Experien Group
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Experien Group Employees
Employee
Years
Job
Industry
Sammi Lotti Sammi Lotti's Experien Group Experience June 2013 - September 2013
Job Graduate Student at University of Illinois Urbana Champaign
Industry Higher Education
Experience
University of Illinois at Urbana-Champaign August 2014 - Present
UC Davis September 2011 - June 2014
Experien Group June 2013 - September 2013
UC Davis Veterinary Medical Teaching Hospital January 2012 - May 2013
VCA Animal Hospitals January 2010 - September 2010
Skills
Biochemistry, Genetics, Animal Welfare, Animal Models, Transgenics, Animal Husbandry, Lifesciences, Life Sciences, Event Planning, Teamwork, Data Analysis, Teaching
Education
University of Illinois at Urbana-Champaign 2014 — 2016
Master's Degree, Animal Sciences
University of California, Davis 2010 — 2014
Bachelor's degree, Animal Sciences
University of Illinois at Urbana-Champaign August 2014 - Present
UC Davis September 2011 - June 2014
Experien Group June 2013 - September 2013
UC Davis Veterinary Medical Teaching Hospital January 2012 - May 2013
VCA Animal Hospitals January 2010 - September 2010
Skills
Biochemistry, Genetics, Animal Welfare, Animal Models, Transgenics, Animal Husbandry, Lifesciences, Life Sciences, Event Planning, Teamwork, Data Analysis, Teaching
Education
University of Illinois at Urbana-Champaign 2014 — 2016
Master's Degree, Animal Sciences
University of California, Davis 2010 — 2014
Bachelor's degree, Animal Sciences
Lonny Cummings Lonny Cummings's Experien Group Experience March 2010 - March 2011
Job Sr Quality Engineer at Abbott Medical Optics
Industry Medical Devices
Experience
Abbott Medical Optics August 2013 - Present
OptiMedica (a Wholly Owned Subsidiary of Abbot Medical Optics) May 2011 - August 2013
OptiMedica February 2011 - May 2011
Experien Group March 2010 - March 2011
Experien Group December 2009 - February 2010
Experien Group August 2009 - November 2009
Boston Scientific September 2008 - February 2009
Boston Scientific June 2006 - August 2008
Thoratec October 2005 - March 2006
Siemens Healthcare - Ultrasound Division June 2004 - October 2005
Skills
FDA, ISO 13485, Quality System, CAPA, Design Control, Medical Devices, FMEA, Software Documentation, Process Improvement, ISO, Validation, ISO 14971, V&V, Quality Auditing, 21 CFR, Product Development
Education
Kettering University 1983 — 1988
BSME, Mechanical Engineering
Abbott Medical Optics August 2013 - Present
OptiMedica (a Wholly Owned Subsidiary of Abbot Medical Optics) May 2011 - August 2013
OptiMedica February 2011 - May 2011
Experien Group March 2010 - March 2011
Experien Group December 2009 - February 2010
Experien Group August 2009 - November 2009
Boston Scientific September 2008 - February 2009
Boston Scientific June 2006 - August 2008
Thoratec October 2005 - March 2006
Siemens Healthcare - Ultrasound Division June 2004 - October 2005
Skills
FDA, ISO 13485, Quality System, CAPA, Design Control, Medical Devices, FMEA, Software Documentation, Process Improvement, ISO, Validation, ISO 14971, V&V, Quality Auditing, 21 CFR, Product Development
Education
Kettering University 1983 — 1988
BSME, Mechanical Engineering
Gina Catalano's Experien Group Experience March 2011 - March 2015
Job
Industry Medical Devices
Experience
Private biotechnology company April 2015 - Present
Experien Group March 2011 - March 2015
Education
Northeastern University
Santa Clara University 2006 — 2010
BS
Salinas High School 2002 — 2006
HS Diploma
Private biotechnology company April 2015 - Present
Experien Group March 2011 - March 2015
Education
Northeastern University
Santa Clara University 2006 — 2010
BS
Salinas High School 2002 — 2006
HS Diploma
Anna Libman Anna Libman's Experien Group Experience August 2014 - Present
Job Manager, Regulatory Affairs, MBA Candidate UCLA Anderson
Industry Medical Devices
Experience
Experien Group August 2014 - Present
Experien Group October 2010 - August 2014
Experien Group October 2010 - July 2011
Wei Laboratories June 2010 - October 2010
UC Davis Medical Center October 2009 - December 2009
The Artemis Project May 2009 - August 2009
University of California March 2009 - June 2009
Pacific Vision Institute September 2007 - January 2008
Skills
Medical Devices, Regulatory Affairs, FDA, Regulatory Submissions, Clinical Trials, ISO 13485, Design Control, Biotechnology, Mobile Applications, Mobile Devices, Strategic Thinking, Problem Solving, Project Management
Education
UCLA Anderson School of Management 2014 — 2017
MBA, Finance and Entrepreneurship
University of California, Davis 2006 — 2010
B.S, Biochemistry and Technology Management
De Anza College
Experien Group August 2014 - Present
Experien Group October 2010 - August 2014
Experien Group October 2010 - July 2011
Wei Laboratories June 2010 - October 2010
UC Davis Medical Center October 2009 - December 2009
The Artemis Project May 2009 - August 2009
University of California March 2009 - June 2009
Pacific Vision Institute September 2007 - January 2008
Skills
Medical Devices, Regulatory Affairs, FDA, Regulatory Submissions, Clinical Trials, ISO 13485, Design Control, Biotechnology, Mobile Applications, Mobile Devices, Strategic Thinking, Problem Solving, Project Management
Education
UCLA Anderson School of Management 2014 — 2017
MBA, Finance and Entrepreneurship
University of California, Davis 2006 — 2010
B.S, Biochemistry and Technology Management
De Anza College
Irma Soriano's Experien Group Experience May 2010 - May 2011
Job Executive Assistant at Citi Ventures
Industry Executive Office
Experience
Citi Ventures July 2015 - Present
Amazon Lab126 January 2014 - June 2015
Accenture May 2011 - January 2014
Experien Group May 2010 - May 2011
PricewaterhouseCoopers September 2006 - May 2010
Clearfield Job Corps Center May 2005 - September 2006
Washington Mutual December 1998 - March 2005
Cylink Corporation May 1994 - December 1998
Skills
Event Planning, Administrative..., Microsoft Excel, Human Resources, PowerPoint, Office Management, Management, Event Management, Team Building, Project Management, Executive Level..., Travel Arrangements, Visas, Passport, Lotus Notes, Contract Recruitment, Heavy Calendaring, Executive Calendar..., SharePoint, Translation..., Customer Service, Executive..., Outlook, Microsoft Office, Program Management
Education
San Jose State University 1988 — 1998
William C. Overfelt High School
Citi Ventures July 2015 - Present
Amazon Lab126 January 2014 - June 2015
Accenture May 2011 - January 2014
Experien Group May 2010 - May 2011
PricewaterhouseCoopers September 2006 - May 2010
Clearfield Job Corps Center May 2005 - September 2006
Washington Mutual December 1998 - March 2005
Cylink Corporation May 1994 - December 1998
Skills
Event Planning, Administrative..., Microsoft Excel, Human Resources, PowerPoint, Office Management, Management, Event Management, Team Building, Project Management, Executive Level..., Travel Arrangements, Visas, Passport, Lotus Notes, Contract Recruitment, Heavy Calendaring, Executive Calendar..., SharePoint, Translation..., Customer Service, Executive..., Outlook, Microsoft Office, Program Management
Education
San Jose State University 1988 — 1998
William C. Overfelt High School
Shannon Poff's Experien Group Experience September 2014 - April 2015
Job Business Unit Coordinator at Jabil
Industry Electrical/Electronic Manufacturing
Experience
Jabil May 2015 - Present
Experien Group September 2014 - April 2015
Experien Group June 2013 - September 2014
Experien Group November 2012 - June 2013
Orange Label Art + Advertising January 2012 - April 2012
McCormick & Schmick's November 2010 - March 2012
The Resort at Pelican Hill October 2009 - November 2010
Skills
Marketing, Social Networking, Customer Service, Social Media, Social Media Marketing, Teamwork, Leadership, Microsoft Office, Marketing Communications, Research, Time Management, Market Research, Communication, Multitasking, Microsoft Excel, Microsoft Word
Education
California State University-Fullerton 2009 — 2012
Bachelor of Arts, Marketing
Jabil May 2015 - Present
Experien Group September 2014 - April 2015
Experien Group June 2013 - September 2014
Experien Group November 2012 - June 2013
Orange Label Art + Advertising January 2012 - April 2012
McCormick & Schmick's November 2010 - March 2012
The Resort at Pelican Hill October 2009 - November 2010
Skills
Marketing, Social Networking, Customer Service, Social Media, Social Media Marketing, Teamwork, Leadership, Microsoft Office, Marketing Communications, Research, Time Management, Market Research, Communication, Multitasking, Microsoft Excel, Microsoft Word
Education
California State University-Fullerton 2009 — 2012
Bachelor of Arts, Marketing
Kat (Lynch) Brunner Kat (Lynch) Brunner's Experien Group Experience June 2015 - Present
Job Business Development Associate at Experien Group
Industry Medical Devices
Experience
Experien Group June 2015 - Present
Stanford Office of Public Affairs, Special Events & Protocol April 2015 - June 2015
Stanford Pre-Collegiate Studies, Collegiate Programs April 2014 - April 2015
Stanford Pre-Collegiate Studies, Collegiate Programs October 2014 - February 2015
Stanford Pre-Collegiate Studies, Enrichment Programs December 2012 - April 2014
Stanford Alumni Association September 2012 - October 2012
Lourus Co., Ltd. October 2011 - June 2012
Stanford Scientific May 2010 - June 2011
The Beaverton Valley Times June 2010 - September 2010
Russia Today October 2009 - December 2009
Skills
Editing, Event Planning, Research, Microsoft Office, Customer Service, Close Attention to..., Leadership, Social Media, Public Speaking, Meet Deadlines, Public Relations, PowerPoint, Sports, Facebook, Data Entry, PC, Mac, Collaborative Problem..., Stanford Oracle Finance, Cybersource, PeopleSoft, Nonprofits, Microsoft Excel, Higher Education, Communication, Interviews
Education
Stanford University 2007 — 2011
B.A
Experien Group June 2015 - Present
Stanford Office of Public Affairs, Special Events & Protocol April 2015 - June 2015
Stanford Pre-Collegiate Studies, Collegiate Programs April 2014 - April 2015
Stanford Pre-Collegiate Studies, Collegiate Programs October 2014 - February 2015
Stanford Pre-Collegiate Studies, Enrichment Programs December 2012 - April 2014
Stanford Alumni Association September 2012 - October 2012
Lourus Co., Ltd. October 2011 - June 2012
Stanford Scientific May 2010 - June 2011
The Beaverton Valley Times June 2010 - September 2010
Russia Today October 2009 - December 2009
Skills
Editing, Event Planning, Research, Microsoft Office, Customer Service, Close Attention to..., Leadership, Social Media, Public Speaking, Meet Deadlines, Public Relations, PowerPoint, Sports, Facebook, Data Entry, PC, Mac, Collaborative Problem..., Stanford Oracle Finance, Cybersource, PeopleSoft, Nonprofits, Microsoft Excel, Higher Education, Communication, Interviews
Education
Stanford University 2007 — 2011
B.A
Mark Holdbrook Mark Holdbrook's Experien Group Experience December 2009 - May 2014
Job Clinical Research Executive
Industry Medical Devices
Experience
Oculeve Inc. May 2014 - Present
Experien Group December 2009 - May 2014
Santen Inc. May 2000 - November 2009
KeraVision, Inc 1995 - 2000
Education
University of California, San Diego 1974 — 1977
Oculeve Inc. May 2014 - Present
Experien Group December 2009 - May 2014
Santen Inc. May 2000 - November 2009
KeraVision, Inc 1995 - 2000
Education
University of California, San Diego 1974 — 1977
Michelle Schmidt Michelle Schmidt's Experien Group Experience January 2015 - Present
Job Executive Assistant at Experien Group
Industry Consumer Services
Experience
Experien Group January 2015 - Present
Experien Group November 2012 - October 2013
McCormick & Schmick’s Grille May 2010 - July 2012
Garden Grove Unified School District January 2010 - May 2011
Ralph Brennan’s Jazz Kitchen August 2005 - March 2010
Skills
Customer Service, Microsoft Office, Adapt Quickly to Change, Analyze Problems, Organization, Diplomacy, Highly personable, Enthusiasm to learn, Event Planning, Event Management, Sales Management, Restaurant Management, Teamwork, Budgets, Microsoft Word, Sales, Microsoft Excel, Training
Education
California State University-Long Beach 2006 — 2009
Bachelor of Arts (B.A.), Liberal Arts and Sciences/Liberal Studies
California State University-Long Beach 2006 — 2009
Teaching Credential, Elementary Education and Teaching
Cypress College 2003 — 2006
Experien Group January 2015 - Present
Experien Group November 2012 - October 2013
McCormick & Schmick’s Grille May 2010 - July 2012
Garden Grove Unified School District January 2010 - May 2011
Ralph Brennan’s Jazz Kitchen August 2005 - March 2010
Skills
Customer Service, Microsoft Office, Adapt Quickly to Change, Analyze Problems, Organization, Diplomacy, Highly personable, Enthusiasm to learn, Event Planning, Event Management, Sales Management, Restaurant Management, Teamwork, Budgets, Microsoft Word, Sales, Microsoft Excel, Training
Education
California State University-Long Beach 2006 — 2009
Bachelor of Arts (B.A.), Liberal Arts and Sciences/Liberal Studies
California State University-Long Beach 2006 — 2009
Teaching Credential, Elementary Education and Teaching
Cypress College 2003 — 2006
Alyssia Ferrari's Experien Group Experience September 2012 - November 2012
Job Customer Engagement Manager at Egnyte
Industry Computer Software
Experience
Egnyte July 2015 - Present
Egnyte December 2014 - July 2015
Egnyte July 2014 - December 2014
MyoScience September 2013 - February 2014
Nordstrom April 2013 - November 2013
Experien Group September 2012 - November 2012
Experien Group July 2011 - September 2012
Disability Group Inc December 2010 - June 2011
Loyola Marymount University August 2007 - May 2009
Sino Restaurant March 2007 - August 2007
Skills
Microsoft Office, Marketing Strategy, Customer Service, Facebook, Program Management, Strategic Planning, Event Management, Public Speaking, Management, Leadership, Time Management, Microsoft Excel, Public Relations, Account Management, Lead Generation, Sales, Customer Retention, Vlookup
Education
Loyola Marymount University 2006 — 2010
Bachelor of Business Administration, Marketing
Loyola Marymount University, College of Business Administration 2006 — 2010
Bachelor of Business Administration (B.B.A.), Marketing
Egnyte July 2015 - Present
Egnyte December 2014 - July 2015
Egnyte July 2014 - December 2014
MyoScience September 2013 - February 2014
Nordstrom April 2013 - November 2013
Experien Group September 2012 - November 2012
Experien Group July 2011 - September 2012
Disability Group Inc December 2010 - June 2011
Loyola Marymount University August 2007 - May 2009
Sino Restaurant March 2007 - August 2007
Skills
Microsoft Office, Marketing Strategy, Customer Service, Facebook, Program Management, Strategic Planning, Event Management, Public Speaking, Management, Leadership, Time Management, Microsoft Excel, Public Relations, Account Management, Lead Generation, Sales, Customer Retention, Vlookup
Education
Loyola Marymount University 2006 — 2010
Bachelor of Business Administration, Marketing
Loyola Marymount University, College of Business Administration 2006 — 2010
Bachelor of Business Administration (B.B.A.), Marketing
Charles Parnham's Experien Group Experience April 2013 - July 2014
Job Principal at Parnham, Inc.
Industry Medical Devices
Experience
Parnham, Inc. April 2015 - Present
Vention Medical July 2014 - April 2015
Experien Group April 2013 - July 2014
Nitinol Devices & Components, Inc. October 2009 - April 2013
Parnham, Inc. June 2004 - October 2009
NeuColl June 2000 - May 2004
Skills
Design Control, Start-ups, Design Development, Design Validation, DOE, Process Validation, ISO 14971, FMEA, cGMP, QSR, ISO 13485, V&V, Quality System, GMP, Medical Devices, Design Research, Validation, Pharmaceutical Industry, Product Development, Product Launch, Quality Assurance, Quality Management, Design of Experiments, ISO, CAPA, Quality Control, Manufacturing, Root Cause Analysis, R&D, Commercialization, Testing, Regulatory Submissions, Biomedical Engineering, Process Simulation, Biotechnology, Software Documentation, Clinical Trials, Minitab, Lifesciences, Technology Transfer, Cross-functional Team..., DMAIC, SPC, Change Control, Project Management
Education
University of Colorado at Boulder
Ph.D., Biochemical Engineering
University of Colorado at Boulder
M.S., Biochemical Engineering
Virginia Polytechnic Institute and State University
B.S., Chemical Engineering
Parnham, Inc. April 2015 - Present
Vention Medical July 2014 - April 2015
Experien Group April 2013 - July 2014
Nitinol Devices & Components, Inc. October 2009 - April 2013
Parnham, Inc. June 2004 - October 2009
NeuColl June 2000 - May 2004
Skills
Design Control, Start-ups, Design Development, Design Validation, DOE, Process Validation, ISO 14971, FMEA, cGMP, QSR, ISO 13485, V&V, Quality System, GMP, Medical Devices, Design Research, Validation, Pharmaceutical Industry, Product Development, Product Launch, Quality Assurance, Quality Management, Design of Experiments, ISO, CAPA, Quality Control, Manufacturing, Root Cause Analysis, R&D, Commercialization, Testing, Regulatory Submissions, Biomedical Engineering, Process Simulation, Biotechnology, Software Documentation, Clinical Trials, Minitab, Lifesciences, Technology Transfer, Cross-functional Team..., DMAIC, SPC, Change Control, Project Management
Education
University of Colorado at Boulder
Ph.D., Biochemical Engineering
University of Colorado at Boulder
M.S., Biochemical Engineering
Virginia Polytechnic Institute and State University
B.S., Chemical Engineering
Rose Malonzo's Experien Group Experience July 2013 - October 2013
Job Quality Analyst
Industry Medical Devices
Experience
Scanadu May 2015 - Present
ZELTIQ October 2013 - April 2015
Experien Group July 2013 - October 2013
Experien Group February 2010 - June 2013
Experien Group September 2009 - February 2010
Yahoo! April 2009 - July 2009
Adobe Systems Inc. August 2007 - August 2008
Santa Clara University September 2005 - July 2007
Voce Communications July 2006 - June 2007
Santa Clara University September 2004 - June 2005
Skills
Microsoft Office, Customer Service, Editing, Management, Research, Social Networking, Event Planning, Teamwork, Photoshop, Adobe Acrobat, Data Entry, Auditing, Public Speaking, Marketing Communications, OS X, Arena PLM, Document Control, Database Administration, PLM Tools, SAP, Client Services, Mac OS X, Vendor Relations, Document Management, Microsoft Excel, Social Media, Leadership, Microsoft Word, Training
Education
Santa Clara University 2003 — 2007
B.A., Communication
Jesuit High School 1999 — 2003
High School Diploma
Scanadu May 2015 - Present
ZELTIQ October 2013 - April 2015
Experien Group July 2013 - October 2013
Experien Group February 2010 - June 2013
Experien Group September 2009 - February 2010
Yahoo! April 2009 - July 2009
Adobe Systems Inc. August 2007 - August 2008
Santa Clara University September 2005 - July 2007
Voce Communications July 2006 - June 2007
Santa Clara University September 2004 - June 2005
Skills
Microsoft Office, Customer Service, Editing, Management, Research, Social Networking, Event Planning, Teamwork, Photoshop, Adobe Acrobat, Data Entry, Auditing, Public Speaking, Marketing Communications, OS X, Arena PLM, Document Control, Database Administration, PLM Tools, SAP, Client Services, Mac OS X, Vendor Relations, Document Management, Microsoft Excel, Social Media, Leadership, Microsoft Word, Training
Education
Santa Clara University 2003 — 2007
B.A., Communication
Jesuit High School 1999 — 2003
High School Diploma
Kaori Asakawa's Experien Group Experience March 2013 - August 2014
Job Manager, Regulatory Affairs CMC at Intarcia Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Intarcia Therapeutics, Inc. May 2015 - Present
Intarcia Therapeutics August 2014 - May 2015
Experien Group March 2013 - August 2014
Abbott Vascular Devices July 2007 - February 2013
Bio-Rad Laboratories July 2005 - June 2007
