OrbusNeich Medical
Industry: Medical device company
DescriptionOrbusNeich is a global company that designs, develops, manufactures and markets medical devices for the treatment of vascular diseases. In 2013, OrbusNeich received CE mark for the world’s first and only dual therapy stent, the COMBO Dual Therapy Stent. Headquarters: Hong Kong Founded: 2005 Number of employees: 500 Subsidiaries: Orbusneich Medical B.V., Orbus International B.V. Type of business: Privately held company Areas served: Florida, Shenzhen, Hoevelaken
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OrbusNeich Medical Employees
Employee
Years
Job
Industry
Jeff O'Hern, PMP Jeff O'Hern, PMP's OrbusNeich Medical Experience 2001 - 2003
Job Senior Program Manager, Connected Homes group at Honeywell
Industry Medical Devices
Experience
Honeywell August 2014 - Present
OptumInsight August 2013 - August 2014
American Medical Systems December 2006 - June 2013
ev3 2003 - 2006
OrbusNeich Medical 2001 - 2003
Johnson & Johnson March 2001 - January 2002
Boston Scientific 1997 - 2001
Skills
Design Control, Medical Devices, FDA, V&V, Cross-functional Team..., Design of Experiments, Validation, GMP, SPC, Product Development, Product Launch, Six Sigma, Quality System, CAPA, Manufacturing, Engineering, Continuous Improvement, FMEA, ISO 13485, Biomedical Engineering, Design for Manufacturing, Manufacturing..., Testing, Engineering Management, Lean Manufacturing, ISO 14971, DMAIC, Minitab, Commercialization, R&D, ISO
Education
PMP Certified 2011 — 2011
Saint Mary's University of Minnesota 2007 — 2010
MA, International Business
Marquette University 1990 — 1994
BS, Biomedical Engineering
Totino Grace High School
Honeywell August 2014 - Present
OptumInsight August 2013 - August 2014
American Medical Systems December 2006 - June 2013
ev3 2003 - 2006
OrbusNeich Medical 2001 - 2003
Johnson & Johnson March 2001 - January 2002
Boston Scientific 1997 - 2001
Skills
Design Control, Medical Devices, FDA, V&V, Cross-functional Team..., Design of Experiments, Validation, GMP, SPC, Product Development, Product Launch, Six Sigma, Quality System, CAPA, Manufacturing, Engineering, Continuous Improvement, FMEA, ISO 13485, Biomedical Engineering, Design for Manufacturing, Manufacturing..., Testing, Engineering Management, Lean Manufacturing, ISO 14971, DMAIC, Minitab, Commercialization, R&D, ISO
Education
PMP Certified 2011 — 2011
Saint Mary's University of Minnesota 2007 — 2010
MA, International Business
Marquette University 1990 — 1994
BS, Biomedical Engineering
Totino Grace High School
Ismael Castellanos Ismael Castellanos's OrbusNeich Medical Experience January 2002 - February 2005
Job Engineer Technician at Xerox
Industry Medical Devices
Experience
Xerox April 2005 - Present
OrbusNeich Medical January 2002 - February 2005
Boston Scientific January 2001 - December 2001
Cordis September 1996 - January 2001
Skills
Manufacturing..., R&D, Medical Devices, Packaging Engineering, Six Sigma, DFLSS, AutoCAD, NX 6, Troubleshooting, Microsoft Office, Corel Draw, UV/Vis, Materials Testing, Validation, Cross-functional Team..., ISO, Engineering, Manufacturing, Design of Experiments
Education
Portland Community College 1992 — 1994
Associate's degree, Mechanical Engineering
Xerox April 2005 - Present
OrbusNeich Medical January 2002 - February 2005
Boston Scientific January 2001 - December 2001
Cordis September 1996 - January 2001
Skills
Manufacturing..., R&D, Medical Devices, Packaging Engineering, Six Sigma, DFLSS, AutoCAD, NX 6, Troubleshooting, Microsoft Office, Corel Draw, UV/Vis, Materials Testing, Validation, Cross-functional Team..., ISO, Engineering, Manufacturing, Design of Experiments
Education
Portland Community College 1992 — 1994
Associate's degree, Mechanical Engineering
Robert Connolly Robert Connolly's OrbusNeich Medical Experience August 2011 - July 2012
Job QC Analyst III at Aveva Drug Delivery Systems
Industry Pharmaceuticals
Experience
Aveva Drug Delivery Systems July 2012 - Present
OrbusNeich Medical August 2011 - July 2012
Noven Pharmaceuticals April 2007 - July 2011
Vyteris Inc. March 2004 - March 2007
ALK ABELLO February 2003 - February 2004
Eon Laboratories Inc. February 1997 - October 2002
NMC Laboratories July 1994 - February 1997
Skills
GMP, HPLC, Sop, Laboratory, FDA, Testing, Biotechnology, Chromatography, Pharmaceutical Industry, LIMS, GLP, Validation, 21 CFR Part 11, Quality System, Six Sigma, Regulatory Affairs, Pharmaceutics, Gas Chromatography, Quality Control, CAPA, UV/Vis, SOP
Education
National University of Ireland, Galway 1990 — 1992
Masters Degree, Biotechnology
National University of Ireland, Galway 1986 — 1990
Bachelors Degree, Biochemistry
Aveva Drug Delivery Systems July 2012 - Present
OrbusNeich Medical August 2011 - July 2012
Noven Pharmaceuticals April 2007 - July 2011
Vyteris Inc. March 2004 - March 2007
ALK ABELLO February 2003 - February 2004
Eon Laboratories Inc. February 1997 - October 2002
NMC Laboratories July 1994 - February 1997
Skills
GMP, HPLC, Sop, Laboratory, FDA, Testing, Biotechnology, Chromatography, Pharmaceutical Industry, LIMS, GLP, Validation, 21 CFR Part 11, Quality System, Six Sigma, Regulatory Affairs, Pharmaceutics, Gas Chromatography, Quality Control, CAPA, UV/Vis, SOP
Education
National University of Ireland, Galway 1990 — 1992
Masters Degree, Biotechnology
National University of Ireland, Galway 1986 — 1990
Bachelors Degree, Biochemistry
Andrew Deschamps Andrew Deschamps's OrbusNeich Medical Experience November 2009 - February 2012
Job Forensic Scientist at New York City Police Department Police Laboratory
Industry Research
Experience
DC37 Local 375 chapter 9 January 2014 - Present
New York City Police Laboratory February 2012 - Present
OrbusNeich Medical November 2009 - February 2012
Genapure March 2008 - November 2009
Skills
HPLC, Laboratory
Education
Florida Atlantic University 2004 — 2008
BS, Biological Sciences; Pre-medical/Pre-professional
DC37 Local 375 chapter 9 January 2014 - Present
New York City Police Laboratory February 2012 - Present
OrbusNeich Medical November 2009 - February 2012
Genapure March 2008 - November 2009
Skills
HPLC, Laboratory
Education
Florida Atlantic University 2004 — 2008
BS, Biological Sciences; Pre-medical/Pre-professional
Alfredo Cardona, CQA Alfredo Cardona, CQA's OrbusNeich Medical Experience June 2012 - February 2015
Job President / Owner at Cardona Quality Consulting
Industry Pharmaceuticals
Experience
Cardona Quality Consulting February 2015 - Present
OrbusNeich Medical June 2012 - February 2015
Sentry Manufactruing December 2009 - February 2012
Arnet Pharmaceuticals March 2009 - January 2010
Nature's Products Inc 2007 - March 2009
Arnet Pharmaceutical 2009 - 2009
Andrx Pharmaceuticals 1999 - 2007
andrx 1999 - 2007
Watson 1999 - 2007
DPT Laboratories 1997 - 1999
Skills
CQA, CAPA, GMP, Validation, V&V, Quality System, Sop, 21 CFR Part 11, Pharmaceutical Industry, Cleaning Validation, Change Control, Medical Devices
Education
Rutgers, The State University of New Jersey-Camden 1988 — 1992
Bachelor of Arts (B.A.), Chemistry
Vineland Senior High School 1984 — 1988
High School
Cardona Quality Consulting February 2015 - Present
OrbusNeich Medical June 2012 - February 2015
Sentry Manufactruing December 2009 - February 2012
Arnet Pharmaceuticals March 2009 - January 2010
Nature's Products Inc 2007 - March 2009
Arnet Pharmaceutical 2009 - 2009
Andrx Pharmaceuticals 1999 - 2007
andrx 1999 - 2007
Watson 1999 - 2007
DPT Laboratories 1997 - 1999
Skills
CQA, CAPA, GMP, Validation, V&V, Quality System, Sop, 21 CFR Part 11, Pharmaceutical Industry, Cleaning Validation, Change Control, Medical Devices
Education
Rutgers, The State University of New Jersey-Camden 1988 — 1992
Bachelor of Arts (B.A.), Chemistry
Vineland Senior High School 1984 — 1988
High School
Jonathan Greenwald Jonathan Greenwald's OrbusNeich Medical Experience May 2010 - November 2011
Job Sr. Project Manager at Stryker
Industry Medical Devices
Experience
Stryker August 2015 - Present
Stryker August 2014 - July 2015
Stryker December 2012 - August 2014
Stryker March 2011 - December 2012
OrbusNeich Medical May 2010 - November 2011
FxDEVICES May 2010 - March 2011
US Spine August 2007 - May 2010
University of Florida August 2006 - August 2007
Skills
Solidworks, Medical Devices, Product Development, Biomedical Engineering, Pro Engineer, V&V, Product Launch, Design Control, FDA, Product Design, Biomechanics, ISO 13485, Cross-functional Team..., Finite Element Analysis, Orthopedic, Design of Experiments, Surgical Instruments, Manufacturing, PTC Creo, Hip Replacement, Spine, Knee Surgery, Project Management, ISO 14971, Quality System, CAPA, Material Selection, Cosmos FEA, ANSYS, Operating Room, Six Sigma, Lean Manufacturing, R&D, Surgeons, Medical Imaging, Robotics, Root Cause Analysis, Market Development, Testing, Management, Trauma, Systems Engineering, Capital Equipment, Design for Manufacturing, FMEA, Validation, Commercialization, Continuous Improvement, Operations Management
Education
University of Florida - Warrington College Of Business 2014 — 2016
Master of Business Administration (MBA), Business Administration and Management, General
University of Southern California 2008 — 2010
Master of Science, Biomedical Engineering - Medical Device and Diagnostic Engineering
University of Florida 2003 — 2007
Materials Science & Engineering, Emphasis on Biomaterials
Stryker August 2015 - Present
Stryker August 2014 - July 2015
Stryker December 2012 - August 2014
Stryker March 2011 - December 2012
OrbusNeich Medical May 2010 - November 2011
FxDEVICES May 2010 - March 2011
US Spine August 2007 - May 2010
University of Florida August 2006 - August 2007
Skills
Solidworks, Medical Devices, Product Development, Biomedical Engineering, Pro Engineer, V&V, Product Launch, Design Control, FDA, Product Design, Biomechanics, ISO 13485, Cross-functional Team..., Finite Element Analysis, Orthopedic, Design of Experiments, Surgical Instruments, Manufacturing, PTC Creo, Hip Replacement, Spine, Knee Surgery, Project Management, ISO 14971, Quality System, CAPA, Material Selection, Cosmos FEA, ANSYS, Operating Room, Six Sigma, Lean Manufacturing, R&D, Surgeons, Medical Imaging, Robotics, Root Cause Analysis, Market Development, Testing, Management, Trauma, Systems Engineering, Capital Equipment, Design for Manufacturing, FMEA, Validation, Commercialization, Continuous Improvement, Operations Management
Education
University of Florida - Warrington College Of Business 2014 — 2016
Master of Business Administration (MBA), Business Administration and Management, General
University of Southern California 2008 — 2010
Master of Science, Biomedical Engineering - Medical Device and Diagnostic Engineering
University of Florida 2003 — 2007
Materials Science & Engineering, Emphasis on Biomaterials
Enora Rogers, PE, CRE Enora Rogers, PE, CRE's OrbusNeich Medical Experience 2001 - 2004
Job Experienced Medical Device Product Development Consultant
Industry Medical Devices
Experience
Enora Rogers, Inc. 2005 - Present
OrbusNeich Medical 2001 - 2004
Cordis 1993 - 2001
Theratek (Division of Dow Corning Wright) 1986 - 1993
Cordis 1984 - 1986
Skills
ISO 13485, Medical Devices, Quality System, Biomedical Engineering, Testing, Biotechnology, FDA, Design Control, V&V, CE marking, Validation, CAPA, Manufacturing, Reliability, Product Development, ISO 14971, Root Cause Analysis, R&D, Design of Experiments, Commercialization, Engineering, GMP, FMEA, Product Launch
Education
Massachusetts Institute of Technology 1982 — 1984
SM
Massachusetts Institute of Technology 1976 — 1980
SB
Enora Rogers, Inc. 2005 - Present
OrbusNeich Medical 2001 - 2004
Cordis 1993 - 2001
Theratek (Division of Dow Corning Wright) 1986 - 1993
Cordis 1984 - 1986
Skills
ISO 13485, Medical Devices, Quality System, Biomedical Engineering, Testing, Biotechnology, FDA, Design Control, V&V, CE marking, Validation, CAPA, Manufacturing, Reliability, Product Development, ISO 14971, Root Cause Analysis, R&D, Design of Experiments, Commercialization, Engineering, GMP, FMEA, Product Launch
Education
Massachusetts Institute of Technology 1982 — 1984
SM
Massachusetts Institute of Technology 1976 — 1980
SB
Shruti Sudam, CQA Shruti Sudam, CQA's OrbusNeich Medical Experience June 2006 - February 2009
Job Quality Engineer
Industry Medical Devices
Experience
Skeletal Dynamics, LLC March 2009 - August 2011
OrbusNeich Medical June 2006 - February 2009
Custom Craft Company May 2004 - June 2006
University of Miami January 2003 - May 2004
Skills
Medical Devices, SPC, ISO 13485, Lean Manufacturing, Surgical Instruments, CAPA, GMP, V&V, Orthopedic, FDA, Spine, Biomedical Engineering, Six Sigma, Quality System, Product Launch, Capital Equipment, Validation
Education
University of Miami 2003 — 2004
Syracuse University 2002 — 2003
Biomedical Engg
Osmania University 1998 — 2002
BS, Biomedical Engineering
Skeletal Dynamics, LLC March 2009 - August 2011
OrbusNeich Medical June 2006 - February 2009
Custom Craft Company May 2004 - June 2006
University of Miami January 2003 - May 2004
Skills
Medical Devices, SPC, ISO 13485, Lean Manufacturing, Surgical Instruments, CAPA, GMP, V&V, Orthopedic, FDA, Spine, Biomedical Engineering, Six Sigma, Quality System, Product Launch, Capital Equipment, Validation
Education
University of Miami 2003 — 2004
Syracuse University 2002 — 2003
Biomedical Engg
Osmania University 1998 — 2002
BS, Biomedical Engineering
Arvind Parsan's OrbusNeich Medical Experience May 2008 - August 2008
Job Mechanical Design Engineer at Nipro Diagnostics (formerly Home Diagnostics)
Industry Medical Devices
Experience
Nipro Diagnostics (formerly Home Diagnostics) January 2013 - June 2015
Miami Children's Hospital September 2009 - May 2010
Boston Scientific May 2009 - May 2010
OrbusNeich Medical May 2008 - August 2008
Florida International University, Organic Chemistry Lab June 2005 - August 2005
Skills
Solidworks, Medical Devices, Quality System, Matlab, COMSOL, Machining, Iso 9000, MS Project, Mechanical Analysis, Cell Culture, Software, Biomedical Engineering, Component Engineering, V&V, CAPA, ISO 13485, Design Control, Minitab, Cardiovascular Disease, FDA, Quality Assurance, Engineering, FMEA, Six Sigma, Manufacturing, Design of Experiments, ISO, Testing, Validation, Root Cause Analysis, Quality Control, GMP, R&D, Microsoft Office, Product Development, Mechanical Engineering, LabVIEW, Design for Manufacturing
Education
Florida International University 2010 — 2012
Master of Science, Mechanical Engineering (Design and Manufacturing)
Florida International University 2005 — 2010
Bachelor of Science, Biomedical Engineering and Business
Northeast High School 2001 — 2005
Diploma, General
Nipro Diagnostics (formerly Home Diagnostics) January 2013 - June 2015
Miami Children's Hospital September 2009 - May 2010
Boston Scientific May 2009 - May 2010
OrbusNeich Medical May 2008 - August 2008
Florida International University, Organic Chemistry Lab June 2005 - August 2005
Skills
Solidworks, Medical Devices, Quality System, Matlab, COMSOL, Machining, Iso 9000, MS Project, Mechanical Analysis, Cell Culture, Software, Biomedical Engineering, Component Engineering, V&V, CAPA, ISO 13485, Design Control, Minitab, Cardiovascular Disease, FDA, Quality Assurance, Engineering, FMEA, Six Sigma, Manufacturing, Design of Experiments, ISO, Testing, Validation, Root Cause Analysis, Quality Control, GMP, R&D, Microsoft Office, Product Development, Mechanical Engineering, LabVIEW, Design for Manufacturing
Education
Florida International University 2010 — 2012
Master of Science, Mechanical Engineering (Design and Manufacturing)
Florida International University 2005 — 2010
Bachelor of Science, Biomedical Engineering and Business
Northeast High School 2001 — 2005
Diploma, General
Hameed Hirani's OrbusNeich Medical Experience March 2012 - April 2015
Job MBA Candidate at Kellogg School of Management
Industry Medical Devices
Experience
OrbusNeich Medical March 2012 - April 2015
OrbusNeich Medical April 2011 - March 2012
OrbusNeich Medical November 2007 - April 2011
Goode Compliance International September 2006 - November 2007
Tulane University Housing and Residence Life January 2006 - July 2006
Skills
Biomedical Engineering, Medical Devices, Solidworks, FDA, ISO 13485, Biotechnology, Product Development, Statistics, Engineering, Six Sigma, Microsoft Office, Microsoft Excel, GMP, CAPA, Biomaterials, Quality Assurance, Design Control, R&D, Minitab, ISO 14971, Biomechanics, V&V, Quality System, FMEA, Validation, Manufacturing, Design of Experiments, Root Cause Analysis, Management, PowerPoint, Research, Cross-functional Team..., Program Management, Public Speaking
Education
Northwestern University - Kellogg School of Management 2015 — 2016
Master of Business Administration (M.B.A.)
Tulane University 2005 — 2006
Master of Engineering (MEng), Biomedical/Medical Engineering
Tulane University 2001 — 2006
Bachelor of Science (BSc), Biomedical/Medical Engineering
Palm Harbor University High School 1998 — 2001
OrbusNeich Medical March 2012 - April 2015
OrbusNeich Medical April 2011 - March 2012
OrbusNeich Medical November 2007 - April 2011
Goode Compliance International September 2006 - November 2007
Tulane University Housing and Residence Life January 2006 - July 2006
Skills
Biomedical Engineering, Medical Devices, Solidworks, FDA, ISO 13485, Biotechnology, Product Development, Statistics, Engineering, Six Sigma, Microsoft Office, Microsoft Excel, GMP, CAPA, Biomaterials, Quality Assurance, Design Control, R&D, Minitab, ISO 14971, Biomechanics, V&V, Quality System, FMEA, Validation, Manufacturing, Design of Experiments, Root Cause Analysis, Management, PowerPoint, Research, Cross-functional Team..., Program Management, Public Speaking
Education
Northwestern University - Kellogg School of Management 2015 — 2016
Master of Business Administration (M.B.A.)
Tulane University 2005 — 2006
Master of Engineering (MEng), Biomedical/Medical Engineering
Tulane University 2001 — 2006
Bachelor of Science (BSc), Biomedical/Medical Engineering
Palm Harbor University High School 1998 — 2001
Karla Torruellas Karla Torruellas's OrbusNeich Medical Experience June 2007 - February 2009
Job Technical Manager at EZ Weld, Inc.
Industry Chemicals
Experience
E-Z Weld, Inc. October 2011 - Present
Christ Fellowship Church August 2012 - July 2015
Max Planck Florida Institute April 2010 - March 2011
Biotest Pharmaceuticals April 2009 - April 2010
OrbusNeich Medical June 2007 - February 2009
CyGene Laboratories Inc. January 2006 - April 2007
US Biosystems November 2005 - January 2006
Nabi Biopharmaceuticals June 2005 - November 2005
Florida Atlantic University October 2003 - June 2005
University of Puerto January 2000 - January 2002
Skills
Word, Excel, PowerPoint, Outlook, Spanish, English, Microsoft Office, Windows, Photoshop, Visio, Writing, Adobe Acrobat, Research, MS Project, Internet Explorer, SAP, Data Entry, Spreadsheets, Inventory Management, Typing, SOP, Molecular Biology, GMP, Documentation, Technical Writing, Customer Service, Medical Devices, Troubleshooting, Quality Assurance, Life Sciences, Product Development, Biotechnology, Social Media, Manufacturing, MS Office Suite, Sop, Microsoft Word, Lifesciences, Microsoft Excel, Software Documentation, ELISA, Pharmaceutical Industry, Chromatography
Education
University of Puerto Rico School of Medicine 2002 — 2003
MD, First Year Medicine School
Universidad de Puerto Rico 1998 — 2002
BS, Biology
E-Z Weld, Inc. October 2011 - Present
Christ Fellowship Church August 2012 - July 2015
Max Planck Florida Institute April 2010 - March 2011
Biotest Pharmaceuticals April 2009 - April 2010
OrbusNeich Medical June 2007 - February 2009
CyGene Laboratories Inc. January 2006 - April 2007
US Biosystems November 2005 - January 2006
Nabi Biopharmaceuticals June 2005 - November 2005
Florida Atlantic University October 2003 - June 2005
University of Puerto January 2000 - January 2002
Skills
Word, Excel, PowerPoint, Outlook, Spanish, English, Microsoft Office, Windows, Photoshop, Visio, Writing, Adobe Acrobat, Research, MS Project, Internet Explorer, SAP, Data Entry, Spreadsheets, Inventory Management, Typing, SOP, Molecular Biology, GMP, Documentation, Technical Writing, Customer Service, Medical Devices, Troubleshooting, Quality Assurance, Life Sciences, Product Development, Biotechnology, Social Media, Manufacturing, MS Office Suite, Sop, Microsoft Word, Lifesciences, Microsoft Excel, Software Documentation, ELISA, Pharmaceutical Industry, Chromatography
Education
University of Puerto Rico School of Medicine 2002 — 2003
MD, First Year Medicine School
Universidad de Puerto Rico 1998 — 2002
BS, Biology
Crystal Placona's OrbusNeich Medical Experience July 2013 - Present
Job Regulatory Affairs Associate III at OrbusNeich Medical
Industry Pharmaceuticals
Experience
OrbusNeich Medical July 2013 - Present
OrbusNeich Medical June 2012 - June 2013
Baxter Corporation May 2008 - November 2011
Baxter International Inc. May 2008 - November 2011
Skills
RAC (US) Distinction -..., Regulatory Affairs, Sop, Change Control, Electronic Submissions, Regulatory Submissions, Regulatory Requirements, FDA, GMP, Pharmaceutical Industry, Regulatory Intelligence, Medical Devices
Education
Humber College 2007 — 2008
Post-Graduate Certificate, Regulatory Affairs
Western University 2003 — 2007
Bachelor of Medical Sciences, Pharmacology and Toxicology
OrbusNeich Medical July 2013 - Present
OrbusNeich Medical June 2012 - June 2013
Baxter Corporation May 2008 - November 2011
Baxter International Inc. May 2008 - November 2011
Skills
RAC (US) Distinction -..., Regulatory Affairs, Sop, Change Control, Electronic Submissions, Regulatory Submissions, Regulatory Requirements, FDA, GMP, Pharmaceutical Industry, Regulatory Intelligence, Medical Devices
Education
Humber College 2007 — 2008
Post-Graduate Certificate, Regulatory Affairs
Western University 2003 — 2007
Bachelor of Medical Sciences, Pharmacology and Toxicology
Sherry Parker's OrbusNeich Medical Experience December 2010 - April 2011
Job Director, Technical and Regulatory, Medical Devices at WuXi AppTec
Industry Medical Devices
Experience
WuXi AppTec April 2011 - Present
OrbusNeich Medical December 2010 - April 2011
OrbusNeich Medical, Inc. 2004 - December 2009
RTI November 2001 - September 2004
US EPA October 1999 - November 2001
Skills
Design Control, Medical Devices, GMP, Manufacturing, Validation, Pharmaceutical Industry, Regulatory Affairs, CAPA, Biomedical Engineering, Biotechnology, R&D, GLP, Lifesciences, ISO 13485, Product Development, Quality System, FDA, Sop, ISO 14971, Life Sciences, Regulatory Submissions, V
Education
University of Miami Leonard M. Miller School of Medicine 1989 — 1995
PhD, Molecular and Cellular Pharmacology
University of Miami
Doctor of Philosophy (PhD), Molecular and Cellular Pharmacology
WuXi AppTec April 2011 - Present
OrbusNeich Medical December 2010 - April 2011
OrbusNeich Medical, Inc. 2004 - December 2009
RTI November 2001 - September 2004
US EPA October 1999 - November 2001
Skills
Design Control, Medical Devices, GMP, Manufacturing, Validation, Pharmaceutical Industry, Regulatory Affairs, CAPA, Biomedical Engineering, Biotechnology, R&D, GLP, Lifesciences, ISO 13485, Product Development, Quality System, FDA, Sop, ISO 14971, Life Sciences, Regulatory Submissions, V
Education
University of Miami Leonard M. Miller School of Medicine 1989 — 1995
PhD, Molecular and Cellular Pharmacology
University of Miami
Doctor of Philosophy (PhD), Molecular and Cellular Pharmacology
Miriam Paret's OrbusNeich Medical Experience February 2008 - July 2015
Job Quality Assurance, Biocompatibility and Preclinical, Regulatory
Industry Medical Devices
Experience
Paret Consulting LLC August 2015 - Present
OrbusNeich Medical February 2008 - July 2015
Cordis, Johnson & Johnson June 1993 - December 2007
Skills
FDA, Validation, ISO 13485, Medical Devices, V&V, Monoclonal Antibodies, Design Control, CAPA, Microbiology, Biotechnology, Sop, Change Control, GMP, Quality System, Minitab, R&D, Biomedical Engineering, ISO 14971, FMEA, Regulatory Affairs, Commercialization, Regulatory Submissions, Design of Experiments, 21 CFR Part 11, GLP, Quality Assurance
Education
Barry University 1994 — 1996
MS, Biomedical Science
University of Miami
Bachelor of Science (BS), Biology/Biological Sciences, General
Paret Consulting LLC August 2015 - Present
OrbusNeich Medical February 2008 - July 2015
Cordis, Johnson & Johnson June 1993 - December 2007
Skills
FDA, Validation, ISO 13485, Medical Devices, V&V, Monoclonal Antibodies, Design Control, CAPA, Microbiology, Biotechnology, Sop, Change Control, GMP, Quality System, Minitab, R&D, Biomedical Engineering, ISO 14971, FMEA, Regulatory Affairs, Commercialization, Regulatory Submissions, Design of Experiments, 21 CFR Part 11, GLP, Quality Assurance
Education
Barry University 1994 — 1996
MS, Biomedical Science
University of Miami
Bachelor of Science (BS), Biology/Biological Sciences, General
Scott Addonizio's OrbusNeich Medical Experience 2014 - 2015
Job Senior Vice President Global Operations, General Manager OrbusNeich Shenzhen
Industry Medical Devices
Experience
OrbusNeich Medical SZ January 2005 - Present
OrbusNeich Medical 2014 - 2015
Johnson & Johnson May 1995 - January 1998
Skills
Medical Devices, Product Development, FDA, Product Launch, ISO 13485, R&D, Market Development, CAPA, Design Control, Quality System
Education
University of Miami - School of Business 1997 — 1998
Masters, International Business
Michigan State University 1990 — 1995
Bachelor’s Degree, Packaging Engineering
OrbusNeich Medical SZ January 2005 - Present
OrbusNeich Medical 2014 - 2015
Johnson & Johnson May 1995 - January 1998
Skills
Medical Devices, Product Development, FDA, Product Launch, ISO 13485, R&D, Market Development, CAPA, Design Control, Quality System
Education
University of Miami - School of Business 1997 — 1998
Masters, International Business
Michigan State University 1990 — 1995
Bachelor’s Degree, Packaging Engineering
Deborah Deutsch's OrbusNeich Medical Experience November 2007 - March 2010
Job Director of Quality Compliance at Edwards Lifesciences
Industry Medical Devices
Experience
Edwards Lifesciences July 2011 - Present
Edwards Lifesciences April 2010 - July 2011
OrbusNeich Medical November 2007 - March 2010
Cordis Corp., A Johnson & Johnson Co. April 2003 - November 2007
Skills
ISO 13485, Medical Devices, FDA, Stents, Heart Valves
Education
University of Pennsylvania 1988 — 1992
Bachelor of Science in Nursing, Registered Nursing/Registered Nurse
Edwards Lifesciences July 2011 - Present
Edwards Lifesciences April 2010 - July 2011
OrbusNeich Medical November 2007 - March 2010
Cordis Corp., A Johnson & Johnson Co. April 2003 - November 2007
Skills
ISO 13485, Medical Devices, FDA, Stents, Heart Valves
Education
University of Pennsylvania 1988 — 1992
Bachelor of Science in Nursing, Registered Nursing/Registered Nurse
Laurence Hanks's OrbusNeich Medical Experience 2014 - Present
Job Staff Chemist, Product Development at OrbusNeich Medical
Industry Medical Devices
Experience
OrbusNeich Medical 2014 - Present
OrbusNeich Medical 2012 - 2014
OrbusNeich Medical 2007 - 2012
Education
University of Warwick 2001 — 2006
PhD, Chemistry
Université de Montpellier 1993 — 1999
Maitrise, Chemistry
OrbusNeich Medical 2014 - Present
OrbusNeich Medical 2012 - 2014
OrbusNeich Medical 2007 - 2012
Education
University of Warwick 2001 — 2006
PhD, Chemistry
Université de Montpellier 1993 — 1999
Maitrise, Chemistry
Al Novak's OrbusNeich Medical Experience 2008 - January 2014
Job President and CEO at Syntheon Cardiology, LLC
Industry Medical Devices
Experience
Cyberonics 2007 - Present
Syntheon Cardiology, LLC April 2014 - April 2015
OrbusNeich Medical 2008 - January 2014
OrbusNeich Medical 1998 - January 2014
Novoste Corporation 2001 - 2005
Syntheon, Inc. 1998 - 2003
Biosense, Inc. 1996 - 1998
Cordis Corporation 1984 - 1996
Skills
Medical Devices, FDA, Product Development, Start-ups, Regulatory Affairs, Manufacturing, R&D, Cardiology, Business Strategy, Strategic Planning, Market Development, New Business Development, Biotechnology, Capital Equipment, Commercialization, Healthcare, CAPA, Validation, Cross-functional Team..., Lifesciences, Product Launch, Hardware Diagnostics, GMP, Product Management, Medical Imaging, Strategy, Risk Management, V&V, Interventional..., Biomedical Engineering, Clinical Development, PowerPoint, Pharmaceutical Industry, Life Sciences, Corporate Finance, Executive Management, Mergers, Venture Capital
Education
University of Pennsylvania - The Wharton School 1972 — 1975
Master of Business Administration (M.B.A.), Health Economics
United States Merchant Marine Academy 1965 — 1969
BS, Business
Cyberonics 2007 - Present
Syntheon Cardiology, LLC April 2014 - April 2015
OrbusNeich Medical 2008 - January 2014
OrbusNeich Medical 1998 - January 2014
Novoste Corporation 2001 - 2005
Syntheon, Inc. 1998 - 2003
Biosense, Inc. 1996 - 1998
Cordis Corporation 1984 - 1996
Skills
Medical Devices, FDA, Product Development, Start-ups, Regulatory Affairs, Manufacturing, R&D, Cardiology, Business Strategy, Strategic Planning, Market Development, New Business Development, Biotechnology, Capital Equipment, Commercialization, Healthcare, CAPA, Validation, Cross-functional Team..., Lifesciences, Product Launch, Hardware Diagnostics, GMP, Product Management, Medical Imaging, Strategy, Risk Management, V&V, Interventional..., Biomedical Engineering, Clinical Development, PowerPoint, Pharmaceutical Industry, Life Sciences, Corporate Finance, Executive Management, Mergers, Venture Capital
Education
University of Pennsylvania - The Wharton School 1972 — 1975
Master of Business Administration (M.B.A.), Health Economics
United States Merchant Marine Academy 1965 — 1969
BS, Business
H. Richard Davis's OrbusNeich Medical Experience 2002 - 2005
Job Chief Operating Officer at Tryton Medical, Inc
Industry Medical Devices
Experience
Tryton Medical, Inc March 2005 - Present
Tryton Medical Inc. March 2005 - January 2013
OrbusNeich Medical 2002 - 2005
Orbus International BV 1998 - 2002
Cordis 1994 - 1998
Skills
Minitab, System Design, Medical Devices, Image Analysis, Design Control, ISO 13485, MEMS, Polymers, Design of Experiments, Product Development, Biomedical Engineering, Cross-functional Team..., Market Development, Commercialization, R&D, Global Marketing, V&V, FDA, Quality System, Orthopedic, Capital Equipment, CAPA, Validation, Lifesciences, GMP, Product Launch, Cardiology, Hardware Diagnostics, Medical Imaging, Process Simulation, DMAIC, Design for Manufacturing, Technology Transfer, Biotechnology, Quality Control, Life Sciences, Orthopedics
Education
Florida International University 1993 — 1997
MS, Mechanical / Materials Engineering
Florida International University 1987 — 1992
BS, Mechanical Engineering
Tryton Medical, Inc March 2005 - Present
Tryton Medical Inc. March 2005 - January 2013
OrbusNeich Medical 2002 - 2005
Orbus International BV 1998 - 2002
Cordis 1994 - 1998
Skills
Minitab, System Design, Medical Devices, Image Analysis, Design Control, ISO 13485, MEMS, Polymers, Design of Experiments, Product Development, Biomedical Engineering, Cross-functional Team..., Market Development, Commercialization, R&D, Global Marketing, V&V, FDA, Quality System, Orthopedic, Capital Equipment, CAPA, Validation, Lifesciences, GMP, Product Launch, Cardiology, Hardware Diagnostics, Medical Imaging, Process Simulation, DMAIC, Design for Manufacturing, Technology Transfer, Biotechnology, Quality Control, Life Sciences, Orthopedics
Education
Florida International University 1993 — 1997
MS, Mechanical / Materials Engineering
Florida International University 1987 — 1992
BS, Mechanical Engineering
David Kornhauser's OrbusNeich Medical Experience January 2005 - September 2007
Job V.P. of Regulatory Affairs at Vascular Therapies, inc.
Industry Medical Devices
Experience
Vascular Therapies, inc. May 2012 - Present
Regulatory Consulting April 2012 - May 2012
Micell Technologies August 2010 - April 2012
Vascular Therapies October 2007 - July 2010
OrbusNeich Medical January 2005 - September 2007
Cordis, a Johnson & Johnson company 1996 - 2004
Cordis 1982 - 1996
Skills
Regulatory Affairs, FDA, Medical Devices
Education
Teachers College of Columbia University 1974 — 1980
EdD, Movement Science and Education
Queens College 1970 — 1974
BA, Education
Vascular Therapies, inc. May 2012 - Present
Regulatory Consulting April 2012 - May 2012
Micell Technologies August 2010 - April 2012
Vascular Therapies October 2007 - July 2010
OrbusNeich Medical January 2005 - September 2007
Cordis, a Johnson & Johnson company 1996 - 2004
Cordis 1982 - 1996
Skills
Regulatory Affairs, FDA, Medical Devices
Education
Teachers College of Columbia University 1974 — 1980
EdD, Movement Science and Education
Queens College 1970 — 1974
BA, Education
Daniele Gilkes's OrbusNeich Medical Experience 2001 - 2003
Job Assistant Professor of Oncology at Johns Hopkins University
Industry Research
Experience
Johns Hopkins University August 2015 - Present
Johns Hopkins School of Medicine April 2014 - Present
Johns Hopkins School of Medicine June 2009 - February 2014
OrbusNeich Medical 2001 - 2003
Bell Laboratories 2000 - 2002
Skills
Cell Biology, Molecular Biology
Education
University of South Florida 2003 — 2009
Doctor of Philosophy (Ph.D.), Oncology and Cancer Biology
Johns Hopkins University August 2015 - Present
Johns Hopkins School of Medicine April 2014 - Present
Johns Hopkins School of Medicine June 2009 - February 2014
OrbusNeich Medical 2001 - 2003
Bell Laboratories 2000 - 2002
Skills
Cell Biology, Molecular Biology
Education
University of South Florida 2003 — 2009
Doctor of Philosophy (Ph.D.), Oncology and Cancer Biology
Majid Hemmati's OrbusNeich Medical Experience January 2000 - August 2006
Job Medical Technical Consultant
Industry Medical Devices
Experience
Self-employed September 2006 - Present
OrbusNeich Medical January 2000 - August 2006
Johnson & Johnson October 1996 - January 2000
Skills
Medical Devices, FDA, Cross-functional Team..., R&D, Product Development, ISO 13485, Manufacturing, Design Control, Quality System, Validation
Education
University of Massachusetts Lowell
University of Miami
Self-employed September 2006 - Present
OrbusNeich Medical January 2000 - August 2006
Johnson & Johnson October 1996 - January 2000
Skills
Medical Devices, FDA, Cross-functional Team..., R&D, Product Development, ISO 13485, Manufacturing, Design Control, Quality System, Validation
Education
University of Massachusetts Lowell
University of Miami
Edwards Lifesciences
Welch Allyn
ConvaTec
Masimo Corporation
QuEST Global
Thoratec
Christie Digital Systems
NxStage Medical