Oraya Therapeutics, Inc.
Industry: Commercial company
DescriptionHeadquarters: Newark, CA Founded: 2006
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Oraya Therapeutics, Inc. Employees
Employee
Years
Job
Industry
Reinhard Pichl Reinhard Pichl's Oraya Therapeutics, Inc. Experience June 2013 - Present
Job bei Oraya Therapeutics
Industry Medical Devices
Experience
Oraya Therapeutics, Inc. June 2013 - Present
Reinhard Pichl Medizinische Dienstleistungen December 2011 - Present
Domilens GmbH March 2010 - November 2011
Domilens November 2007 - May 2010
AMO January 2000 - October 2007
Dentsply September 1994 - December 1999
IONOS 1990 - August 1994
ESPE 1985 - 1990
Skills
Medical Devices, Product Launch, Management, Market Development, Sales, Leadership, Strategy, Gesundheitspflege, Medizinprodukte, Produkteinführung, Healthcare, Marketingstrategie, Marktentwicklung, Strategisches Management, Unternehmensführung, Verkaufsleitung, Vertrieb, Geschäftsführung, Betriebskapital, Abteilungsübergreifende..., Pharmaindustrie, Produktentwicklung, Produktmarketing, Product Marketing, Marketing Strategy
Education
Technische Universität München 1976 — 1986
Dr., Chemie
Gymnasium Mühldorf 1966 — 1975
Abitur
Oraya Therapeutics, Inc. June 2013 - Present
Reinhard Pichl Medizinische Dienstleistungen December 2011 - Present
Domilens GmbH March 2010 - November 2011
Domilens November 2007 - May 2010
AMO January 2000 - October 2007
Dentsply September 1994 - December 1999
IONOS 1990 - August 1994
ESPE 1985 - 1990
Skills
Medical Devices, Product Launch, Management, Market Development, Sales, Leadership, Strategy, Gesundheitspflege, Medizinprodukte, Produkteinführung, Healthcare, Marketingstrategie, Marktentwicklung, Strategisches Management, Unternehmensführung, Verkaufsleitung, Vertrieb, Geschäftsführung, Betriebskapital, Abteilungsübergreifende..., Pharmaindustrie, Produktentwicklung, Produktmarketing, Product Marketing, Marketing Strategy
Education
Technische Universität München 1976 — 1986
Dr., Chemie
Gymnasium Mühldorf 1966 — 1975
Abitur
Renee Kochevar Renee Kochevar's Oraya Therapeutics, Inc. Experience 2008 - 2009
Job Senior Director Clinical Affairs at ZOLL Circulation
Industry Research
Experience
ZOLL Circulation March 2011 - Present
Satiety, Inc. 2009 - January 2012
Oraya Therapeutics, Inc. 2008 - 2009
Broncus Technologies, Inc. 2005 - 2008
St. Jude Medical 2001 - 2004
Skills
Clinical Trials, Clinical Operations, Clinical Affairs, FDA, Medical Devices, ISO 13485, Clinical Research..., Quality Assurance, Clinical Development, Regulatory Affairs, Clinical Research, Validation, Hardware Diagnostics, Start-ups, Biotechnology, CTMS, Design Control, Oncology, Cardiology, Commercialization, R, Biomedical Engineering
Education
Colorado State University
BA, Psychology
Harvard University
Master of Liberal Arts - ALM, Natural Sciences, Medical Anthropology
University of California, San Diego
PhD, Clinical Psychology
University of Colorado at Boulder
BA, Biology
ZOLL Circulation March 2011 - Present
Satiety, Inc. 2009 - January 2012
Oraya Therapeutics, Inc. 2008 - 2009
Broncus Technologies, Inc. 2005 - 2008
St. Jude Medical 2001 - 2004
Skills
Clinical Trials, Clinical Operations, Clinical Affairs, FDA, Medical Devices, ISO 13485, Clinical Research..., Quality Assurance, Clinical Development, Regulatory Affairs, Clinical Research, Validation, Hardware Diagnostics, Start-ups, Biotechnology, CTMS, Design Control, Oncology, Cardiology, Commercialization, R, Biomedical Engineering
Education
Colorado State University
BA, Psychology
Harvard University
Master of Liberal Arts - ALM, Natural Sciences, Medical Anthropology
University of California, San Diego
PhD, Clinical Psychology
University of Colorado at Boulder
BA, Biology
Neil Friedman Neil Friedman's Oraya Therapeutics, Inc. Experience 2008 - Present
Job Cataract and Refractive Surgeon
Industry Medical Practice
Experience
Atia August 2014 - Present
Oculeve Inc. 2012 - Present
Krypton Vision September 2011 - Present
DigiSight 2010 - Present
Oraya Therapeutics, Inc. 2008 - Present
OptiMedica 2007 - Present
CompareNetworks, OphthalmologyWeb 2007 - Present
Mid-Peninsula Ophthalmology Medical Group 2000 - Present
Stanford University School of Medicine 2000 - Present
Pacific Vision Institute November 2010 - December 2014
Skills
Cataract, Ophthalmology, Surgery, Treatment, Surgical Instruments, Clinical Research, Cataract Surgery, Refractive Surgery, Lenses, Medical Education, Board Certified, Medicine, Product Launch, Healthcare, Medical Devices, Clinical Trials, Biotechnology, Lifesciences, Hardware Diagnostics, Healthcare Consulting, Start-ups, FDA, Technology Transfer, Design Control, Medical Writing, Managed Care, Practice Management, Life Sciences
Education
Baylor College of Medicine 1996 — 1997
Fellowship--Cornea and Refractive surgery
New York Eye and Ear Infirmary 1993 — 1996
Ophthalmology Residency
Harvard Medical School 1988 — 1992
MD
Dartmouth College 1984 — 1988
AB, Biochemistry
Atia August 2014 - Present
Oculeve Inc. 2012 - Present
Krypton Vision September 2011 - Present
DigiSight 2010 - Present
Oraya Therapeutics, Inc. 2008 - Present
OptiMedica 2007 - Present
CompareNetworks, OphthalmologyWeb 2007 - Present
Mid-Peninsula Ophthalmology Medical Group 2000 - Present
Stanford University School of Medicine 2000 - Present
Pacific Vision Institute November 2010 - December 2014
Skills