Lawrence Berkeley National Laboratory May 2004 - May 2005
UC Berkeley November 2003 - January 2005
Skills
Regulatory Affairs, Regulatory Submissions, Lifesciences, Biotechnology, Medical Devices, Molecular Biology, GMP, Clinical Trials, R&D, Sop, CAPA, Life Sciences
Education
Northeastern University 2008 — 2011
M.S., Regulatory Affairs
University of California, Berkeley 2003 — 2005
B.A., Molecular and Cell Biology
Intarcia Therapeutics, Inc. May 2015 - Present
Intarcia Therapeutics August 2014 - May 2015
Experien Group March 2013 - August 2014
Abbott Vascular Devices July 2007 - February 2013
Bio-Rad Laboratories July 2005 - June 2007
Lawrence Berkeley National Laboratory May 2004 - May 2005
UC Berkeley November 2003 - January 2005
Skills
Regulatory Affairs, Regulatory Submissions, Lifesciences, Biotechnology, Medical Devices, Molecular Biology, GMP, Clinical Trials, R&D, Sop, CAPA, Life Sciences
Education
Northeastern University 2008 — 2011
M.S., Regulatory Affairs
University of California, Berkeley 2003 — 2005
B.A., Molecular and Cell Biology
Katrina Christy's Experien Group Experience October 2007 - Present
Job Director, Clinical and Regulatory Affairs at Experien Group
Industry Medical Devices
Experience
Experien Group October 2007 - Present
AngioDynamics 2002 - 2007
Education
Sonoma State University 1982 — 1986
UC Davis
Experien Group October 2007 - Present
AngioDynamics 2002 - 2007
Education
Sonoma State University 1982 — 1986
UC Davis
Katrina Christy's Experien Group Experience October 2007 - Present
Job Director, Clinical & Regulatory Affairs at Experien Group
Industry Medical Devices
Experience
Experien Group October 2007 - Present
AngioDynamics January 2007 - September 2007
RITA Medical Systems October 2002 - January 2007
Converge Medical May 2000 - September 2002
Heartport, Inc. October 1995 - April 2000
Education
Sonoma State University 1982 — 1987
Bachelors, Biology
Experien Group October 2007 - Present
AngioDynamics January 2007 - September 2007
RITA Medical Systems October 2002 - January 2007
Converge Medical May 2000 - September 2002
Heartport, Inc. October 1995 - April 2000
Education
Sonoma State University 1982 — 1987
Bachelors, Biology
Russ Felkey's Experien Group Experience 2008 - 2011
Job RA/QA Clinical Professional
Industry Medical Devices
Experience
Medtronic, Inc. 2011 - Present
Experien Group 2008 - 2011
EnteroMedics 2005 - 2008
Boston Scientific 2003 - 2005
Medtronic 2002 - 2003
ATS Medical, Inc. 1991 - 2002
Cardiovascular Imaging Systems 1989 - 1991
GV Medical 1984 - 1989
Medtronic 1977 - 1984
Food and Drug Administration 1972 - 1977
Skills
FDA, Regulatory Affairs, Clinical Development, R&D, Clinical Research, PMA, Regulatory Submissions, Medical Devices, Quality Assurance, ISO 13485, Design Control, Biomedical Engineering, CAPA, GLP, Cross-functional Team..., Quality Management, Start-ups, Quality System, Clinical Trials, Clinical Study Design, Neurology
Education
University of Iowa 1970 — 1972
B.S., Chemistry
Medtronic, Inc. 2011 - Present
Experien Group 2008 - 2011
EnteroMedics 2005 - 2008
Boston Scientific 2003 - 2005
Medtronic 2002 - 2003
ATS Medical, Inc. 1991 - 2002
Cardiovascular Imaging Systems 1989 - 1991
GV Medical 1984 - 1989
Medtronic 1977 - 1984
Food and Drug Administration 1972 - 1977
Skills
FDA, Regulatory Affairs, Clinical Development, R&D, Clinical Research, PMA, Regulatory Submissions, Medical Devices, Quality Assurance, ISO 13485, Design Control, Biomedical Engineering, CAPA, GLP, Cross-functional Team..., Quality Management, Start-ups, Quality System, Clinical Trials, Clinical Study Design, Neurology
Education
University of Iowa 1970 — 1972
B.S., Chemistry
Julia Anastas's Experien Group Experience March 2013 - March 2014
Job Director, Regulatory Affairs at PneumRx, Inc., a BTG International group company
Industry Medical Devices
Experience
PneumRx, Inc., a BTG International group company May 2015 - Present
Auxogyn, Inc. March 2014 - April 2015
Experien Group March 2013 - March 2014
J Anastas Consulting January 2013 - March 2013
Vibrynt, Inc. September 2008 - December 2012
Abbott Vascular January 2007 - September 2008
Guidant January 2005 - December 2006
Guidant 2002 - 2004
Cygnus Inc. 1998 - 2002
Chiron Corporation 1994 - 1998
Skills
Medical Devices, FDA, PMA, 501(k), Regulatory Requirements, CE marking, Clinical Trials, Design Control, V&V, Validation, Clinical Development, GCP, Quality System, Technical Writing, 21 CFR, Biotechnology
Education
Boston University
MPH, Public Health
Boston University
BA, Chemistry with Biology Minor
PneumRx, Inc., a BTG International group company May 2015 - Present
Auxogyn, Inc. March 2014 - April 2015
