinical Monitoring, Clinical Study Design, Clinical Trials, Cross-functional Team..., Design Control, EDC, Electrophysiology, FDA, FDA GMP, GCP, GLP, GMP, Hardware Diagnostics, Hospitals, Heart Failure, ICH guidelines, ICH-GCP, ISO 13485, IVD, Interventional..., Infectious Diseases, Medical Devices, Lifesciences, Oncology, Orthopedic, PMA, Pharmaceutical Industry, Protocol, Product Launch, Quality System, R, Regulatory Affairs, Regulatory Submissions, Research, Sop, Spine, Surgery, Urology, V
Education
Cal Poly San Luis Obispo 1992 — 1996
Bachelor Degree of Science (B.Sc.), Biology/Biological Sciences, General
Cerus Corporation November 2013 - Present
Tibion Corporation January 2012 - February 2013
St. Jude Medical March 2006 - June 2011
coagusense 2009 - 2009
HemoSense 2000 - 2006
Beckman Coulter 2000 - 2001
Skills
21 CFR Part 11, Biomedical Engineering, Biotechnology, CAPA, CRO, CTMS, Capital Equipment, Cardiology, Clinical Data Management, Clinical Development, Clinical Research, Clinical Monitoring, Clinical Study Design, Clinical Trials, Cross-functional Team..., Design Control, EDC, Electrophysiology, FDA, FDA GMP, GCP, GLP, GMP, Hardware Diagnostics, Hospitals, Heart Failure, ICH guidelines, ICH-GCP, ISO 13485, IVD, Interventional..., Infectious Diseases, Medical Devices, Lifesciences, Oncology, Orthopedic, PMA, Pharmaceutical Industry, Protocol, Product Launch, Quality System, R, Regulatory Affairs, Regulatory Submissions, Research, Sop, Spine, Surgery, Urology, V
Education
Cal Poly San Luis Obispo 1992 — 1996
Bachelor Degree of Science (B.Sc.), Biology/Biological Sciences, General
Robert Blackwell's Hemosense Experience October 2003 - May 2004
Job Associate Director, Systems Engineering at Grifols Diagnostic Solutions
Industry Biotechnology
Experience
Grifols Diagnostic Solutions January 2014 - Present
Novartis Diagnostics July 2013 - January 2014
Berkeley HeartLab, Inc. May 2005 - June 2013
Boston Scientific May 2004 - May 2005
HemoSense October 2003 - May 2004
Functional Test Specialists LLC October 2001 - October 2002
Omneon, Inc. January 2001 - October 2001
Acuson July 1992 - January 2001
Rose Communications July 1991 - July 1992
Cholestech May 1990 - June 1991
Skills
Clinical Development, FDA, Lifesciences, Biotechnology, Formal requirements and..., Qualification and..., Hardware and software..., Capability analysis and..., Hardware abstraction..., Data acquistion., Image acquisition., Data communications:..., Sensors and detectors., FPGA and PAL design., Processor, memory and..., Signal conditioning., Human factors in..., Statistics and..., Signal filtering., Convolutions and..., File information..., Languages: Java, C,..., Root cause analysis., FDA/ISO compliant..., Cost/benefit analysis., Project and business..., R&D, Fault Analysis, Manufacturing, Quality System, V&V, Data Acquisition, Medical Devices, ISO 13485, Embedded Systems, Hardware Diagnostics, Validation, Quality Assurance, Algorithm Design, Laboratory, Signal Conditioning, GMP, Testing, Root Cause Analysis, Sop, Assay Development, GLP, LIMS, Engineering, Process Improvement
Education
California State University-Hayward 2003 — 2006
Master's degree, Computer Science
California State Polytechnic University-Pomona 1979 — 1981
Bachelor's degree, Electrical and Electronics Engineering
Santa Monica College 1977 — 1979
Associate of Arts (A.A.), Engineering
Grifols Diagnostic Solutions January 2014 - Present
Novartis Diagnostics July 2013 - January 2014
Berkeley HeartLab, Inc. May 2005 - June 2013
Boston Scientific May 2004 - May 2005
HemoSense October 2003 - May 2004
Functional Test Specialists LLC October 2001 - October 2002
Omneon, Inc. January 2001 - October 2001
Acuson July 1992 - January 2001
Rose Communications July 1991 - July 1992
Cholestech May 1990 - June 1991
Skills
Clinical Development, FDA, Lifesciences, Biotechnology, Formal requirements and..., Qualification and..., Hardware and software..., Capability analysis and..., Hardware abstraction..., Data acquistion., Image acquisition., Data communications:..., Sensors and detectors., FPGA and PAL design., Processor, memory and..., Signal conditioning., Human factors in..., Statistics and..., Signal filtering., Convolutions and..., File information..., Languages: Java, C,..., Root cause analysis., FDA/ISO compliant..., Cost/benefit analysis., Project and business..., R&D, Fault Analysis, Manufacturing, Quality System, V&V, Data Acquisition, Medical Devices, ISO 13485, Embedded Systems, Hardware Diagnostics, Validation, Quality Assurance, Algorithm Design, Laboratory, Signal Conditioning, GMP, Testing, Root Cause Analysis, Sop, Assay Development, GLP, LIMS, Engineering, Process Improvement
Education
California State University-Hayward 2003 — 2006
Master's degree, Computer Science
California State Polytechnic University-Pomona 1979 — 1981
Bachelor's degree, Electrical and Electronics Engineering
Santa Monica College 1977 — 1979
Associate of Arts (A.A.), Engineering
Jessica Bustamante's Hemosense Experience February 2004 - December 2008
Job seeking a position in the medical or dental industry
Industry Hospital & Health Care
Experience
You Smile Dental May 2015 - Present
center of cosmetic dentistry July 2013 - June 2015
Carrington College September 2012 - June 2013
Thomas West Inc July 2011 - September 2012
Olympus Medical October 2010 - April 2011
Cholestech December 2008 - November 2009
HemoSense February 2004 - December 2008
Skills
ISO 13485, Quality Assurance, Medical Devices, Design Control, CAPA, FDA, V&V, Manufacturing, Testing, Validation, Quality System, 21 CFR Part 11, Troubleshooting, Process Improvement, GMP
Education
Carrington College California-San Jose 2012 — 2013
Medical Admin/Billing & Coding
You Smile Dental May 2015 - Present
center of cosmetic dentistry July 2013 - June 2015
Carrington College September 2012 - June 2013
Thomas West Inc July 2011 - September 2012
Olympus Medical October 2010 - April 2011
Cholestech December 2008 - November 2009
HemoSense February 2004 - December 2008
Skills
ISO 13485, Quality Assurance, Medical Devices, Design Control, CAPA, FDA, V&V, Manufacturing, Testing, Validation, Quality System, 21 CFR Part 11, Troubleshooting, Process Improvement, GMP
Education
Carrington College California-San Jose 2012 — 2013
Medical Admin/Billing & Coding
Lewis Farris's Hemosense Experience 1999 - 2001
Job Independent consultant at Selfemployed
Industry Medical Devices
Experience
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 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
Jennifer Merritt's Hemosense Experience November 2006 - December 2008
Job Commercial Director VetCareShare at Elucidate, Inc.