Cataract, Ophthalmology, Surgery, Treatment, Surgical Instruments, Clinical Research, Cataract Surgery, Refractive Surgery, Lenses, Medical Education, Board Certified, Medicine, Product Launch, Healthcare, Medical Devices, Clinical Trials, Biotechnology, Lifesciences, Hardware Diagnostics, Healthcare Consulting, Start-ups, FDA, Technology Transfer, Design Control, Medical Writing, Managed Care, Practice Management, Life Sciences
Education
Baylor College of Medicine 1996 — 1997
Fellowship--Cornea and Refractive surgery
New York Eye and Ear Infirmary 1993 — 1996
Ophthalmology Residency
Harvard Medical School 1988 — 1992
MD
Dartmouth College 1984 — 1988
AB, Biochemistry
Yohan Bouvron Yohan Bouvron's Oraya Therapeutics, Inc. Experience October 2011 - January 2012
Job Corporate Application Engineer at Runtime Design Automation
Industry Computer Software
Experience
Runtime Design Automation July 2013 - Present
ClubSport May 2008 - October 2014
Oraya Therapeutics, Inc. October 2011 - January 2012
Exxact Corporation January 2011 - August 2011
Skills
Fast Learner, Mac, Electronics, French, Swimming, PowerPoint, Microsoft Excel, Windows, Microsoft Word, Microsoft Office, Event Planning, Public Speaking, Spanish, Facebook, Sales, Social Media, Social Media Marketing, Customer Service, Hardware, Social Networking, Teamwork
Education
San Jose State University 2010 — 2012
BS, Computer Engineering along with a Math Minor
Ohlone College 2007 — 2010
AA, GE
Runtime Design Automation July 2013 - Present
ClubSport May 2008 - October 2014
Oraya Therapeutics, Inc. October 2011 - January 2012
Exxact Corporation January 2011 - August 2011
Skills
Fast Learner, Mac, Electronics, French, Swimming, PowerPoint, Microsoft Excel, Windows, Microsoft Word, Microsoft Office, Event Planning, Public Speaking, Spanish, Facebook, Sales, Social Media, Social Media Marketing, Customer Service, Hardware, Social Networking, Teamwork
Education
San Jose State University 2010 — 2012
BS, Computer Engineering along with a Math Minor
Ohlone College 2007 — 2010
AA, GE
Stephan Buttron Stephan Buttron's Oraya Therapeutics, Inc. Experience 2010 - 2011
Job RA/QA Strategic Consulting
Industry Medical Devices
Experience
NSAI Inc. 2010 - Present
Buttron Consulting October 2008 - Present
Oraya Therapeutics, Inc. 2010 - 2011
BSI 2009 - 2009
HALT Medical Inc. 2007 - 2009
Kyphon Inc. 2007 - 2007
SpineVision Inc. 2007 - 2007
St. Francis Medical Technologies 2005 - 2007
med unlimited GmbH 1999 - 2007
Conceptus Inc. 2004 - 2005
Skills
ISO 13485, FDA, Medical Devices, Quality System, Quality Assurance, PMA, CAPA, Design Control, 21 CFR, Validation, CE marking, Regulatory Affairs, Medical Device Directive, ISO 14971, V&V
Education
University of Applied Sciences Hamburg-Bergedorf 1983 — 1987
Dipl. Ing. (B.S.), Biomedical Engineering
The University of Göttingen 1981 — 1983
Social Science
Gymnasium an der Willmsstrasse
NSAI Inc. 2010 - Present
Buttron Consulting October 2008 - Present
Oraya Therapeutics, Inc. 2010 - 2011
BSI 2009 - 2009
HALT Medical Inc. 2007 - 2009
Kyphon Inc. 2007 - 2007
SpineVision Inc. 2007 - 2007
St. Francis Medical Technologies 2005 - 2007
med unlimited GmbH 1999 - 2007
Conceptus Inc. 2004 - 2005
Skills
ISO 13485, FDA, Medical Devices, Quality System, Quality Assurance, PMA, CAPA, Design Control, 21 CFR, Validation, CE marking, Regulatory Affairs, Medical Device Directive, ISO 14971, V&V
Education
University of Applied Sciences Hamburg-Bergedorf 1983 — 1987
Dipl. Ing. (B.S.), Biomedical Engineering
The University of Göttingen 1981 — 1983
Social Science
Gymnasium an der Willmsstrasse
E. Mark Shusterman, MD E. Mark Shusterman, MD's Oraya Therapeutics, Inc. Experience June 2007 - Present
Job Experienced Leader in Medical Technology Innovation
Industry Medical Devices
Experience
Mazda Raceway Laguna Seca May 2015 - Present
Cerebrotech Medical Systems, Inc. November 2013 - Present
Oraya Therapeutics, Inc. June 2007 - Present
Interorbital Systems April 2008 - Present
USAF Reserve July 1995 - Present
Skills
Clinical Research, Clinical Trials, Product Development, Program Management, Commercialization, Protocol, Clinical Development, Project Planning, Regulations, Mergers, Strategy, Due Diligence, Sourcing, Medical Devices, Board Relations, Healthcare, Medicine, Biotechnology, Hospitals, Lifesciences, FDA, Product Launch, Start-ups, Mergers & Acquisitions, Strategic Planning, EMR, Informatics, Leadership, Medical Education, Surgery, Ophthalmology, Training, Treatment, Product Marketing, Life Sciences
Education
University of Rochester School of Medicine and Dentistry 1990 — 1994
M.D.
University of Rochester 1985 — 1989
B.A.
University of Rochester 1989 — 1990
Certificate
USAF Air University 2010 — 2013
USAF Air University 1999 — 2000
USAF School of Aerospace Medicine 1996 — 1996
Certificate
関西外国語大学 1989 — 1989
Brighton High School 1981 — 1985
Diploma
Mazda Raceway Laguna Seca May 2015 - Present
Cerebrotech Medical Systems, Inc. November 2013 - Present
Oraya Therapeutics, Inc. June 2007 - Present
Interorbital Systems April 2008 - Present
USAF Reserve July 1995 - Present
Skills
Clinical Research, Clinical Trials, Product Development, Program Management, Commercialization, Protocol, Clinical Development, Project Planning, Regulations, Mergers, Strategy, Due Diligence, Sourcing, Medical Devices, Board Relations, Healthcare, Medicine, Biotechnology, Hospitals, Lifesciences, FDA, Product Launch, Start-ups, Mergers & Acquisitions, Strategic Planning, EMR, Informatics, Leadership, Medical Education, Surgery, Ophthalmology, Training, Treatment, Product Marketing, Life Sciences
Education
University of Rochester School of Medicine and Dentistry 1990 — 1994
M.D.
University of Rochester 1985 — 1989
B.A.
University of Rochester 1989 — 1990
Certificate
USAF Air University 2010 — 2013
USAF Air University 1999 — 2000
USAF School of Aerospace Medicine 1996 — 1996
Certificate
関西外国語大学 1989 — 1989
Brighton High School 1981 — 1985
Diploma
Darius M. Moshfeghi's Oraya Therapeutics, Inc. Experience 2007 - 2014
Job Professor, Ophthalmology, Vitreoretinal Surgery, Stanford University School of Medicine
Industry Medical Practice
Experience
Stanford University School of Medicine 2002 - Present
InSitu Therapeutics, Inc. 2007 - Present
Oraya Therapeutics, Inc. 2007 - 2014
MyWhiteCoat.com, Realm Global, LLC 2008 - 2012
OcuBell 2009 - 2011
Compare Networks, Inc., Ophthalmology Web 2007 - 2008
Skills
Surgery, Medical Imaging, Clinical Trials, Medical Devices, Biotechnology, Biomedical Engineering, Clinical Research, Telemedicine, Oncology, Medical Education, Hardware Diagnostics, Clinical Development, FDA, Ophthalmology, Healthcare, Pediatrics, Cardiology, Lifesciences, Neuroscience, Medicine, Board Certified, Infectious Diseases, Hospitals, Cancer, R&D, Immunology, Commercialization, Informatics, Treatment, Drug Development
Education
Cole Eye Institute, Cleveland Clinic Foundation 2000 — 2002
Fellowship, Vitreoretinal Surgery
The University of Tennessee Health Science Center 1999 — 2000
Fellowship, Ocular Oncology & Orbital Disease
Tulane University School of Medicine 1996 — 1999
Residency, Ophthalmology
Tulane University School of Medicine 1995 — 1996
Internship, Transitional Medicine
Tulane University School of Medicine 1991 — 1995
MD, Medicine
Tulane University 1987 — 1991
B.S.Eng, Biomedical Engineering
Stanford University School of Medicine 2002 - Present
InSitu Therapeutics, Inc. 2007 - Present
Oraya Therapeutics, Inc. 2007 - 2014
MyWhiteCoat.com, Realm Global, LLC 2008 - 2012
OcuBell 2009 - 2011
Compare Networks, Inc., Ophthalmology Web 2007 - 2008
Skills
Surgery, Medical Imaging, Clinical Trials, Medical Devices, Biotechnology, Biomedical Engineering, Clinical Research, Telemedicine, Oncology, Medical Education, Hardware Diagnostics, Clinical Development, FDA, Ophthalmology, Healthcare, Pediatrics, Cardiology, Lifesciences, Neuroscience, Medicine, Board Certified, Infectious Diseases, Hospitals, Cancer, R&D, Immunology, Commercialization, Informatics, Treatment, Drug Development
Education
Cole Eye Institute, Cleveland Clinic Foundation 2000 — 2002
Fellowship, Vitreoretinal Surgery
The University of Tennessee Health Science Center 1999 — 2000
Fellowship, Ocular Oncology & Orbital Disease
Tulane University School of Medicine 1996 — 1999
Residency, Ophthalmology
Tulane University School of Medicine 1995 — 1996
Internship, Transitional Medicine
Tulane University School of Medicine 1991 — 1995
MD, Medicine
Tulane University 1987 — 1991
B.S.Eng, Biomedical Engineering
Steve Jwanouskos Steve Jwanouskos's Oraya Therapeutics, Inc. Experience 2008 - 2009
Job Medical Device Expert Consultant
Industry Medical Devices
Experience
Abbott Medical Optics August 2013 - Present
OptiMedica Corporation October 2011 - Present
4308 Silva Avenue March 2012 - March 2013
KKUP 1992 - 2010
Oraya Therapeutics, Inc. 2008 - 2009
ReVasular Therapeutics (acquired by Bosoton Scientific, 2011) 2007 - 2009
SpineAlign Medical 2007 - 2009
Stellartech Research 2006 - 2009
Marubeni 2008 - 2008
Allux Medical Technologies, Inc. (Menlo Park, CA) February 2005 - June 2006
Skills
Orthopedic, Combination Products, Medical Devices, Radiation Therapy, FDA, Design Control, ISO 13485, Regulatory Affairs, CAPA, Quality System, Clinical Research, Clinical Trials, R&D, Cardiology, V&V, Cross-functional Team..., PMA, Quality Assurance, GMP, Validation, Regulatory Submissions, CE marking, Biotechnology, Biomedical Engineering, ISO 14971, Lifesciences, Hardware Diagnostics, Commercialization, Product Launch, Clinical Development, 21 CFR Part 11, Oncology, Pharmaceutical Industry, Regulatory Requirements, Clinical Monitoring, Ophthalmology, GLP, Quality Auditing, Sop, Life Sciences, GCP
Education
University of Minnesota-Twin Cities 1981 — 1989
Bachelor of Science, Rhetoric (Scientific and Technical Writing and Editing)
Abbott Medical Optics August 2013 - Present
OptiMedica Corporation October 2011 - Present
4308 Silva Avenue March 2012 - March 2013
KKUP 1992 - 2010
Oraya Therapeutics, Inc. 2008 - 2009
ReVasular Therapeutics (acquired by Bosoton Scientific, 2011) 2007 - 2009
SpineAlign Medical 2007 - 2009
Stellartech Research 2006 - 2009
Marubeni 2008 - 2008
Allux Medical Technologies, Inc. (Menlo Park, CA) February 2005 - June 2006
Skills
Orthopedic, Combination Products, Medical Devices, Radiation Therapy, FDA, Design Control, ISO 13485, Regulatory Affairs, CAPA, Quality System, Clinical Research, Clinical Trials, R&D, Cardiology, V&V, Cross-functional Team..., PMA, Quality Assurance, GMP, Validation, Regulatory Submissions, CE marking, Biotechnology, Biomedical Engineering, ISO 14971, Lifesciences, Hardware Diagnostics, Commercialization, Product Launch, Clinical Development, 21 CFR Part 11, Oncology, Pharmaceutical Industry, Regulatory Requirements, Clinical Monitoring, Ophthalmology, GLP, Quality Auditing, Sop, Life Sciences, GCP
Education
University of Minnesota-Twin Cities 1981 — 1989
Bachelor of Science, Rhetoric (Scientific and Technical Writing and Editing)
Catherine (Katey) Casab, MS, BSCS, CMQ/OE, CSQE, CQA Catherine (Katey) Casab, MS, BSCS, CMQ/OE, CSQE, CQA's Oraya Therapeutics, Inc. Experience September 2008 - January 2009
Job Manager, SWQA at Complete Genomics Inc.
Industry Medical Devices
Experience
Complete Genomics Inc.Curren January 2014 - Present
Palmaz Scientific August 2013 - January 2014
Hansen Medical March 2010 - August 2013
Velomedix October 2007 - March 2011
Santur Inc. - Part time contract October 2009 - November 2009
Oraya Therapeutics, Inc. September 2008 - January 2009
Tyco Healthcare January 2006 - July 2007
The EmTek Group April 2004 - December 2005
Revivant 2001 - 2003
Symphonix 1999 - 2001
Skills
FDA, ISO 13485, Medical Devices, Quality Assurance, Design Control, Validation, 21 CFR Part 11, Product Development, Project Management, Quality System, CAPA, Design of Experiments, Manufacturing, Quality Management, Team Management, ISO, GMP, Cross-functional Team..., CSQE, ISO 14001, Risk Management, CQA, Software Documentation, Sop, Biomedical Engineering, Quality Auditing, IEC / AAMI 62304:2006, Verification, Medical Device DHF, Risk Management File..., Risk Management Report..., Core Team Verification..., DHF - Design History..., System Verification..., Software Risk Analysis, ASQ Senior Member, ASQ Certified Manager..., V&V, SOP
Education
SUNY Polytechnic Institute 1991 — 1999
M.S.
SUNY Polytechnic Institute 1984 — 1988
B.S.
Mohawk Valley Community College 1983 — 1984
A.A.S.
Oneida County BOCES 1973 — 1975
Diploma
Whitesboro Sr. High School, Marcy 1972 — 1975
Diploma
Complete Genomics Inc.Curren January 2014 - Present
Palmaz Scientific August 2013 - January 2014
Hansen Medical March 2010 - August 2013
Velomedix October 2007 - March 2011
Santur Inc. - Part time contract October 2009 - November 2009
Oraya Therapeutics, Inc. September 2008 - January 2009
Tyco Healthcare January 2006 - July 2007
The EmTek Group April 2004 - December 2005
Revivant 2001 - 2003
Symphonix 1999 - 2001
Skills
FDA, ISO 13485, Medical Devices, Quality Assurance, Design Control, Validation, 21 CFR Part 11, Product Development, Project Management, Quality System, CAPA, Design of Experiments, Manufacturing, Quality Management, Team Management, ISO, GMP, Cross-functional Team..., CSQE, ISO 14001, Risk Management, CQA, Software Documentation, Sop, Biomedical Engineering, Quality Auditing, IEC / AAMI 62304:2006, Verification, Medical Device DHF, Risk Management File..., Risk Management Report..., Core Team Verification..., DHF - Design History..., System Verification..., Software Risk Analysis, ASQ Senior Member, ASQ Certified Manager..., V&V, SOP
Education
SUNY Polytechnic Institute 1991 — 1999
M.S.
SUNY Polytechnic Institute 1984 — 1988
B.S.
Mohawk Valley Community College 1983 — 1984
A.A.S.
Oneida County BOCES 1973 — 1975
Diploma
Whitesboro Sr. High School, Marcy 1972 — 1975
Diploma
Barbara Price's Oraya Therapeutics, Inc. Experience August 2009 - Present
Job Materials Manager at Oraya Therapeutics, Inc.
Industry Medical Devices
Experience
Oraya Therapeutics, Inc. August 2009 - Present
KLA-Tencor March 2007 - May 2009
Therma-Wave (Now KLA-Tencor) January 2000 - March 2007
Etec Systems (Now Applied Materials) 1979 - 2003
Skills
MRP, Supply Management, Materials Management, Master Scheduling, Process Improvement, Electronics, Procurement, Analysis, Manufacturing, Product Development, SAP, Materials, Supply Chain Management, Purchasing, Strategic Sourcing, Logistics, SPC, Engineering Management, Global Sourcing, Outsourcing, Semiconductors, Production Planning, Demand Planning, Strategic Planning, Project Planning, Supply Chain, Engineering, Supply Chain..., Contract Manufacturing, ISO 13485, Supplier Quality, APICS
Education
APICS /In-House Training at Etec Systems
APICS Studies
California State University-Hayward
Purchasing and Materials Management
Karrass; Negotiating Seminars
Contract Negotiations
Phil Crosby Quality Classes (QES)
Purchasing Management Asso. of Silicon Valley
Certificate, "Buyer and the Law"
Santa Clara University
Legal Aspects of Purchasing
Worldwide Flow College
Certificate, Demand Flow Technology
Oraya Therapeutics, Inc. August 2009 - Present
KLA-Tencor March 2007 - May 2009
Therma-Wave (Now KLA-Tencor) January 2000 - March 2007
Etec Systems (Now Applied Materials) 1979 - 2003
Skills
MRP, Supply Management, Materials Management, Master Scheduling, Process Improvement, Electronics, Procurement, Analysis, Manufacturing, Product Development, SAP, Materials, Supply Chain Management, Purchasing, Strategic Sourcing, Logistics, SPC, Engineering Management, Global Sourcing, Outsourcing, Semiconductors, Production Planning, Demand Planning, Strategic Planning, Project Planning, Supply Chain, Engineering, Supply Chain..., Contract Manufacturing, ISO 13485, Supplier Quality, APICS
Education
APICS /In-House Training at Etec Systems
APICS Studies
California State University-Hayward
Purchasing and Materials Management
Karrass; Negotiating Seminars
Contract Negotiations
Phil Crosby Quality Classes (QES)
Purchasing Management Asso. of Silicon Valley
Certificate, "Buyer and the Law"
Santa Clara University
Legal Aspects of Purchasing
Worldwide Flow College
Certificate, Demand Flow Technology
Bob Delavan Bob Delavan's Oraya Therapeutics, Inc. Experience May 2013 - June 2013
Job Radiation Therapist at Advanced Rad Solutions
Industry Hospital & Health Care
Experience
Advanced Rad Solutions July 2013 - June 2015
Oraya Therapeutics, Inc. May 2013 - June 2013
Sutter Memorial Hospital April 2009 - February 2012
Club Staffing April 2008 - July 2008
Skills
Radiation Therapy, CT simulation, Hospitals, IGRT, ARRT, Brachytherapy, Healthcare Management, Patient Safety, Radiation Safety, Cancer Treatment, BLS, Stereotactic..., Quality Patient Care, EMR, Healthcare, Radiology, Treatment, Dosimetry, Cancer, X-ray, Medical Imaging
Education
California State University-Long Beach 1997 — 1998
B.S., Health Sciences/Radiation Therapy
Advanced Rad Solutions July 2013 - June 2015
Oraya Therapeutics, Inc. May 2013 - June 2013
Sutter Memorial Hospital April 2009 - February 2012
Club Staffing April 2008 - July 2008
Skills
Radiation Therapy, CT simulation, Hospitals, IGRT, ARRT, Brachytherapy, Healthcare Management, Patient Safety, Radiation Safety, Cancer Treatment, BLS, Stereotactic..., Quality Patient Care, EMR, Healthcare, Radiology, Treatment, Dosimetry, Cancer, X-ray, Medical Imaging
Education
California State University-Long Beach 1997 — 1998
B.S., Health Sciences/Radiation Therapy
Fatima Seedat Fatima Seedat's Oraya Therapeutics, Inc. Experience May 2009 - March 2014
Job Executive Assistant at Tegile Systems
Industry Medical Devices
Experience
Tegile Systems February 2014 - Present
Oraya Therapeutics, Inc. May 2009 - March 2014
Scholastic 2002 - 2002
Skills
Medical Devices, Office Administration, Microsoft Office, Visio, Event Planning, FDA, Management, Healthcare, PowerPoint, Account Management, Start-ups, Project Management, Microsoft Excel, Quality Assurance, Cross-functional Team..., Sales Operations, Sales, Customer Service, Leadership, Product Management, SaaS
Education
Chabot College
University of South Africa/Universiteit van Suid-Afrika
Bachelor of Education (B.Ed.), Early Childhood Education and Teaching
Tegile Systems February 2014 - Present
Oraya Therapeutics, Inc. May 2009 - March 2014
Scholastic 2002 - 2002
Skills
Medical Devices, Office Administration, Microsoft Office, Visio, Event Planning, FDA, Management, Healthcare, PowerPoint, Account Management, Start-ups, Project Management, Microsoft Excel, Quality Assurance, Cross-functional Team..., Sales Operations, Sales, Customer Service, Leadership, Product Management, SaaS
Education
Chabot College
University of South Africa/Universiteit van Suid-Afrika
Bachelor of Education (B.Ed.), Early Childhood Education and Teaching
Justin Hanlon Justin Hanlon's Oraya Therapeutics, Inc. Experience March 2012 - Present
Job Medical Physicist at Oraya Therapeutics, Inc.
Industry Medical Devices
Experience
Oraya Therapeutics, Inc. March 2012 - Present
Oraya Therapeutics, Inc. October 2010 - March 2012
University of Florida August 2007 - August 2010
Rensselaer Polytechnic Institute January 2007 - May 2007
Rensselaer Polytechnic Institute September 2006 - December 2006
Rensselaer Polytechnic Institute May 2005 - April 2006
Skills
Medical Devices, Medical Physics, Biomedical Engineering, Image Analysis, Medical Imaging, Dosimetry, MCNP, Design of Experiments, Technical Writing, Technical Documentation, Clinical Support, Physics, Radiation Safety, Radiation Therapy, X-ray, Radiation, Monte Carlo Simulation, Image Processing, Digital Imaging, MRI, Nuclear Medicine, Brachytherapy, Ultrasound, Hardware Diagnostics, Matlab
Education
University of Florida
PhD, Medical Physics
Rensselaer Polytechnic Institute
B.S., Nuclear Engineering and Engineering Physics
Oraya Therapeutics, Inc. March 2012 - Present
Oraya Therapeutics, Inc. October 2010 - March 2012
University of Florida August 2007 - August 2010
Rensselaer Polytechnic Institute January 2007 - May 2007
Rensselaer Polytechnic Institute September 2006 - December 2006
Rensselaer Polytechnic Institute May 2005 - April 2006
Skills
Medical Devices, Medical Physics, Biomedical Engineering, Image Analysis, Medical Imaging, Dosimetry, MCNP, Design of Experiments, Technical Writing, Technical Documentation, Clinical Support, Physics, Radiation Safety, Radiation Therapy, X-ray, Radiation, Monte Carlo Simulation, Image Processing, Digital Imaging, MRI, Nuclear Medicine, Brachytherapy, Ultrasound, Hardware Diagnostics, Matlab
Education
University of Florida
PhD, Medical Physics
Rensselaer Polytechnic Institute
B.S., Nuclear Engineering and Engineering Physics
Yasser A Sowb, PhD's Oraya Therapeutics, Inc. Experience 2008 - 2009
Job Founder at Medical Human Factors
Industry Medical Devices
Experience
Medical Human Factors August 2004 - Present
St Jude Medical, Inc May 2010 - Present
Ventalis, Inc. September 2008 - May 2010
Modulus, Inc. August 2007 - May 2010
Spinal Modulation, Inc January 2008 - March 2010
EPIC Research and Diagnostics June 2008 - January 2010
Autonomic Technologies August 2008 - April 2009
Oraya Therapeutics, Inc. 2008 - 2009
SoundCure 2008 - 2009
IntraPace, Inc. March 2005 - 2008
Skills
Medical Devices, Usability Testing, Human Factors, Human Factors..., Clinical Research, Usability, ISO 13485, User Interface Design, Embedded Systems, Design Control, Simulations, ISO 14971, Biomedical Engineering, Contextual Inquiry, Task Analysis
Education
Stanford University 1997 — 1999
Post-Doctoral Fellow, Human Factors, Medical Instrumentation Design, User-Interface and Decision-Support Systems Design.
University of California, Davis 1995 — 1999
PhD, Biomedical Engineering and Human Factors
California State University-Sacramento 1991 — 1994
MS, Biomedical Engineering and Human Factors
Louisiana State University 1985 — 1990
BS, Electrical & Electronics Engineering
Medical Human Factors August 2004 - Present
St Jude Medical, Inc May 2010 - Present
Ventalis, Inc. September 2008 - May 2010
Modulus, Inc. August 2007 - May 2010
Spinal Modulation, Inc January 2008 - March 2010
EPIC Research and Diagnostics June 2008 - January 2010
Autonomic Technologies August 2008 - April 2009
Oraya Therapeutics, Inc. 2008 - 2009
SoundCure 2008 - 2009
IntraPace, Inc. March 2005 - 2008
Skills
Medical Devices, Usability Testing, Human Factors, Human Factors..., Clinical Research, Usability, ISO 13485, User Interface Design, Embedded Systems, Design Control, Simulations, ISO 14971, Biomedical Engineering, Contextual Inquiry, Task Analysis
Education
Stanford University 1997 — 1999
Post-Doctoral Fellow, Human Factors, Medical Instrumentation Design, User-Interface and Decision-Support Systems Design.
University of California, Davis 1995 — 1999
PhD, Biomedical Engineering and Human Factors
California State University-Sacramento 1991 — 1994
MS, Biomedical Engineering and Human Factors
Louisiana State University 1985 — 1990
BS, Electrical & Electronics Engineering
Thomas Prudent's Oraya Therapeutics, Inc. Experience April 2012 - September 2012
Job Sr. Quality Engineer at Creganna Medical
Industry Medical Devices
Experience
Creganna Medical November 2014 - Present
Clarity Medical Systems, Inc. August 2013 - September 2014
Aptus Endosystems September 2012 - August 2013
Oraya Therapeutics, Inc. April 2012 - September 2012
Thoratec July 2011 - April 2012
Solta Medical, Inc. March 2009 - June 2011
Solta Medical, Inc. September 2006 - June 2011
Cytyc Surgical Products March 2006 - September 2006
Boston Scientific Corporation September 2002 - March 2006
Aerogen, Inc. July 2001 - July 2002
Skills
ISO 13485, Design Control, Medical Devices, FDA, CAPA, Quality Assurance, FMEA, V&V, SPC, ISO 14971, Root Cause Analysis, Supplier Quality, GMP, Biomedical Engineering, Project Management, Sterilization, Quality Engineering, Quality Systems, Product Development, Quality Management, Statistics, Process Validation, Risk Management, Microsoft Office, Start-ups, cGMP, Operations Management, NCMR, Financial Management, IQ/OQ/PQ, Medical Device Directive, Technical Files, Regulatory Compliance..., Design History Files, Biocompatibility, Product Bioburden, R&D, Regulatory Affairs, Manufacturing, MDD, Quality Control, Quality System, Validation, Design of Experiments, Design for Manufacturing, Cross-functional Team..., Testing
Education
California State University-Hayward - School of Business and Economics 2002 — 2005
Master of Business Administration (M.B.A.), Operations and Materials Management & Financial Management
California State University-Fullerton
Master’s Degree, Mechanical Engineering
University of Wisconsin-Madison
Bachelor’s Degree, Mechanical Engineering
Creganna Medical November 2014 - Present
Clarity Medical Systems, Inc. August 2013 - September 2014
Aptus Endosystems September 2012 - August 2013
Oraya Therapeutics, Inc. April 2012 - September 2012
Thoratec July 2011 - April 2012
Solta Medical, Inc. March 2009 - June 2011
Solta Medical, Inc. September 2006 - June 2011
Cytyc Surgical Products March 2006 - September 2006
Boston Scientific Corporation September 2002 - March 2006
Aerogen, Inc. July 2001 - July 2002
Skills
ISO 13485, Design Control, Medical Devices, FDA, CAPA, Quality Assurance, FMEA, V&V, SPC, ISO 14971, Root Cause Analysis, Supplier Quality, GMP, Biomedical Engineering, Project Management, Sterilization, Quality Engineering, Quality Systems, Product Development, Quality Management, Statistics, Process Validation, Risk Management, Microsoft Office, Start-ups, cGMP, Operations Management, NCMR, Financial Management, IQ/OQ/PQ, Medical Device Directive, Technical Files, Regulatory Compliance..., Design History Files, Biocompatibility, Product Bioburden, R&D, Regulatory Affairs, Manufacturing, MDD, Quality Control, Quality System, Validation, Design of Experiments, Design for Manufacturing, Cross-functional Team..., Testing
Education
California State University-Hayward - School of Business and Economics 2002 — 2005
Master of Business Administration (M.B.A.), Operations and Materials Management & Financial Management
California State University-Fullerton
Master’s Degree, Mechanical Engineering
University of Wisconsin-Madison
Bachelor’s Degree, Mechanical Engineering
Kristine Curtiss's Oraya Therapeutics, Inc. Experience March 2009 - June 2011
Job Executive Director, Clinical Operations at PanOptica, Inc.
Industry Pharmaceuticals
Experience
PanOptica, Inc. June 2011 - Present
Oraya Therapeutics, Inc. March 2009 - June 2011
Opko Health, Inc. December 2006 - February 2009
OSI Eyetech August 2000 - 2006
Hoffmann-La Roche 1991 - 2000
Skills
Clinical Trials, Biotechnology, Clinical Supervision, Clinical Development, Clinical Monitoring, Pharmaceutical Industry, Medical Devices, Regulatory Affairs, FDA, Ophthalmology, Clinical Research, Oncology, Clinical Operations, Therapeutic Areas, GCP, CRO
Education
University of Delaware 1989 — 1991
BS, Chemistry
PanOptica, Inc. June 2011 - Present
Oraya Therapeutics, Inc. March 2009 - June 2011
Opko Health, Inc. December 2006 - February 2009
OSI Eyetech August 2000 - 2006
Hoffmann-La Roche 1991 - 2000
Skills
Clinical Trials, Biotechnology, Clinical Supervision, Clinical Development, Clinical Monitoring, Pharmaceutical Industry, Medical Devices, Regulatory Affairs, FDA, Ophthalmology, Clinical Research, Oncology, Clinical Operations, Therapeutic Areas, GCP, CRO
Education
University of Delaware 1989 — 1991
BS, Chemistry
Kristine Curtiss's Oraya Therapeutics, Inc. Experience February 2009 - Present
Job Director, Clinical Affairs at Oraya Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Oraya Therapeutics, Inc. February 2009 - Present
Opko Health December 2006 - February 2009
Eyetech 2000 - 2006
(OSI)eyetech Pharmaceuticals 2000 - 2006
Hoffmann-La Roche 1991 - 2000
Education
University of Delaware 1988 — 1991
Oraya Therapeutics, Inc. February 2009 - Present
Opko Health December 2006 - February 2009
Eyetech 2000 - 2006
(OSI)eyetech Pharmaceuticals 2000 - 2006
Hoffmann-La Roche 1991 - 2000
Education
University of Delaware 1988 — 1991
Jennifer Cerami's Oraya Therapeutics, Inc. Experience April 2010 - Present
Job JC Consulting, LLC
Industry Pharmaceuticals
Experience
Tyrogenex May 2014 - Present
PanOptica September 2013 - Present
Oraya Therapeutics, Inc. April 2010 - Present
JC Consulting, LLC March 2010 - Present
Opko Health Inc April 2007 - July 2009
Celgene October 2006 - March 2007
Eyetech 2004 - 2006
Skills
Quality Assurance, Clinical Development, Medical Devices, EDC, Lifesciences, ICH-GCP
Education
Rutgers University-New Brunswick 2002 — 2004
MA, Cognitive Psychology
College of the Holy Cross 1998 — 2002
Bachelor's degree, Psychology
Tyrogenex May 2014 - Present
PanOptica September 2013 - Present
Oraya Therapeutics, Inc. April 2010 - Present
JC Consulting, LLC March 2010 - Present
Opko Health Inc April 2007 - July 2009
Celgene October 2006 - March 2007
Eyetech 2004 - 2006
Skills
Quality Assurance, Clinical Development, Medical Devices, EDC, Lifesciences, ICH-GCP
Education
Rutgers University-New Brunswick 2002 — 2004
MA, Cognitive Psychology
College of the Holy Cross 1998 — 2002
Bachelor's degree, Psychology
Jackie Ferreira's Oraya Therapeutics, Inc. Experience August 2011 - Present
Job Sr. Director of Communications
Industry Medical Devices
Experience
Oraya Therapeutics, Inc. August 2011 - Present
Carl Zeiss 2004 - 2011
Acuson Corporation, Now Siemens Medical 2000 - 2004
Acuson 1995 - 2000
Skills
Global Communications, Strategic Communications, Corporate Communications, Product Launches, Marketing Communications, Medical Devices, Integrated Marketing, Product Launch, Strategy, Brand Management, Internal Communications, Product Marketing, Marketing Strategy, Marketing Management, Cross-functional Team..., Business Strategy, Market Research, Management, Product Development, Start-ups, Market Planning, Social Media Marketing, Marketing, Strategic Planning, Trade Shows, New Business Development, Competitive Analysis, Healthcare, Digital Marketing, Public Relations, Capital Equipment, Business Development, Strategic Partnerships, Product Management, Medical Imaging, Market Development, B2B
Education
University of Phoenix 1994 — 1997
New York Eye and Ear - Ultrasound Certificate
Oraya Therapeutics, Inc. August 2011 - Present
Carl Zeiss 2004 - 2011
Acuson Corporation, Now Siemens Medical 2000 - 2004
Acuson 1995 - 2000
Skills
Global Communications, Strategic Communications, Corporate Communications, Product Launches, Marketing Communications, Medical Devices, Integrated Marketing, Product Launch, Strategy, Brand Management, Internal Communications, Product Marketing, Marketing Strategy, Marketing Management, Cross-functional Team..., Business Strategy, Market Research, Management, Product Development, Start-ups, Market Planning, Social Media Marketing, Marketing, Strategic Planning, Trade Shows, New Business Development, Competitive Analysis, Healthcare, Digital Marketing, Public Relations, Capital Equipment, Business Development, Strategic Partnerships, Product Management, Medical Imaging, Market Development, B2B
Education
University of Phoenix 1994 — 1997
New York Eye and Ear - Ultrasound Certificate
Mark Arnoldussen's Oraya Therapeutics, Inc. Experience August 2014 - Present
Job Director, Research and Development at Oraya Therapeutics, Inc.
Industry Medical Devices
Experience
Oraya Therapeutics, Inc. August 2014 - Present
Oraya Therapeutics, Inc. 2012 - Present
Oraya Therapeutics, Inc. 2008 - 2012
Oraya Therapeutics, Inc. April 2007 - 2008
Advanced Medical Optics 2006 - April 2007
VISX 2003 - 2006
VISX October 2001 - 2003
Cedars-Sinai Medical Center 1996 - 2001
Skills
Medical Devices, Commercialization, Clinical Data, Clinical Trial Analysis, Clinical Workflow, Technical Marketing, Clinical Support, Matlab, Clinical Training, Marketing Support, Zemax, C++, Labview, Microsoft Office, Microsoft Excel, Photoshop, ImageJ, Optical Devices, Medical Imaging, Image Processing, Digital Cameras, High Resolution, Photodiodes, Lighting, Design Control, Usability, FDA, Physics, Optics, R&D, Rapid Prototyping, Feasibility Studies, Pre-clinical Studies, Intellectual Property, Biomedical Engineering, Laser, Clinical Trials, ISO 13485, Validation, ISO 14971
Education
University of Southern California 1997 — 2001
Ph.D., Biomedical Engineering
University of Southern California 1995 — 1997
Master of Science (MS), Biomedical Engineering
University of California, San Diego 1990 — 1994
B.S, Electrical Engineering - Photonics
Oraya Therapeutics, Inc. August 2014 - Present
Oraya Therapeutics, Inc. 2012 - Present
Oraya Therapeutics, Inc. 2008 - 2012
Oraya Therapeutics, Inc. April 2007 - 2008
Advanced Medical Optics 2006 - April 2007
VISX 2003 - 2006
VISX October 2001 - 2003
Cedars-Sinai Medical Center 1996 - 2001
Skills
Medical Devices, Commercialization, Clinical Data, Clinical Trial Analysis, Clinical Workflow, Technical Marketing, Clinical Support, Matlab, Clinical Training, Marketing Support, Zemax, C++, Labview, Microsoft Office, Microsoft Excel, Photoshop, ImageJ, Optical Devices, Medical Imaging, Image Processing, Digital Cameras, High Resolution, Photodiodes, Lighting, Design Control, Usability, FDA, Physics, Optics, R&D, Rapid Prototyping, Feasibility Studies, Pre-clinical Studies, Intellectual Property, Biomedical Engineering, Laser, Clinical Trials, ISO 13485, Validation, ISO 14971
Education
University of Southern California 1997 — 2001
Ph.D., Biomedical Engineering
University of Southern California 1995 — 1997
Master of Science (MS), Biomedical Engineering
University of California, San Diego 1990 — 1994
B.S, Electrical Engineering - Photonics
Gerry Iglecia's Oraya Therapeutics, Inc. Experience 2012 - Present
Job Medical Device Engineer
Industry Medical Devices
Experience
Oraya Therapeutics, Inc. 2012 - Present
Amaranth Medical, Inc. 2015 - 2015
Amaranth Medical, Inc. 2015 - 2015
Advanced Cooling Therapy, LLC 2013 - 2013
Sonitus Medical Inc. 2012 - 2013
InSound Medical 2011 - 2012
Satiety, Inc. 2010 - 2010
Calibra Medical 2009 - 2010
Asthmatx 2006 - 2009
Medtronic Diabetes 2001 - 2006
Skills
Medical Devices, Product Development, Catheters, Manufacturing, Process Validation, FMEA, Engineering, Six Sigma, Lean Manufacturing, Commercialization, Tooling, Process Development, Team Building, Product Launch, Rapid Prototyping, ISO 13485, Continuous Improvement, Design Control, FDA, Start-ups, Process Engineering, Validation, Medical Device Product..., Quality Systems, Product Design, Design for Manufacturing, Quality System, ISO 14971, ISO, V&V, Supplier Quality, Design of Experiments, Root Cause Analysis, Quality Control, DMAIC, Minitab, Machine Tools, SPC, Engineering Management, Quality Management, Injection Molding, Pro Engineer, Process Simulation, Manufacturing..., GMP, GD&T, R&D, Cross-functional Team..., Quality Assurance, Solidworks
Education
California State University-Northridge 1994 — 2000
MS, Engineering
Oraya Therapeutics, Inc. 2012 - Present
Amaranth Medical, Inc. 2015 - 2015
Amaranth Medical, Inc. 2015 - 2015
Advanced Cooling Therapy, LLC 2013 - 2013
Sonitus Medical Inc. 2012 - 2013
InSound Medical 2011 - 2012
Satiety, Inc. 2010 - 2010
Calibra Medical 2009 - 2010
Asthmatx 2006 - 2009
Medtronic Diabetes 2001 - 2006
Skills
Medical Devices, Product Development, Catheters, Manufacturing, Process Validation, FMEA, Engineering, Six Sigma, Lean Manufacturing, Commercialization, Tooling, Process Development, Team Building, Product Launch, Rapid Prototyping, ISO 13485, Continuous Improvement, Design Control, FDA, Start-ups, Process Engineering, Validation, Medical Device Product..., Quality Systems, Product Design, Design for Manufacturing, Quality System, ISO 14971, ISO, V&V, Supplier Quality, Design of Experiments, Root Cause Analysis, Quality Control, DMAIC, Minitab, Machine Tools, SPC, Engineering Management, Quality Management, Injection Molding, Pro Engineer, Process Simulation, Manufacturing..., GMP, GD&T, R&D, Cross-functional Team..., Quality Assurance, Solidworks
Education
California State University-Northridge 1994 — 2000
MS, Engineering
Garth Nobis's Oraya Therapeutics, Inc. Experience December 2007 - November 2009
Job Vice President, Regulatory Affairs and Quality Assurance at ViewRay Incorporated
Industry Medical Devices
Experience
ViewRay Incorporated July 2013 - Present
Allergan February 2011 - September 2012
Consulting, Medical Device 2010 - February 2011
Oraya Therapeutics, Inc. December 2007 - November 2009
Accuray Incorporated 2002 - 2007
Guidant Corporation (Vascular Intervention Group) 1997 - 2002
BD Biosciences-BD Immunocytometry 1992 - 1997
Skills
FDA, Design Control, ISO 13485, Medical Devices, Quality System, Regulatory Affairs, GMP, FDA UDI Unique Device...
Education
Kettering University
BIE
University of Dayton
MBA
ViewRay Incorporated July 2013 - Present
Allergan February 2011 - September 2012
Consulting, Medical Device 2010 - February 2011
Oraya Therapeutics, Inc. December 2007 - November 2009
Accuray Incorporated 2002 - 2007
Guidant Corporation (Vascular Intervention Group) 1997 - 2002
BD Biosciences-BD Immunocytometry 1992 - 1997
Skills
FDA, Design Control, ISO 13485, Medical Devices, Quality System, Regulatory Affairs, GMP, FDA UDI Unique Device...
Education
Kettering University
BIE
University of Dayton
MBA
Kenneth Berendes's Oraya Therapeutics, Inc. Experience September 2011 - Present
Job Consultant at Oraya Therapeutics, Inc.
Industry Information Technology and Services
Experience
Oraya Therapeutics, Inc. September 2011 - Present
Roche Palo Alto January 2001 - December 2010
Digital Equipment Corporation January 1999 - December 2000
Digital Equipment Corporation January 1978 - December 1999
Skills
Windows, Active Directory, Storage, VMware, Servers
Education
National University 1996 — 1998
BS, Computer Science
National University 1996 — 1998
Bachelor of Science, Computer Science
Oraya Therapeutics, Inc. September 2011 - Present
Roche Palo Alto January 2001 - December 2010
Digital Equipment Corporation January 1999 - December 2000
Digital Equipment Corporation January 1978 - December 1999
Skills
Windows, Active Directory, Storage, VMware, Servers
Education
National University 1996 — 1998
BS, Computer Science
National University 1996 — 1998
Bachelor of Science, Computer Science
Ronald Carson's Oraya Therapeutics, Inc. Experience September 2012 - February 2013
Job Req/Config/Reliability Mgr at Parsons Corporation
Industry Civil Engineering
Experience
Parsons February 2014 - Present
St Jude Medical September 2013 - February 2014
Parker Aerospace February 2013 - July 2013
Oraya Therapeutics, Inc. September 2012 - February 2013
Honeywell Aerospace June 2012 - August 2012
Astronautics Corporation of America November 2010 - June 2012
BAE Systems Corporation January 2009 - June 2009
BAE Systems Inc./Marconi Astronics Inc January 2009 - June 2009
lockheed Marton 2007 - 2009
Lockheed Martin Corporation July 2008 - October 2008
Skills
MS Project, Testing, Microsoft Office, Integration, Systems Engineering, Quality Assurance, Embedded Software, Software Documentation, Requirements Analysis, Visio, Linux, Embedded Systems, Unix, Program Management, System Testing, Configuration Management, SDLC, System Architecture, Operating Systems, Technical Writing, C++, Six Sigma, DoD, Earned Value Management, Perl, Databases, Security Clearance, Avionics, Simulations, Test Automation, Engineering, TCP/IP, Electronics, Hardware, Aerospace, Engineering Management, Requirements Management, Microsoft Project
Education
The Ohio State University 1973 — 1977
BSAAE, Aerospace Engineering
Cuyahoga Community College 1968 — 1972
AS, Pre-Engineering
Ohio University 1965 — 1967
None, Journalism
Parsons February 2014 - Present
St Jude Medical September 2013 - February 2014
Parker Aerospace February 2013 - July 2013
Oraya Therapeutics, Inc. September 2012 - February 2013
Honeywell Aerospace June 2012 - August 2012
Astronautics Corporation of America November 2010 - June 2012
BAE Systems Corporation January 2009 - June 2009
BAE Systems Inc./Marconi Astronics Inc January 2009 - June 2009
lockheed Marton 2007 - 2009
Lockheed Martin Corporation July 2008 - October 2008
Skills
MS Project, Testing, Microsoft Office, Integration, Systems Engineering, Quality Assurance, Embedded Software, Software Documentation, Requirements Analysis, Visio, Linux, Embedded Systems, Unix, Program Management, System Testing, Configuration Management, SDLC, System Architecture, Operating Systems, Technical Writing, C++, Six Sigma, DoD, Earned Value Management, Perl, Databases, Security Clearance, Avionics, Simulations, Test Automation, Engineering, TCP/IP, Electronics, Hardware, Aerospace, Engineering Management, Requirements Management, Microsoft Project
Education
The Ohio State University 1973 — 1977
BSAAE, Aerospace Engineering
Cuyahoga Community College 1968 — 1972
AS, Pre-Engineering
Ohio University 1965 — 1967
None, Journalism
Mark Vishnevskiy's Oraya Therapeutics, Inc. Experience March 2008 - June 2009
Job Senior Software Test Engineer at eNeura
Industry Computer Software
Experience
eNeura May 2013 - Present
AccuVein April 2012 - September 2013
St. Jude Medical, Neuromodulation Division July 2011 - December 2011
Spinal Modulation March 2010 - March 2011
Oraya Therapeutics, Inc. March 2008 - June 2009
Novo Nordisk Delivery Technologies November 2007 - January 2008
Invivodata May 2007 - October 2007
Gibson Audio December 2003 - December 2006
Skills
Medical Devices, Embedded Systems, FDA, Testing, Software Verification, System Verification, Quality Assurance, Design Control, Test Planning, Software Documentation, ISO 13485, Agile Methodologies, V&V, SDLC, Software Development, Regression Testing, Quality Control, Software Quality...
Education
Saint Petersburg State University 1976 — 1984
eNeura May 2013 - Present
AccuVein April 2012 - September 2013
St. Jude Medical, Neuromodulation Division July 2011 - December 2011
Spinal Modulation March 2010 - March 2011
Oraya Therapeutics, Inc. March 2008 - June 2009
Novo Nordisk Delivery Technologies November 2007 - January 2008
Invivodata May 2007 - October 2007
Gibson Audio December 2003 - December 2006
Skills
Medical Devices, Embedded Systems, FDA, Testing, Software Verification, System Verification, Quality Assurance, Design Control, Test Planning, Software Documentation, ISO 13485, Agile Methodologies, V&V, SDLC, Software Development, Regression Testing, Quality Control, Software Quality...
Education
Saint Petersburg State University 1976 — 1984
Michael Ide's Oraya Therapeutics, Inc. Experience February 2012 - March 2013
Job Quality Inspector / IQA / Inventory Management
Industry Medical Devices
Experience
Private Healthcare Systems Company March 2013 - Present
Oraya Therapeutics, Inc. February 2012 - March 2013
XOMA 2010 - 2012
Allergy Research Group June 2009 - May 2010
Lee Utterbach, Inc. March 1998 - May 2008
Skills
Process Improvement, Biotechnology, FDA, Quality Control, Quality Assurance, GMP, Medical Devices, CMM, Inspection, Inventory Management, Inventory Control, Oracle E-Business Suite, Agile PLM, Intuitive ERP Software, Sage MAS200, QAD, Change Control, ISO 13485, Management, Software Documentation, SOP, Customer Service, Microsoft Office, Microsoft Word, Microsoft Excel, Manufacturing, Quality System
Education
University of California, Berkeley
Bachelor of Arts, Legal Studies
Private Healthcare Systems Company March 2013 - Present
Oraya Therapeutics, Inc. February 2012 - March 2013
XOMA 2010 - 2012
Allergy Research Group June 2009 - May 2010
Lee Utterbach, Inc. March 1998 - May 2008
Skills
Process Improvement, Biotechnology, FDA, Quality Control, Quality Assurance, GMP, Medical Devices, CMM, Inspection, Inventory Management, Inventory Control, Oracle E-Business Suite, Agile PLM, Intuitive ERP Software, Sage MAS200, QAD, Change Control, ISO 13485, Management, Software Documentation, SOP, Customer Service, Microsoft Office, Microsoft Word, Microsoft Excel, Manufacturing, Quality System
Education
University of California, Berkeley
Bachelor of Arts, Legal Studies
Randy Banales's Oraya Therapeutics, Inc. Experience January 2013 - Present
Job Consultant at Oraya Therapeutics, Inc.
Industry Medical Devices
Experience
Oraya Therapeutics, Inc. January 2013 - Present
MiCardia Corporation 2012 - Present
Medtronic September 1975 - Present
Skills
Medical Device..., Controlled Environments, Materials Of Animal..., Sterilization, Microbiology
Education
Cal Poly Pomona 1977 — 1981
Bachelor's degree, Medical Microbiology and Bacteriology
Oraya Therapeutics, Inc. January 2013 - Present
MiCardia Corporation 2012 - Present
Medtronic September 1975 - Present
Skills
Medical Device..., Controlled Environments, Materials Of Animal..., Sterilization, Microbiology
Education
Cal Poly Pomona 1977 — 1981
Bachelor's degree, Medical Microbiology and Bacteriology
Aerotek
Honeywell Aerospace
BE Aerospace
CoStar Group
Mohawk Industries
TruGreen
Transwestern
Sierra Nevada Corporation