Experien Group March 2013 - March 2014
J Anastas Consulting January 2013 - March 2013
Vibrynt, Inc. September 2008 - December 2012
Abbott Vascular January 2007 - September 2008
Guidant January 2005 - December 2006
Guidant 2002 - 2004
Cygnus Inc. 1998 - 2002
Chiron Corporation 1994 - 1998
Skills
Medical Devices, FDA, PMA, 501(k), Regulatory Requirements, CE marking, Clinical Trials, Design Control, V&V, Validation, Clinical Development, GCP, Quality System, Technical Writing, 21 CFR, Biotechnology
Education
Boston University
MPH, Public Health
Boston University
BA, Chemistry with Biology Minor
Gina Giannini, M.S.'s Experien Group Experience July 2007 - November 2012
Job Regulatory Affairs Specialist II at Stryker Neurovascular
Industry Medical Devices
Experience
Stryker Neurovascular December 2012 - Present
Experien Group July 2007 - November 2012
Skills
Regulatory Affairs, Molecular Biology, FDA, Microbiology, 510 K, IRB, IDE, Microsoft Office, Medical Devices, GCP, Regulatory Submissions, Dermatology, Clinical Development, Therapeutic Areas, Cardiology, Pharmaceutical Industry, ISO 13485, Design Control, Clinical Research, Clinical Trials, PMA, CAPA, CTMS, Clinical Monitoring, Biotechnology, IND, Lifesciences, Protocol, Sop, EDC, CRO, Clinical Data Management, ICH-GCP, Oncology, Quality System, Immunology, Drug Development, Validation, Clinical Operations, Medical Writing, Biologics, Neurology, ISO 14971, GMP, 21 CFR Part 11, Commercialization, V&V, Hardware Diagnostics, Regulatory Requirements, Diabetes
Education
San Jose State University 2004 — 2007
Masters of Science, Microbiology and Molecular Biology
University of San Francisco 1998 — 2002
Bachelors of Science, Biology
Stryker Neurovascular December 2012 - Present
Experien Group July 2007 - November 2012
Skills
Regulatory Affairs, Molecular Biology, FDA, Microbiology, 510 K, IRB, IDE, Microsoft Office, Medical Devices, GCP, Regulatory Submissions, Dermatology, Clinical Development, Therapeutic Areas, Cardiology, Pharmaceutical Industry, ISO 13485, Design Control, Clinical Research, Clinical Trials, PMA, CAPA, CTMS, Clinical Monitoring, Biotechnology, IND, Lifesciences, Protocol, Sop, EDC, CRO, Clinical Data Management, ICH-GCP, Oncology, Quality System, Immunology, Drug Development, Validation, Clinical Operations, Medical Writing, Biologics, Neurology, ISO 14971, GMP, 21 CFR Part 11, Commercialization, V&V, Hardware Diagnostics, Regulatory Requirements, Diabetes
Education
San Jose State University 2004 — 2007
Masters of Science, Microbiology and Molecular Biology
University of San Francisco 1998 — 2002
Bachelors of Science, Biology
Kristin Crosland's Experien Group Experience 2007 - Present
Job Vice President of Business Development at Experien Group
Industry Medical Devices
Experience
Experien Group 2007 - Present
KSC Consulting, LLC 2004 - 2007
Skills
Business Strategy, Business Development, Marketing Strategy, Medical Devices, FDA, Public Policy, Education, Research
Education
University of California, Los Angeles 1998 — 2003
Educational Policy
Duke University 1990 — 1994
BS, Political Science
Experien Group 2007 - Present
KSC Consulting, LLC 2004 - 2007
Skills
Business Strategy, Business Development, Marketing Strategy, Medical Devices, FDA, Public Policy, Education, Research
Education
University of California, Los Angeles 1998 — 2003
Educational Policy
Duke University 1990 — 1994
BS, Political Science
Brad Solberg's Experien Group Experience Clinical Research ManagerMedtronicAugust 2007 - June 2009
Job Medical Devices Professional
Industry Medical Devices
Experience
Experien Group Clinical Research ManagerMedtronicAugust 2007 - June 2009
Abbott Vascular 2004 - 2007
Skills
Clinical Development, Regulatory Affairs, Clinical Research, Medical Devices, FDA, GCP, CTMS, CRO, Regulatory Submissions, EDC, Clinical Monitoring, Life Sciences
Education
San Jose State University
BS, Environmental Studies
Experien Group Clinical Research ManagerMedtronicAugust 2007 - June 2009
Abbott Vascular 2004 - 2007
Skills
Clinical Development, Regulatory Affairs, Clinical Research, Medical Devices, FDA, GCP, CTMS, CRO, Regulatory Submissions, EDC, Clinical Monitoring, Life Sciences
Education
San Jose State University
BS, Environmental Studies
Shruti Jayakumar's Experien Group Experience August 2012 - November 2012
Job Regulatory Affairs Manager
Industry Biotechnology
Experience
ZELTIQ June 2015 - Present
ZELTIQ January 2014 - Present
ZELTIQ December 2012 - December 2013
Experien Group August 2012 - November 2012
Experien Group March 2010 - August 2012
Dr. William Fonzi Candida albicans Lab ǀ Georgetown University January 2009 - August 2009
Dr. Jing Wang Drosophila Lab ǀ University of California October 2005 - August 2006
Skills
Medical Devices, Regulatory Affairs, FDA, Design Control, Regulatory Submissions, CE marking, PMA, CAPA
Education
Georgetown University 2009 — 2009
MS, Microbiology and Immunology
University of California, San Diego 2004 — 2008
BS, Biology
Georgetown University
MS, Microbiology and Immunology
The University of Edinburgh
University of California, Berkeley
BS, Biology
ZELTIQ June 2015 - Present
ZELTIQ January 2014 - Present
ZELTIQ December 2012 - December 2013
Experien Group August 2012 - November 2012
Experien Group March 2010 - August 2012
Dr. William Fonzi Candida albicans Lab ǀ Georgetown University January 2009 - August 2009
Dr. Jing Wang Drosophila Lab ǀ University of California October 2005 - August 2006
Skills
Medical Devices, Regulatory Affairs, FDA, Design Control, Regulatory Submissions, CE marking, PMA, CAPA
Education
Georgetown University 2009 — 2009
MS, Microbiology and Immunology
University of California, San Diego 2004 — 2008
BS, Biology
Georgetown University
MS, Microbiology and Immunology
The University of Edinburgh
University of California, Berkeley
BS, Biology
Laraine Pangelina's Experien Group Experience 2004 - 2006
Job Regulatory Affairs at MicroVention, Inc
Industry Medical Devices
Experience
MicroVention, Inc June 2009 - Present
Concentric Medical 2008 - 2009
Boston Scientific, Neurointerventional Division 2006 - 2008
Experien Group 2004 - 2006
Guidant, Endovascular Solutions 2003 - 2004
Timi3 Systems 2001 - 2003
Oratec Interventions 2000 - 2001
CardioThoracic Systems (CTS) 1997 - 2000
Boston Scientific / Target Therapeutics 1993 - 1997
Advanced Cardiovascular Systems 1984 - 1993
Skills
Medical Devices, FDA, CE marking, ISO 13485, Regulatory Affairs, CAPA, Quality System, PMA, Worldwide Regulatory...
Education
Pomona High
San Francisco State University
Bachelor's degree
MicroVention, Inc June 2009 - Present
Concentric Medical 2008 - 2009
Boston Scientific, Neurointerventional Division 2006 - 2008
Experien Group 2004 - 2006
Guidant, Endovascular Solutions 2003 - 2004
Timi3 Systems 2001 - 2003
Oratec Interventions 2000 - 2001
CardioThoracic Systems (CTS) 1997 - 2000
Boston Scientific / Target Therapeutics 1993 - 1997
Advanced Cardiovascular Systems 1984 - 1993
Skills
Medical Devices, FDA, CE marking, ISO 13485, Regulatory Affairs, CAPA, Quality System, PMA, Worldwide Regulatory...
Education
Pomona High
San Francisco State University
Bachelor's degree
Alexander Roe's Experien Group Experience July 2011 - August 2012
Job Senior Manager, New Business Development at Intuitive Surgical
Industry Medical Devices
Experience
Intuitive Surgical August 2012 - Present
Experien Group July 2011 - August 2012
Experien Group June 2010 - July 2011
Foundation Fighting Blindness January 2007 - August 2008
Foundation Fighting Blindness January 2006 - January 2007
Sanderling Ventures September 2003 - December 2005
Skills
Medical Devices, Due Diligence, Financial Analysis, Strategic Planning, Venture Capital, Corporate Development, New Business Development, Business Development, Start-ups, Strategy, Market Analysis, Mergers, Strategic Partnerships, Market Research, Commercialization, Market Development, Product Launch, Marketing Strategy, Analytics, Valuation, Corporate Finance, Private Equity, Acquisition Integration, Lifesciences, Entrepreneurship, Negotiation, Capital Equipment, IPO, Patents, Licensing, Analysis, Biotechnology, Clinical Development, Financial Modeling, Business Planning, Strategic Thinking, Growth Strategies, Clinical Trials, Marketing, Disposables, Surgical Instruments, Intellectual Property, Technology Transfer, Operating Room, Product Development, Team Motivation
Education
Harvard Business School 2008 — 2010
MBA
Connecticut College 1999 — 2003
B.A., History, English
Georgetown Prep 1995 — 1999
Intuitive Surgical August 2012 - Present
Experien Group July 2011 - August 2012
Experien Group June 2010 - July 2011
Foundation Fighting Blindness January 2007 - August 2008
Foundation Fighting Blindness January 2006 - January 2007
Sanderling Ventures September 2003 - December 2005
Skills
Medical Devices, Due Diligence, Financial Analysis, Strategic Planning, Venture Capital, Corporate Development, New Business Development, Business Development, Start-ups, Strategy, Market Analysis, Mergers, Strategic Partnerships, Market Research, Commercialization, Market Development, Product Launch, Marketing Strategy, Analytics, Valuation, Corporate Finance, Private Equity, Acquisition Integration, Lifesciences, Entrepreneurship, Negotiation, Capital Equipment, IPO, Patents, Licensing, Analysis, Biotechnology, Clinical Development, Financial Modeling, Business Planning, Strategic Thinking, Growth Strategies, Clinical Trials, Marketing, Disposables, Surgical Instruments, Intellectual Property, Technology Transfer, Operating Room, Product Development, Team Motivation
Education
Harvard Business School 2008 — 2010
MBA
Connecticut College 1999 — 2003
B.A., History, English
Georgetown Prep 1995 — 1999
Patricia Le's Experien Group Experience August 2007 - November 2012
Job Regulatory Affairs Specialist at Thermo Fisher Scientific
Industry Medical Devices
Experience
Thermo Fisher Scientific May 2014 - Present
Solta Medical, Inc. January 2013 - April 2014
TRIA Beauty, Inc. November 2012 - January 2013
Experien Group August 2007 - November 2012
Skills
Regulatory Affairs, Medical Devices, Microsoft Office, Quality System, Biotechnology, Clinical Trials, ISO 13485, Regulatory Submissions, ISO 14971, IND, Cross-functional Team..., FDA, Microsoft Excel, Life Sciences, Product Launch, Product Development
Education
University of California, Los Angeles 2005 — 2007
B.A., Psychology
Thermo Fisher Scientific May 2014 - Present
Solta Medical, Inc. January 2013 - April 2014
TRIA Beauty, Inc. November 2012 - January 2013
Experien Group August 2007 - November 2012
Skills
Regulatory Affairs, Medical Devices, Microsoft Office, Quality System, Biotechnology, Clinical Trials, ISO 13485, Regulatory Submissions, ISO 14971, IND, Cross-functional Team..., FDA, Microsoft Excel, Life Sciences, Product Launch, Product Development
Education
University of California, Los Angeles 2005 — 2007
B.A., Psychology
Mazi Kiani's Experien Group Experience September 2010 - August 2013
Job Director of Quality System & Compliance at Siemens Healthcare
Industry Medical Devices
Experience
Siemens Healthcare July 2013 - Present
Experien Group September 2010 - August 2013
Boston Scientific July 2006 - September 2010
Edwards Lifesciences 2004 - 2006
Edwards Lifesciences 2003 - 2004
Fred Hutchinson Cancer Research Center April 2000 - May 2002
Skills
Quality System, FDA, ISO 13485, Design Control, Medical Devices, Validation, ISO 14971, CAPA, Quality Assurance, Regulatory Affairs, Quality Management, V&V, Operational Excellence, Quality Control, GMP, 21 CFR, FDA GMP, Quality Engineering, Six Sigma, Medical Device Directive, Risk Management, Design of Experiments, PMA, CMDCAS, Usability Engineering, Functional Management, Certified Lead Auditor, Design Dossiers &..., Executive Leadership
Education
University of Washington 1997 — 2002
Bachelor's Degree, Chemical Engineering
Cornell University - Johnson Graduate School of Management 2012 — 2013
Executive Leadership, Management
British Standards Institution (BSI) 2011 — 2011
Certified Lead Auditor - ISO 13485 Medical Device Quality Systems
Siemens Healthcare July 2013 - Present
Experien Group September 2010 - August 2013
Boston Scientific July 2006 - September 2010
Edwards Lifesciences 2004 - 2006
Edwards Lifesciences 2003 - 2004
Fred Hutchinson Cancer Research Center April 2000 - May 2002
Skills
Quality System, FDA, ISO 13485, Design Control, Medical Devices, Validation, ISO 14971, CAPA, Quality Assurance, Regulatory Affairs, Quality Management, V&V, Operational Excellence, Quality Control, GMP, 21 CFR, FDA GMP, Quality Engineering, Six Sigma, Medical Device Directive, Risk Management, Design of Experiments, PMA, CMDCAS, Usability Engineering, Functional Management, Certified Lead Auditor, Design Dossiers &..., Executive Leadership
Education
University of Washington 1997 — 2002
Bachelor's Degree, Chemical Engineering
Cornell University - Johnson Graduate School of Management 2012 — 2013
Executive Leadership, Management
British Standards Institution (BSI) 2011 — 2011
Certified Lead Auditor - ISO 13485 Medical Device Quality Systems
Tyler Nikolich's Experien Group Experience May 2015 - Present
Job Production Assistant at University Readers
Industry Medical Devices
Experience
Experien Group May 2015 - Present
University Readers July 2012 - Present
Skills
Matlab, Solidworks, PowerPoint, Microsoft Office, Labview, Microsoft Excel, Microsoft Word, Biomedical Engineering, Research, Minitab, C++
Education
California Polytechnic State University-San Luis Obispo 2010 — 2014
Bachelor of Science (B.S.), Biomedical Engineering
Cathedral Catholic High School 2006 — 2010
Experien Group May 2015 - Present
University Readers July 2012 - Present
Skills
Matlab, Solidworks, PowerPoint, Microsoft Office, Labview, Microsoft Excel, Microsoft Word, Biomedical Engineering, Research, Minitab, C++
Education
California Polytechnic State University-San Luis Obispo 2010 — 2014
Bachelor of Science (B.S.), Biomedical Engineering
Cathedral Catholic High School 2006 — 2010