Industry Information Technology and Services
Experience
Elucidate, Inc. June 2015 - Present
OraSure Technologies May 2014 - May 2015
ITC November 2009 - February 2014
International Technidyne Corporation November 2009 - February 2014
Drugs of Abuse November 2006 - November 2009
Inverness Medical Innovations January 2008 - April 2009
HemoSense November 2006 - December 2008
Inverness Medical September 2004 - November 2006
Quest Diagnostics October 2000 - September 2004
PPD ATP October 1999 - October 2000
Skills
Account Management, Medical Devices, Sales Management, New Business Development, Capital Equipment, Direct Sales, Sales, Sales Process, Key Account Management, Cold Calling, Sales Operations, Salesforce.com, Business Development, Negotiation, Selling, Management, Marketing, Market Development, Product Launch, Leadership, Training
Education
North Carolina State University 1994 — 1998
Bachelor of Arts, Communications; Interpersonal Communication
Elucidate, Inc. June 2015 - Present
OraSure Technologies May 2014 - May 2015
ITC November 2009 - February 2014
International Technidyne Corporation November 2009 - February 2014
Drugs of Abuse November 2006 - November 2009
Inverness Medical Innovations January 2008 - April 2009
HemoSense November 2006 - December 2008
Inverness Medical September 2004 - November 2006
Quest Diagnostics October 2000 - September 2004
PPD ATP October 1999 - October 2000
Skills
Account Management, Medical Devices, Sales Management, New Business Development, Capital Equipment, Direct Sales, Sales, Sales Process, Key Account Management, Cold Calling, Sales Operations, Salesforce.com, Business Development, Negotiation, Selling, Management, Marketing, Market Development, Product Launch, Leadership, Training
Education
North Carolina State University 1994 — 1998
Bachelor of Arts, Communications; Interpersonal Communication
julie antonio-sipin's Hemosense Experience April 2007 - November 2007
Job QC Associate Chemist at Thermo Fisher Scientific
Industry Biotechnology
Experience
Thermo Fisher Scientific November 2012 - Present
Nanosys April 2013 - September 2013
Progenitor Cell Therapy March 2011 - November 2012
Abbott Diagnostics January 2007 - June 2008
HemoSense April 2007 - November 2007
Abbott Diagnostics September 1999 - April 2007
Spectra Laboratories 1997 - 2000
Spectra Laboratories 1997 - 2000
Kaiser Permanente July 1999 - September 1999
Spectra Laboratories December 1995 - July 1999
Skills
GMP, Cell, Quality Control, Validation, Assay Development, GLP, Laboratory, Biotechnology, Deviations, FDA, Sop, instrumentation, trouble shooting, SOP, Microbiology, Chemistry, Quality Assurance, UV/Vis, Life Sciences, Cell Culture, Organic Chemistry, Pharmaceutical Industry, Hematology, Molecular Biology
Education
Lyceum Northwestern University 1985 — 1989
Bachelor of Science, Medical Technology
Thermo Fisher Scientific November 2012 - Present
Nanosys April 2013 - September 2013
Progenitor Cell Therapy March 2011 - November 2012
Abbott Diagnostics January 2007 - June 2008
HemoSense April 2007 - November 2007
Abbott Diagnostics September 1999 - April 2007
Spectra Laboratories 1997 - 2000
Spectra Laboratories 1997 - 2000
Kaiser Permanente July 1999 - September 1999
Spectra Laboratories December 1995 - July 1999
Skills
GMP, Cell, Quality Control, Validation, Assay Development, GLP, Laboratory, Biotechnology, Deviations, FDA, Sop, instrumentation, trouble shooting, SOP, Microbiology, Chemistry, Quality Assurance, UV/Vis, Life Sciences, Cell Culture, Organic Chemistry, Pharmaceutical Industry, Hematology, Molecular Biology
Education
Lyceum Northwestern University 1985 — 1989
Bachelor of Science, Medical Technology
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY