Sadra Medical
Industry: Company
DescriptionFounded: 2003 Parent organization: Boston Scientific
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Sadra Medical Employees
Employee
Years
Job
Industry
Craig Buell Craig Buell's Sadra Medical Experience October 2005 - June 2008
Job Product Manager at CR Bard
Industry Biotechnology
Experience
CR Bard June 2014 - Present
ValveXchange May 2011 - May 2014
Baxa Corporation August 2010 - May 2011
CareFusion June 2009 - March 2010
Sadra Medical October 2005 - June 2008
Skills
Medical Devices, Product Development, Marketing Strategy, Program Management, Start-ups, FDA, R&D, Leadership, Design Control, Entrepreneurship, Project Management, Engineering, Product Management, Product Launch, Validation, Cross-functional Team..., ISO 13485, ISO 14971, Commercialization, Quality System, Biotechnology
Education
University of California, San Diego - The Rady School of Management 2008 — 2010
MBA
Stanford University 2001 — 2005
B.S., Management Science and Engineering
CR Bard June 2014 - Present
ValveXchange May 2011 - May 2014
Baxa Corporation August 2010 - May 2011
CareFusion June 2009 - March 2010
Sadra Medical October 2005 - June 2008
Skills
Medical Devices, Product Development, Marketing Strategy, Program Management, Start-ups, FDA, R&D, Leadership, Design Control, Entrepreneurship, Project Management, Engineering, Product Management, Product Launch, Validation, Cross-functional Team..., ISO 13485, ISO 14971, Commercialization, Quality System, Biotechnology
Education
University of California, San Diego - The Rady School of Management 2008 — 2010
MBA
Stanford University 2001 — 2005
B.S., Management Science and Engineering
Gwen Emptage Gwen Emptage's Sadra Medical Experience 2006 - 2007
Job Sr. Regulatory Affairs Specialist at RMS
Industry Medical Devices
Experience
Roche Molecular Systems, Inc. February 2014 - Present
CooperVision July 2011 - January 2014
Access Closure Inc. 2007 - 2010
Sadra Medical 2006 - 2007
Skills
FDA, Medical Devices, Quality Auditing, Quality System, PMA, ISO 13485, Market Development, Regulatory Affairs, Commercialization, Validation, Management, CAPA, Clinical Research, Biotechnology, Sop, Process Improvement, Pharmaceutical Industry, Six Sigma, Quality Assurance, Healthcare, Design Control, Clinical Trials, Product Launch, GMP, V&V, ISO 14971, Regulatory Submissions, Cardiology, 21 CFR Part 11, Regulatory Requirements, Biomedical Engineering, Change Control, Capital Equipment, Hardware Diagnostics, GCP, Clinical Development, SOP
Education
University of California, Santa Cruz 2008 — 2011
Clinical Trials Design and Management, Clinical Trials Design and Management
University of California, Santa Cruz 2007 — 2010
Regulatory Affairs - core credits completed, Regulatory Affairs
San Jose State University 2004 — 2005
Bachelor of Science (BS), Health/Health Care Administration/Management
Roche Molecular Systems, Inc. February 2014 - Present
CooperVision July 2011 - January 2014
Access Closure Inc. 2007 - 2010
Sadra Medical 2006 - 2007
Skills
FDA, Medical Devices, Quality Auditing, Quality System, PMA, ISO 13485, Market Development, Regulatory Affairs, Commercialization, Validation, Management, CAPA, Clinical Research, Biotechnology, Sop, Process Improvement, Pharmaceutical Industry, Six Sigma, Quality Assurance, Healthcare, Design Control, Clinical Trials, Product Launch, GMP, V&V, ISO 14971, Regulatory Submissions, Cardiology, 21 CFR Part 11, Regulatory Requirements, Biomedical Engineering, Change Control, Capital Equipment, Hardware Diagnostics, GCP, Clinical Development, SOP
Education
University of California, Santa Cruz 2008 — 2011
Clinical Trials Design and Management, Clinical Trials Design and Management
University of California, Santa Cruz 2007 — 2010
Regulatory Affairs - core credits completed, Regulatory Affairs
San Jose State University 2004 — 2005
Bachelor of Science (BS), Health/Health Care Administration/Management
Devin Bridgen's Sadra Medical Experience January 2008 - July 2008
Job PhD Candidate at Duke University
Industry Research
Experience
Duke University August 2009 - Present
University Hospital Basel August 2008 - July 2009
Sadra Medical January 2008 - July 2008
Abiomed May 2006 - August 2006
Education
Duke University 2009 — 2015
PhD, Biomedical Engineering
Cornell University 2003 — 2008
BS, M.Eng, Biomedical Engineering
Duke University August 2009 - Present
University Hospital Basel August 2008 - July 2009
Sadra Medical January 2008 - July 2008
Abiomed May 2006 - August 2006
Education
Duke University 2009 — 2015
PhD, Biomedical Engineering
Cornell University 2003 — 2008
BS, M.Eng, Biomedical Engineering
Cece Cao Cece Cao's Sadra Medical Experience July 2006 - September 2006
Job Quality Engineer at OptiMedica
Industry Medical Devices
Experience
OptiMedica March 2011 - Present
Hantel Technologies August 2007 - March 2011
Sadra Medical July 2006 - September 2006
Skills
Manufacturing, Quality System, Validation, Matlab, Medical Devices, Optics, CAPA, Testing, Design of Experiments, Inspection, FDA, Materials, ISO 13485, Visio, Calibration, R&D, Biomedical Engineering, Electronics, Design Control, Labview, Solidworks, V&V, Design for Manufacturing, SPC, Root Cause Analysis
Education
University of California, Davis 2003 — 2007
Bachelor of Science, Materials Science & Engineering
OptiMedica March 2011 - Present
Hantel Technologies August 2007 - March 2011
Sadra Medical July 2006 - September 2006
Skills
Manufacturing, Quality System, Validation, Matlab, Medical Devices, Optics, CAPA, Testing, Design of Experiments, Inspection, FDA, Materials, ISO 13485, Visio, Calibration, R&D, Biomedical Engineering, Electronics, Design Control, Labview, Solidworks, V&V, Design for Manufacturing, SPC, Root Cause Analysis
Education
University of California, Davis 2003 — 2007
Bachelor of Science, Materials Science & Engineering
Katherine Fazackerley Katherine Fazackerley's Sadra Medical Experience June 2010 - June 2011
Job R&D Engineer at Boston Scientific
Industry Medical Devices
Experience
Boston Scientific September 2011 - Present
Boston Scientific June 2011 - September 2011
Sadra Medical June 2010 - June 2011
Education
Santa Clara University 2007 — 2011
Bachelor of Science, Bioengineering, English
Boston Scientific September 2011 - Present
Boston Scientific June 2011 - September 2011
Sadra Medical June 2010 - June 2011
Education
Santa Clara University 2007 — 2011
Bachelor of Science, Bioengineering, English
Daniel Hildebrand's Sadra Medical Experience June 2006 - July 2007
Job Principal Engineer at PowerVision
Industry Medical Devices
Experience
Powervision March 2013 - Present
Powervision December 2008 - March 2013
Nfocus Neuromedical July 2007 - November 2008
Sadra Medical June 2006 - July 2007
Sadra Medical January 2005 - June 2006
Sadra Medical March 2004 - January 2005
University of Pittsburgh 1999 - 2003
Skills
Medical Devices, Design Control, R&D, Solidworks, Finite Element Analysis, Labview, Design of Experiments, Python, Software, Image Processing, Rapid Prototyping, Instrumentation, Protocol Design, Test Automation, Hardware Development, Nitinol, Implants, Stents, ISO 13485, Medical Imaging, Abaqus, LabVIEW, Biomedical Engineering
Education
University of Pittsburgh 1997 — 2003
MSE, BSE, Bioengineering
Powervision March 2013 - Present
Powervision December 2008 - March 2013
Nfocus Neuromedical July 2007 - November 2008
Sadra Medical June 2006 - July 2007
Sadra Medical January 2005 - June 2006
Sadra Medical March 2004 - January 2005
University of Pittsburgh 1999 - 2003
Skills
Medical Devices, Design Control, R&D, Solidworks, Finite Element Analysis, Labview, Design of Experiments, Python, Software, Image Processing, Rapid Prototyping, Instrumentation, Protocol Design, Test Automation, Hardware Development, Nitinol, Implants, Stents, ISO 13485, Medical Imaging, Abaqus, LabVIEW, Biomedical Engineering
Education
University of Pittsburgh 1997 — 2003
MSE, BSE, Bioengineering
Olin Palmer Olin Palmer's Sadra Medical Experience July 2005 - April 2006
Job Medical Device Entrepreneur
Industry Medical Devices
Experience
BioCardia August 2009 - August 2015
Neurofluidics April 2008 - July 2013
BioCardia September 2006 - April 2008
Self-employed August 2003 - October 2006
Sadra Medical July 2005 - April 2006
NeuroPace 2006 - 2006
Guidant - Compass, Business Development Group May 1998 - August 2003
Medtronic MIS (Micro Interventional Systems) 1996 - 1998
Advanced Cardiovascular Systems 1989 - 1996
Skills
Medical Devices, R&D, Product Development, V&V, Design Control, ISO 13485, FDA, Manufacturing, Product Design, Lean Manufacturing, Biomedical Engineering, Engineering, Cross-functional Team..., Solidworks, Start-ups, Design for Manufacturing, Design of Experiments, Drug Delivery, Quality System, Biotechnology, Validation, ISO 14971, Commercialization, CAPA, Product Launch, Testing, FMEA, Continuous Improvement, Process Simulation, ISO, GMP, Lifesciences, Process Engineering, Injection Molding, Manufacturing..., Root Cause Analysis, Market Development, Manufacturing Operations, Quality Assurance, SPC, Regulatory Affairs, Quality Control, Quality Management, Supplier Quality, Engineering Management, Six Sigma, Technology Transfer, Life Sciences, SolidWorks
Education
Columbia University - Columbia Business School
MBA, Entrepreneurship/Entrepreneurial Studies
San Diego State University-California State University
BSME, Mechanical Engieering
University of California, Berkeley - Walter A. Haas School of Business
Master of Business Administration (MBA), Entrepreneurship
BioCardia August 2009 - August 2015
Neurofluidics April 2008 - July 2013
BioCardia September 2006 - April 2008
Self-employed August 2003 - October 2006
Sadra Medical July 2005 - April 2006
NeuroPace 2006 - 2006
Guidant - Compass, Business Development Group May 1998 - August 2003
Medtronic MIS (Micro Interventional Systems) 1996 - 1998
Advanced Cardiovascular Systems 1989 - 1996
Skills
Medical Devices, R&D, Product Development, V&V, Design Control, ISO 13485, FDA, Manufacturing, Product Design, Lean Manufacturing, Biomedical Engineering, Engineering, Cross-functional Team..., Solidworks, Start-ups, Design for Manufacturing, Design of Experiments, Drug Delivery, Quality System, Biotechnology, Validation, ISO 14971, Commercialization, CAPA, Product Launch, Testing, FMEA, Continuous Improvement, Process Simulation, ISO, GMP, Lifesciences, Process Engineering, Injection Molding, Manufacturing..., Root Cause Analysis, Market Development, Manufacturing Operations, Quality Assurance, SPC, Regulatory Affairs, Quality Control, Quality Management, Supplier Quality, Engineering Management, Six Sigma, Technology Transfer, Life Sciences, SolidWorks
Education
Columbia University - Columbia Business School
MBA, Entrepreneurship/Entrepreneurial Studies
San Diego State University-California State University
BSME, Mechanical Engieering
University of California, Berkeley - Walter A. Haas School of Business
Master of Business Administration (MBA), Entrepreneurship
Claudio Argento's Sadra Medical Experience May 2004 - September 2006
Job Vice President of Research and Development at Apama Medical
Industry Medical Devices
Experience
Apama Medical December 2011 - Present
PowerVision Inc. April 2008 - June 2011
Bioventrix September 2006 - April 2008
Sadra Medical May 2004 - September 2006
Edwards Lifesciences 2000 - 2004
Rockwell Scientific 1996 - 2000
DuPont 1994 - 1996
Skills
ISO 13485, V&V, Medical Devices, CAPA, Biomedical Engineering, R&D, Design of Experiments, Design Control, Validation, FDA, Product Development, Commercialization, Quality System, ISO 14971, Design for Manufacturing, Manufacturing, Cross-functional Team...
Education
Université Joseph Fourier (Grenoble I) 1991 — 1994
Ph.D., Mechanical Engineering
Institut polytechnique de Grenoble 1990 — 1991
M.Sc., Mechanical Engineering
Pontifícia Universidade Católica do Rio de Janeiro 1984 — 1988
B.Sc., Mechanical Engineering
Apama Medical December 2011 - Present
PowerVision Inc. April 2008 - June 2011
Bioventrix September 2006 - April 2008
Sadra Medical May 2004 - September 2006
Edwards Lifesciences 2000 - 2004
Rockwell Scientific 1996 - 2000
DuPont 1994 - 1996
Skills
ISO 13485, V&V, Medical Devices, CAPA, Biomedical Engineering, R&D, Design of Experiments, Design Control, Validation, FDA, Product Development, Commercialization, Quality System, ISO 14971, Design for Manufacturing, Manufacturing, Cross-functional Team...
Education
Université Joseph Fourier (Grenoble I) 1991 — 1994
Ph.D., Mechanical Engineering
Institut polytechnique de Grenoble 1990 — 1991
M.Sc., Mechanical Engineering
Pontifícia Universidade Católica do Rio de Janeiro 1984 — 1988
B.Sc., Mechanical Engineering
Brian Placek's Sadra Medical Experience 2005 - 2007
Job Senior Engineer at Gynesonics
Industry Medical Devices
Experience
Gynesonics March 2007 - Present
Sadra Medical 2005 - 2007
Hantel Technologies, Inc. 2004 - 2005
Kellogg Company 1998 - 1999
Skills
Medical Devices, Design Control, Solidworks, Catheters, Product Development, Fixtures, Biomedical Engineering, Prototyping, Extrusion, Design for Manufacturing, Validation, Design of Experiments, FMEA, Quality System, R&D, FDA, Manufacturing, ISO 13485
Education
Stanford University 2000 — 2002
Master of Science, Mechanical Engineering
Kansas State University 1994 — 1999
Gynesonics March 2007 - Present
Sadra Medical 2005 - 2007
Hantel Technologies, Inc. 2004 - 2005
Kellogg Company 1998 - 1999
Skills
Medical Devices, Design Control, Solidworks, Catheters, Product Development, Fixtures, Biomedical Engineering, Prototyping, Extrusion, Design for Manufacturing, Validation, Design of Experiments, FMEA, Quality System, R&D, FDA, Manufacturing, ISO 13485
Education
Stanford University 2000 — 2002
Master of Science, Mechanical Engineering
Kansas State University 1994 — 1999
Lori Adels, Ph.D.'s Sadra Medical Experience 2005 - June 2009
Job Executive VP, Regulatory Affairs at The Experien Group
Industry Medical Devices
Experience
NeoChord August 2015 - Present
The Experien Group November 2012 - August 2015
Edwards Lifesciences June 2009 - November 2012
Sadra Medical 2005 - June 2009
AtriCure, Inc. June 2003 - June 2009
Strategic Regulatory Solutions January 2000 - June 2009
Crux Biomedical 2007 - 2008
APTUS 2003 - 2007
Smart Therapeutics 2001 - 2002
EndoVascular Technologies 1992 - 1999
Skills
FDA, Medical Devices, Clinical Research, Regulatory Submissions, Start-ups, Quality Assurance, Strategic Planning, Biomedical Engineering, ISO 13485, Biotechnology, Clinical Trials, Lifesciences, Design Control, Commercialization, Surgery, Cardiology, Product Development, Clinical Data Management, Vascular, Market Development, Hospitals, Cross-functional Team..., GCP, Healthcare, Regulatory Affairs, CAPA, Quality System, Validation, Product Launch, Clinical Development, R&D, V&V, Strategy, 21 CFR Part 11, CRO, CTMS, Capital Equipment, GMP, Hardware Diagnostics, ISO 14971, Oncology, Orthopedic, Pharmaceutical Industry, Sop, Technology Transfer
Education
University of California, Irvine 1980 — 1985
Ph.D., Neuroscience
University of Pennsylvania 1976 — 1980
BA, Biology
Stuyvesant HS 1972 — 1976
NeoChord August 2015 - Present
The Experien Group November 2012 - August 2015
Edwards Lifesciences June 2009 - November 2012
Sadra Medical 2005 - June 2009
AtriCure, Inc. June 2003 - June 2009
Strategic Regulatory Solutions January 2000 - June 2009
Crux Biomedical 2007 - 2008
APTUS 2003 - 2007
Smart Therapeutics 2001 - 2002
EndoVascular Technologies 1992 - 1999
Skills
FDA, Medical Devices, Clinical Research, Regulatory Submissions, Start-ups, Quality Assurance, Strategic Planning, Biomedical Engineering, ISO 13485, Biotechnology, Clinical Trials, Lifesciences, Design Control, Commercialization, Surgery, Cardiology, Product Development, Clinical Data Management, Vascular, Market Development, Hospitals, Cross-functional Team..., GCP, Healthcare, Regulatory Affairs, CAPA, Quality System, Validation, Product Launch, Clinical Development, R&D, V&V, Strategy, 21 CFR Part 11, CRO, CTMS, Capital Equipment, GMP, Hardware Diagnostics, ISO 14971, Oncology, Orthopedic, Pharmaceutical Industry, Sop, Technology Transfer
Education
University of California, Irvine 1980 — 1985
Ph.D., Neuroscience
University of Pennsylvania 1976 — 1980
BA, Biology
Stuyvesant HS 1972 — 1976
Sue Vican's Sadra Medical Experience 2000 - 2007
Job CFO Consultant for StartUps
Industry Medical Devices
Experience
Epiphany Biosciences 2007 - 2009
Capton Inc April 2004 - 2009
Sadra Medical 2000 - 2007
EoPlex Technologies 1999 - 2003
Nellix Inc 1999 - 2003
Syneon LLC 1999 - 2003
Corazon Technologies 1998 - 1999
Cardiothoracic Systems 1994 - 1996
American Life Support Technology 1992 - 1993
Robertson Stephens & Co 1986 - 1992
Skills
Strategic Planning, Medical Devices
Education
University of California, Berkeley, Haas School of Business 1976 — 1978
Portland State University 1970 — 1976
BA, French
Epiphany Biosciences 2007 - 2009
Capton Inc April 2004 - 2009
Sadra Medical 2000 - 2007
EoPlex Technologies 1999 - 2003
Nellix Inc 1999 - 2003
Syneon LLC 1999 - 2003
Corazon Technologies 1998 - 1999
Cardiothoracic Systems 1994 - 1996
American Life Support Technology 1992 - 1993
Robertson Stephens & Co 1986 - 1992
Skills
Strategic Planning, Medical Devices
Education
University of California, Berkeley, Haas School of Business 1976 — 1978
Portland State University 1970 — 1976
BA, French
Robert Chang's Sadra Medical Experience September 2009 - January 2011
Job CoFounder, President & CEO at MVRx, Inc.
Industry Medical Devices
Experience
MVRx, Inc. October 2013 - Present
Technology Development Consultant September 2013 - Present
Boston Scientific Structural Heart January 2011 - September 2013
Sadra Medical September 2009 - January 2011
Ample Medical March 2002 - June 2009
Satiety October 2000 - October 2001
IsoStent July 1995 - December 2000
Devices for Vascular Intervention 1991 - 1995
Education
Massachusetts Institute of Technology 1986 — 1988
SM
Cal Poly 1982 — 1986
BS
MVRx, Inc. October 2013 - Present
Technology Development Consultant September 2013 - Present
Boston Scientific Structural Heart January 2011 - September 2013
Sadra Medical September 2009 - January 2011
Ample Medical March 2002 - June 2009
Satiety October 2000 - October 2001
IsoStent July 1995 - December 2000
Devices for Vascular Intervention 1991 - 1995
Education
Massachusetts Institute of Technology 1986 — 1988
SM
Cal Poly 1982 — 1986
BS
Rob Geshlider's Sadra Medical Experience 2003 - 2007
Job Director of Technical Innovation at LIM Innovations
Industry Design
Experience
LIM Innovations November 2013 - Present
Emerging Objects Corp. April 2013 - Present
CometX November 2012 - Present
Peak Solutions LLC October 2008 - October 2012
Sadra Medical 2003 - 2007
Syneon LLC June 1999 - June 2002
Custom Medical Models July 1993 - May 2000
Skills
Rapid Prototyping, Manufacturing, CAD/CAM, Solidworks, Design for Manufacturing, Product Design, CAD, R&D, Product Development, Medical Devices, Injection Molding, Mechanical Engineering, Manufacturing..., 3D Scanning, 3D, 3D Printing, Engineering Management, Modeling
Education
Pratt Institute 1980 — 1985
Bachelor of Fine Arts (BFA)
Oberlin College 1976 — 1977
LIM Innovations November 2013 - Present
Emerging Objects Corp. April 2013 - Present
CometX November 2012 - Present
Peak Solutions LLC October 2008 - October 2012
Sadra Medical 2003 - 2007
Syneon LLC June 1999 - June 2002
Custom Medical Models July 1993 - May 2000
Skills
Rapid Prototyping, Manufacturing, CAD/CAM, Solidworks, Design for Manufacturing, Product Design, CAD, R&D, Product Development, Medical Devices, Injection Molding, Mechanical Engineering, Manufacturing..., 3D Scanning, 3D, 3D Printing, Engineering Management, Modeling
Education
Pratt Institute 1980 — 1985
Bachelor of Fine Arts (BFA)
Oberlin College 1976 — 1977
Michael Calomeni's Sadra Medical Experience July 2008 - Present
Job Student at Santa Clara University
Industry Mechanical or Industrial Engineering
Experience
Sadra Medical July 2008 - Present
Education
Santa Clara University 2007 — 2010
Sadra Medical July 2008 - Present
Education
Santa Clara University 2007 — 2010
Drewz Phan's Sadra Medical Experience July 2009 - Present
Job at Sadra Medical
Industry Medical Devices
Experience
Boston Scientific Corporation- Structural Heart (BSC-SH)- Formerly Sadra Medical July 2009 - Present
Sadra Medical July 2009 - Present
Sinexus Inc August 2008 - May 2009
FoxHollow Technologies, Inc January 2008 - July 2008
FoxHollow Technologies, Inc December 2003 - January 2008
Abbott Diagnostic June 1995 - January 2001
Skills
Quality Assurance, Manufacturing, Medical Devices, Quality System, Quality Control, CAPA, Testing, Validation, Root Cause Analysis, R&D
Education
Institute for Business Performance San Jose State University
General Education
San Jose State University
Boston Scientific Corporation- Structural Heart (BSC-SH)- Formerly Sadra Medical July 2009 - Present
Sadra Medical July 2009 - Present
Sinexus Inc August 2008 - May 2009
FoxHollow Technologies, Inc January 2008 - July 2008
FoxHollow Technologies, Inc December 2003 - January 2008
Abbott Diagnostic June 1995 - January 2001
Skills
Quality Assurance, Manufacturing, Medical Devices, Quality System, Quality Control, CAPA, Testing, Validation, Root Cause Analysis, R&D
Education
Institute for Business Performance San Jose State University
General Education
San Jose State University
Jason Ozaeta's Sadra Medical Experience June 2008 - September 2008
Job Quality Engineer
Industry Medical Devices
Experience
Sadra Medical June 2008 - September 2008
Cal Poly State University September 2003 - December 2007
Skills
Micro-Vu, Programming, Quality Inspection, Mechanical Testing, Calibration, Equipment Management, Documentation, Solidworks, Quality Control, Software Documentation, Cleanroom validation, Environmental Monitoring, ISO 14644, External Audit, ISO, Manufacturing, Medical Devices, CAPA
Education
California Polytechnic State University-San Luis Obispo 2002 — 2008
M.S, B.S, Biomedical Engineering
Sadra Medical June 2008 - September 2008
Cal Poly State University September 2003 - December 2007
Skills
Micro-Vu, Programming, Quality Inspection, Mechanical Testing, Calibration, Equipment Management, Documentation, Solidworks, Quality Control, Software Documentation, Cleanroom validation, Environmental Monitoring, ISO 14644, External Audit, ISO, Manufacturing, Medical Devices, CAPA
Education
California Polytechnic State University-San Luis Obispo 2002 — 2008
M.S, B.S, Biomedical Engineering
Raj Khokhar's Sadra Medical Experience September 2005 - February 2009
Job Engineer at Sadra Medical
Industry Medical Devices
Experience
Sadra Medical September 2005 - February 2009
sadra medical 2005 - 2009
Boston Scientific 2002 - 2005
Education
San Diego State University-California State University 1993 — 1995
BS
Sadra Medical September 2005 - February 2009
sadra medical 2005 - 2009
Boston Scientific 2002 - 2005
Education
San Diego State University-California State University 1993 — 1995
BS
Robert Zytkewicz's Sadra Medical Experience 2006 - 2008
Job Principal Engineer at Direct Flow Medical
Industry Medical Devices
Experience
Direct Flow Medical November 2008 - Present
Hansen Medical February 2008 - October 2008
Sadra Medical 2006 - 2008
Edwards Lifesciences 1990 - 2005
Skills
Medical Devices, Manufacturing, Quality System, Product Development, FDA, Start-ups, Biomedical Engineering, Design Control, ISO 13485, Validation, CAPA, Commercialization, Design of Experiments, Solidworks, Catheters
Education
California State University-Fullerton
Mechanical Engineering
Direct Flow Medical November 2008 - Present
Hansen Medical February 2008 - October 2008
Sadra Medical 2006 - 2008
Edwards Lifesciences 1990 - 2005
Skills
Medical Devices, Manufacturing, Quality System, Product Development, FDA, Start-ups, Biomedical Engineering, Design Control, ISO 13485, Validation, CAPA, Commercialization, Design of Experiments, Solidworks, Catheters
Education
California State University-Fullerton
Mechanical Engineering
Crissly Crisostomo's Sadra Medical Experience February 2010 - Present
Job R&D Engineer at Sadra Medical
Industry Medical Devices
Experience
Sadra Medical February 2010 - Present
Arbor Surgical June 2006 - January 2010
Arbor Surgical Technologies June 2006 - January 2010
Flex Partners January 2005 - May 2005
Education
San Diego State University-California State University 2000 — 2005
BS, Biology/ Bioengineering
Sadra Medical February 2010 - Present
Arbor Surgical June 2006 - January 2010
Arbor Surgical Technologies June 2006 - January 2010
Flex Partners January 2005 - May 2005
Education
San Diego State University-California State University 2000 — 2005
BS, Biology/ Bioengineering
Amr Salahieh's Sadra Medical Experience 2003 - 2007
Job President & CEO at Shifamed LLC
Industry Medical Devices
Experience
Shifamed LLC January 2008 - Present
Apama Medical February 2009 - Present
Maya Medical June 2010 - January 2013
AtheroMed, Inc. 2007 - 2007
Sadra Medical 2003 - 2007
Boston Scientific 2000 - 2004
Embolic Protection Inc 1999 - 2000
Sobek Medical LLC 1995 - 1999
EndoTex Interventional Systems 1996 - 1997
CardioThoracic Systems 1995 - 1997
Skills
Medical Devices, Commercialization, Biomedical Engineering, Biotechnology, Product Development, Hardware Diagnostics, Start-ups, R&D, Catheters
Education
Case Western Reserve University 1984 — 1989
BS, Biomedical Engineering/Electrical Engineering
Shifamed LLC January 2008 - Present
Apama Medical February 2009 - Present
Maya Medical June 2010 - January 2013
AtheroMed, Inc. 2007 - 2007
Sadra Medical 2003 - 2007
Boston Scientific 2000 - 2004
Embolic Protection Inc 1999 - 2000
Sobek Medical LLC 1995 - 1999
EndoTex Interventional Systems 1996 - 1997
CardioThoracic Systems 1995 - 1997
Skills
Medical Devices, Commercialization, Biomedical Engineering, Biotechnology, Product Development, Hardware Diagnostics, Start-ups, R&D, Catheters
Education
Case Western Reserve University 1984 — 1989
BS, Biomedical Engineering/Electrical Engineering
Joshua Wallin's Sadra Medical Experience August 2010 - December 2011
Job Mechanincal Engineering Consultant Energy Medical Systems
Industry Medical Devices
Experience
Energy Medical Systems, LLC November 2013 - Present
Maya Medical / Covidien November 2011 - October 2013
Kalila Medical June 2011 - May 2012
Sadra Medical August 2010 - December 2011
Nanostim, Inc. October 2009 - August 2010
Paracor Medical, Inc. 2001 - 2009
Cardio Thoracic Systems, Inc. / Guidant Corp. 1998 - 2001
Hayes Medical, Inc. 1996 - 1998
Skills
Medical Devices, FDA, ISO 13485, Biomedical Engineering, Design Control, Design for Manufacturing, Manufacturing, Product Development, Engineering, R&D
Education
Rensselaer Polytechnic Institute 1992 — 1996
B.S., Biomedical Engineering - Concentration in Mechanical Design
Energy Medical Systems, LLC November 2013 - Present
Maya Medical / Covidien November 2011 - October 2013
Kalila Medical June 2011 - May 2012
Sadra Medical August 2010 - December 2011
Nanostim, Inc. October 2009 - August 2010
Paracor Medical, Inc. 2001 - 2009
Cardio Thoracic Systems, Inc. / Guidant Corp. 1998 - 2001
Hayes Medical, Inc. 1996 - 1998
Skills
Medical Devices, FDA, ISO 13485, Biomedical Engineering, Design Control, Design for Manufacturing, Manufacturing, Product Development, Engineering, R&D
Education
Rensselaer Polytechnic Institute 1992 — 1996
B.S., Biomedical Engineering - Concentration in Mechanical Design
Jeremy Boyette's Sadra Medical Experience June 2010 - April 2011
Job R&D Engineer at Maya Medical
Industry Mechanical or Industrial Engineering
Experience
Maya Medical April 2011 - Present
Sadra Medical June 2010 - April 2011
Sadra Medical June 2009 - June 2010
Education
Santa Clara University 2007 — 2010
BS, Mechanical Engineering
Maya Medical April 2011 - Present
Sadra Medical June 2010 - April 2011
Sadra Medical June 2009 - June 2010
Education
Santa Clara University 2007 — 2010
BS, Mechanical Engineering
Tonia Tsinman's Sadra Medical Experience June 2012 - August 2012
Job Research Technician (Cheeseman Lab) at Whitehead Institute
Industry Biotechnology
Experience
Whitehead Institute July 2013 - Present
MIT 2009 - 2013
Sadra Medical June 2012 - August 2012
TU Delft January 2012 - February 2012
Khademhosseini Lab January 2010 - December 2011
Boston Scientific May 2011 - August 2011
UCSF VA Medical Center January 2011 - February 2011
Pion Inc. May 2009 - August 2009
Skills
Mammalian Cell Culture, Fluorescence Microscopy, RAMAN Spectroscopy, UV Vis Spectroscopy, ELISA, Matlab, PCR and PCR primer..., Python, Solidworks, Western analysis, Flow Cytometry, Pymol
Education
Massachusetts Institute of Technology 2009 — 2013
Bachelor of Science, Biological Engineering
Whitehead Institute July 2013 - Present
MIT 2009 - 2013
Sadra Medical June 2012 - August 2012
TU Delft January 2012 - February 2012
Khademhosseini Lab January 2010 - December 2011
Boston Scientific May 2011 - August 2011
UCSF VA Medical Center January 2011 - February 2011
Pion Inc. May 2009 - August 2009
Skills
Mammalian Cell Culture, Fluorescence Microscopy, RAMAN Spectroscopy, UV Vis Spectroscopy, ELISA, Matlab, PCR and PCR primer..., Python, Solidworks, Western analysis, Flow Cytometry, Pymol
Education
Massachusetts Institute of Technology 2009 — 2013
Bachelor of Science, Biological Engineering
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY