Director, Human Factors @ (January 2023 - September 2023)
Director Human Factors (Manager Human Factors<Sr. Human Factors Engineer<HF Specialist Contractor) @ (May 2016 - January 2023)
Biomedical Consultant @ Denise Forkey Medical Device Development Solutions (January 2016 - April 2020)
Board Member @ (October 2017 - October 2018)
Sr. Director of Marketing and Corporate Communications @ (October 2014 - January 2016)
Sr Director of Marketing and Client Services @ (March 2013 - October 2014)
Sr Director of Business Development and Regulatory Affairs @ Surpass-Silicon Valley (formerly LyChron, LLC) (January 2013 - March 2013)
Sr. Director of Business Development and Regulatory Affairs Positions @ Surpass-Silicon Valley (formerly LyChron, LLC) (December 2007 - January 2013)
Director of Operations and Regulatory Compliance @ Surpass-Silicon Valley (formerly LyChron, LLC) (May 2003 - December 2007)
Director of Operations and Quality Assurance @ Surpass-Silicon Valley (formerly LyChron, LLC) (January 2002 - May 2003)
Preclinical Engineer thru Project Group Lead Preclinical Research @ (January 1998 - January 2002)
Biomedical Engineering Assistant @ Maven Laboratories (name changed to Woodside Biomedical) (September 1996 - November 1997)
Biomedical Engineering Consultant @ Ergomed (August 1997 - October 1997)
Denise Forkey Education
California State University-Sacramento
Master's degree (Biomedical Engineering)
1993-1998
California Lutheran University
BS (Physics)
1989-1993
Denise Forkey Skills
Biomedical Engineering
Biotechnology
CAPA
CRO
Clinical Development
Clinical Research
Clinical Trials
Commercialization
Cross-functional Team Leadership
Drug Development
FDA
Formative Evaluation
GLP
Good Laboratory Practice (GLP)
Human Factors Engineering
Human Factors Validation
ISO 13485
Interpersonal Relationships
Interventional Cardiology
Laboratory
Life Sciences
Lifesciences
Marketing Communications
Medical Devices
Medical Imaging
Pharmaceutical Industry
Presentations
Product Development
Product Launch
Project Management
Protocol
Quality Assurance
Quality System
R&D
Regulatory Affairs
SEO Copywriting
Social Media Marketing
Sop
Standard Operating Procedure (SOP)
Training Plans
Training Strategy
U.S. Food and Drug Administration (FDA)
Usability Engineering
Usability Testing
Use-related risk analysis
Validation
Vascular
Good Laboratory Practice Glp
Cross Functional Team
Communications
Interventional
Marketing
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Biomedical Engineer
Research
u.s. Food and Drug Administration
Good Laboratory Practice
Denise Forkey Summary
Denise Forkey, based in San Jose, CA, US, is currently a Director, Human Factors Strategy - Advisory at ClariMed, Inc.. Denise Forkey brings experience from previous roles at ClariMed, Inc., UserWise, Inc., Denise Forkey Medical Device Development Solutions and Biomedical Engineering Society. Denise Forkey holds a 1993 - 1998 Master's degree in Biomedical Engineering @ California State University-Sacramento. With a robust skill set that includes Biomedical Engineering, Biotechnology, CAPA, CRO, Clinical Development and more. Denise Forkey has 4 emails and 2 mobile phone numbers on RocketReach.
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