Elixir Medical
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Elixir Medical Employees
Employee
Years
Job
Industry
Samit Mustafa Samit Mustafa's Elixir Medical Experience March 2014 - Present
Job R&D Engineer
Industry Biotechnology
Experience
Elixir Medical March 2014 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] March 2013 - February 2014
Abbott May 2012 - March 2013
Abbott May 2011 - September 2011
Abbott May 2010 - December 2010
Skills
Medical Devices, CAPA, Solidworks, ISO 13485, Microsoft office, Labview, Design of Experiments, Instron, Matlab, ANSYS, MIG welding, Manufacturing, Scanning Electron..., Milling, Lathe, Drill Press, FDA, JMP, Differencial Scanning..., New Product Validation, Test Method Validation, Root Cause Problem..., Lean Manufacturing, ASTM standards, Process Capability, Process Optimization, Laser Cutting, Polymer Characterization, Rapid Prototyping, Gage R&R, Tolerance Analysis, Product Specification, Crimping, Stent Design, Design Control, CAM
Education
New Jersey Institute of Technology 2011 — 2013
Master's degree, Biomedical Engineering (Biomaterial and Biomechanics Concentration)
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2010
Bachelor's degree, Mechanical Engineering
Elixir Medical March 2014 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] March 2013 - February 2014
Abbott May 2012 - March 2013
Abbott May 2011 - September 2011
Abbott May 2010 - December 2010
Skills
Medical Devices, CAPA, Solidworks, ISO 13485, Microsoft office, Labview, Design of Experiments, Instron, Matlab, ANSYS, MIG welding, Manufacturing, Scanning Electron..., Milling, Lathe, Drill Press, FDA, JMP, Differencial Scanning..., New Product Validation, Test Method Validation, Root Cause Problem..., Lean Manufacturing, ASTM standards, Process Capability, Process Optimization, Laser Cutting, Polymer Characterization, Rapid Prototyping, Gage R&R, Tolerance Analysis, Product Specification, Crimping, Stent Design, Design Control, CAM
Education
New Jersey Institute of Technology 2011 — 2013
Master's degree, Biomedical Engineering (Biomaterial and Biomechanics Concentration)
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2010
Bachelor's degree, Mechanical Engineering
Shawn Davis Shawn Davis's Elixir Medical Experience October 2014 - Present
Job Quality Manager at Elixir Medical
Industry Medical Devices
Experience
Elixir Medical October 2014 - Present
Abbott Vascular September 2009 - October 2014
Evalve, Inc. September 2009 - April 2011
Curexo Technology Corporation July 2008 - February 2009
Health Net December 2007 - July 2008
GE Healthcare November 2004 - December 2007
GE Healthcare June 2001 - November 2004
Skills
Six Sigma, Cross-functional Team..., Project Management, Quality System, Validation, CAPA, Testing, Leadership, FMEA, Team-oriented, FDA, ISO 13485, Continuous Improvement, Lean Manufacturing, Root Cause Analysis, Design Control, Organized Multi-tasker, Positive Personality, Medical Devices, Process Improvement, Product Development, Success Oriented, Integration, Software Development, Manufacturing, V&V, Engineering, Quality Control, Program Management, Quality Assurance, Customer Service, DMAIC, ISO 14971, Quality Auditing, Team Building, Strategic Leadership, Supplier Quality
Education
Milwaukee School of Engineering 1997 — 2001
Bachelor of Science, Computer Engineering
Elixir Medical October 2014 - Present
Abbott Vascular September 2009 - October 2014
Evalve, Inc. September 2009 - April 2011
Curexo Technology Corporation July 2008 - February 2009
Health Net December 2007 - July 2008
GE Healthcare November 2004 - December 2007
GE Healthcare June 2001 - November 2004
Skills
Six Sigma, Cross-functional Team..., Project Management, Quality System, Validation, CAPA, Testing, Leadership, FMEA, Team-oriented, FDA, ISO 13485, Continuous Improvement, Lean Manufacturing, Root Cause Analysis, Design Control, Organized Multi-tasker, Positive Personality, Medical Devices, Process Improvement, Product Development, Success Oriented, Integration, Software Development, Manufacturing, V&V, Engineering, Quality Control, Program Management, Quality Assurance, Customer Service, DMAIC, ISO 14971, Quality Auditing, Team Building, Strategic Leadership, Supplier Quality
Education
Milwaukee School of Engineering 1997 — 2001
Bachelor of Science, Computer Engineering
Lucas Fernandez Lucas Fernandez's Elixir Medical Experience October 2013 - Present
Job
Industry Medical Devices
Experience
Elixir Medical October 2013 - Present
Nanostim, Inc. July 2011 - October 2013
Stryker September 2010 - July 2011
Hotspur Technologies July 2009 - September 2010
Ostial Corp May 2008 - September 2010
Boston Scientific May 2007 - May 2008
Boston Scientific April 2005 - May 2007
Greenline Financial Technologies January 2005 - May 2005
SBC Communications July 2004 - December 2004
Agilent Technologies September 2002 - September 2003
Skills
Medical Devices, FDA, Validation, Quality Systems, Design Control, ISO 13485, Regulatory Submissions, Catheters, Stents, Pacemakers, Neurovascular, Cardiovascular Disease, CAPA, Quality System, Risk Management, ISO 14971, R&D, Manufacturing, Root Cause Analysis, ISO, Gage R&R, Process Simulation, Quality Assurance, Management, Leadership, 21 CFR, Supplier Quality, Product Development, Quality Control, Cross-functional Team...
Education
Stanford University 2003 — 2004
Master of Science
University of Oklahoma 1996 — 2000
Bachelors of Science
Costa Rica Academy 1992 — 1996
High School Diploma
Elixir Medical October 2013 - Present
Nanostim, Inc. July 2011 - October 2013
Stryker September 2010 - July 2011
Hotspur Technologies July 2009 - September 2010
Ostial Corp May 2008 - September 2010
Boston Scientific May 2007 - May 2008
Boston Scientific April 2005 - May 2007
Greenline Financial Technologies January 2005 - May 2005
SBC Communications July 2004 - December 2004
Agilent Technologies September 2002 - September 2003
Skills
Medical Devices, FDA, Validation, Quality Systems, Design Control, ISO 13485, Regulatory Submissions, Catheters, Stents, Pacemakers, Neurovascular, Cardiovascular Disease, CAPA, Quality System, Risk Management, ISO 14971, R&D, Manufacturing, Root Cause Analysis, ISO, Gage R&R, Process Simulation, Quality Assurance, Management, Leadership, 21 CFR, Supplier Quality, Product Development, Quality Control, Cross-functional Team...
Education
Stanford University 2003 — 2004
Master of Science
University of Oklahoma 1996 — 2000
Bachelors of Science
Costa Rica Academy 1992 — 1996
High School Diploma
Patty Hevey Patty Hevey's Elixir Medical Experience September 2007 - October 2008
Job Director of Clinical & Regulatory Affairs at Avinger Inc. (Acquired Sawooth Labs)
Industry Medical Devices
Experience
Avinger Inc. (Acquired Sawooth Labs) March 2011 - Present
Hevey Clinical Consultancy July 2010 - December 2011
Avinger, Inc. 2011 - 2011
Baxano, Inc. November 2008 - July 2010
Elixir Medical September 2007 - October 2008
Conor Medsystems (Cordis West, J&J) 2007 - 2008
Abbott Vascular 1998 - 2000
Skills
Medical Devices, Clinical Research
Education
The George Washington University School of Medicine and Health Sciences
Avinger Inc. (Acquired Sawooth Labs) March 2011 - Present
Hevey Clinical Consultancy July 2010 - December 2011
Avinger, Inc. 2011 - 2011
Baxano, Inc. November 2008 - July 2010
Elixir Medical September 2007 - October 2008
Conor Medsystems (Cordis West, J&J) 2007 - 2008
Abbott Vascular 1998 - 2000
Skills
Medical Devices, Clinical Research
Education
The George Washington University School of Medicine and Health Sciences
Auben Debus Auben Debus's Elixir Medical Experience June 2011 - September 2012
Job Clinical Research Manager at HeartFlow, Inc
Industry Medical Devices
Experience
Heartflow, Inc February 2015 - Present
Heartflow, Inc September 2013 - January 2015
Heartflow, Inc September 2012 - September 2013
Elixir Medical June 2011 - September 2012
Paracor Medical July 2007 - April 2011
California Association of Flower Growers & Shippers 2002 - 2007
Skills
FDA, Regulatory Affairs, Clinical Trials, Clinical Research, Medical Devices, ISO 13485, GCP, Regulatory Submissions, Validation, CTMS
Education
Mills College
MFA, English & Creative Writing
University of California, Davis
BA, English
Heartflow, Inc February 2015 - Present
Heartflow, Inc September 2013 - January 2015
Heartflow, Inc September 2012 - September 2013
Elixir Medical June 2011 - September 2012
Paracor Medical July 2007 - April 2011
California Association of Flower Growers & Shippers 2002 - 2007
Skills
FDA, Regulatory Affairs, Clinical Trials, Clinical Research, Medical Devices, ISO 13485, GCP, Regulatory Submissions, Validation, CTMS
Education
Mills College
MFA, English & Creative Writing
University of California, Davis
BA, English
Richard Gomes's Elixir Medical Experience September 2008 - April 2010
Job
Industry Management Consulting
Experience
Strategic Advisory Board February 2014 - Present
Timbuk2 April 2010 - January 2014
Elixir Medical September 2008 - April 2010
Boston Scientific August 2006 - September 2008
New Wave Research June 1998 - July 2006
Skills
Lean Manufacturing, Cross-functional Team..., Manufacturing, Continuous Improvement, Management, Product Development, Process Improvement, Quality System, Strategic Sourcing, Supply Chain, Supply Chain Management, Industrial Engineering, Procurement, ERP, Purchasing, ISO, Medical Devices, Sop, Kaizen, Project Management, FDA, CAPA, Manufacturing Operations, Strategy, Leadership, Business Process Mapping, Forecasting, GMP, Inventory Control, Supplier Development, Laser, Production Planning, Project Planning, Food & Beverage, Food Processing, Distribution Logistics, Food Industry, Warehouse Management, Warehouse Control, Consumer Goods, Industrial Sewing, 5S, Leadership Development, Cross Cultural..., Strategic Planning, Training & Development, Machinery, Capital Equipment, Production Management, Contract Manufacturing
Education
San Jose State University 1996 — 2002
BS
Strategic Advisory Board February 2014 - Present
Timbuk2 April 2010 - January 2014
Elixir Medical September 2008 - April 2010
Boston Scientific August 2006 - September 2008
New Wave Research June 1998 - July 2006
Skills
Lean Manufacturing, Cross-functional Team..., Manufacturing, Continuous Improvement, Management, Product Development, Process Improvement, Quality System, Strategic Sourcing, Supply Chain, Supply Chain Management, Industrial Engineering, Procurement, ERP, Purchasing, ISO, Medical Devices, Sop, Kaizen, Project Management, FDA, CAPA, Manufacturing Operations, Strategy, Leadership, Business Process Mapping, Forecasting, GMP, Inventory Control, Supplier Development, Laser, Production Planning, Project Planning, Food & Beverage, Food Processing, Distribution Logistics, Food Industry, Warehouse Management, Warehouse Control, Consumer Goods, Industrial Sewing, 5S, Leadership Development, Cross Cultural..., Strategic Planning, Training & Development, Machinery, Capital Equipment, Production Management, Contract Manufacturing
Education
San Jose State University 1996 — 2002
BS
Gary Castro Gary Castro's Elixir Medical Experience July 2012 - December 2013
Job CFO at Lazarus Effect
Industry Medical Devices
Experience
Medtronic Minimally Invasive Therapies Group October 2014 - Present
Lazarus Effect July 2014 - Present
Elixir Medical July 2012 - December 2013
IntraPace March 2008 - July 2012
M2 Medical June 2006 - November 2007
Avantec Vascular April 2002 - May 2006
HIH America September 1998 - June 2001
GT Global/LGT Asset Mgmt February 1995 - August 1998
Arthur Andersen July 1990 - January 1995
Education
Stanford University 1984 — 1990
BA/MA
Ludwig-Maximilians Universität München 1988 — 1989
Medtronic Minimally Invasive Therapies Group October 2014 - Present
Lazarus Effect July 2014 - Present
Elixir Medical July 2012 - December 2013
IntraPace March 2008 - July 2012
M2 Medical June 2006 - November 2007
Avantec Vascular April 2002 - May 2006
HIH America September 1998 - June 2001
GT Global/LGT Asset Mgmt February 1995 - August 1998
Arthur Andersen July 1990 - January 1995
Education
Stanford University 1984 — 1990
BA/MA
Ludwig-Maximilians Universität München 1988 — 1989
Howard Huang's Elixir Medical Experience May 2012 - Present
Job
Industry Medical Devices
Experience
Elixir Medical May 2012 - Present
Skills
FDA, Medical Devices, GMP, Catheters, V&V, R&D, Cross-functional Team..., Commercialization
Education
Massachusetts Institute of Technology 1993 — 1997
Elixir Medical May 2012 - Present
Skills
FDA, Medical Devices, GMP, Catheters, V&V, R&D, Cross-functional Team..., Commercialization
Education
Massachusetts Institute of Technology 1993 — 1997
Gino Kang's Elixir Medical Experience April 2009 - January 2010
Job Program Director at Elixir Medical
Industry Medical Devices
Experience
Ivera Medical January 2010 - Present
Elixir Medical April 2009 - January 2010
Biosensors Int 2004 - April 2009
Avail Medical 2002 - 2004
Cardionet, Inc. 1999 - 2003
McGaw 1996 - 1998
Skills
Medical Devices, Product Launch, Manufacturing, Quality System, FDA, ISO 13485, Product Development, CAPA, GMP, Design Control, Cross-functional Team..., Validation, Project Management, R&D, Management
Education
University of California, San Diego 1982 — 1988
Ivera Medical January 2010 - Present
Elixir Medical April 2009 - January 2010
Biosensors Int 2004 - April 2009
Avail Medical 2002 - 2004
Cardionet, Inc. 1999 - 2003
McGaw 1996 - 1998
Skills
Medical Devices, Product Launch, Manufacturing, Quality System, FDA, ISO 13485, Product Development, CAPA, GMP, Design Control, Cross-functional Team..., Validation, Project Management, R&D, Management
Education
University of California, San Diego 1982 — 1988
Irina Astafieva, PhD's Elixir Medical Experience March 2008 - April 2010
Job Director, Preclinical Development at ForSight Vision
Industry Medical Devices
Experience
ForSight Vision September 2011 - Present
Acclarent May 2010 - September 2011
Elixir Medical March 2008 - April 2010
Abbott Vascular 2006 - 2008
Abbott Vascular 2005 - 2007
Guidant 2002 - 2005
Coulter Pharmaceutical / Corixa Corp 1998 - 2001
Education
McGill University 1992 — 1993
post-doctoral, drug delivery
Lomonosov Moscow State University (MSU)
Doctor of Philosophy (PhD), Polymer Chemistry
ForSight Vision September 2011 - Present
Acclarent May 2010 - September 2011
Elixir Medical March 2008 - April 2010
Abbott Vascular 2006 - 2008
Abbott Vascular 2005 - 2007
Guidant 2002 - 2005
Coulter Pharmaceutical / Corixa Corp 1998 - 2001
Education
McGill University 1992 — 1993
post-doctoral, drug delivery
Lomonosov Moscow State University (MSU)
Doctor of Philosophy (PhD), Polymer Chemistry
Daisy Nhan's Elixir Medical Experience December 2008 - Present
Job Sr. Mfg Technician at Elixir Medical
Industry Medical Devices
Experience
Elixir Medical December 2008 - Present
PulmonX July 2008 - November 2008
ev3 /Foxhollow Technologies Inc. August 2005 - June 2008
FoxHollow Technologies November 2002 - August 2005
Guidant/Origin September 1997 - August 2002
Skills
Medical Devices
Education
City College of San Francisco
Elixir Medical December 2008 - Present
PulmonX July 2008 - November 2008
ev3 /Foxhollow Technologies Inc. August 2005 - June 2008
FoxHollow Technologies November 2002 - August 2005
Guidant/Origin September 1997 - August 2002
Skills
Medical Devices
Education
City College of San Francisco
Adam Shively's Elixir Medical Experience August 2013 - Present
Job Director of Quality Assurance at Elixir Medical
Industry Medical Devices
Experience
Elixir Medical August 2013 - Present
Home Dialysis Plus, Limited June 2012 - July 2013
ReVascular Therapeutics (aquired by Boston Scientific) January 2010 - January 2012
ProMedical February 2009 - December 2009
Cordis July 2006 - February 2009
Ensure Medical 2003 - 2006
Endovasix 1999 - 2003
Accuray 1997 - 1999
Cardio Thorasic System 1995 - 1997
Skills
Medical Devices, Design Control, ISO 13485, CAPA, FDA, V&V, ISO 14971, Quality System, CE marking, Supplier Quality, Validation, GMP, Sop, ISO, Product Development, 21 CFR Part 11, SOP
Education
Montana State University-Bozeman 1985 — 1989
BS, Electrical Engineering
Elixir Medical August 2013 - Present
Home Dialysis Plus, Limited June 2012 - July 2013
ReVascular Therapeutics (aquired by Boston Scientific) January 2010 - January 2012
ProMedical February 2009 - December 2009
Cordis July 2006 - February 2009
Ensure Medical 2003 - 2006
Endovasix 1999 - 2003
Accuray 1997 - 1999
Cardio Thorasic System 1995 - 1997
Skills
Medical Devices, Design Control, ISO 13485, CAPA, FDA, V&V, ISO 14971, Quality System, CE marking, Supplier Quality, Validation, GMP, Sop, ISO, Product Development, 21 CFR Part 11, SOP
Education
Montana State University-Bozeman 1985 — 1989
BS, Electrical Engineering
Erin Mazzone's Elixir Medical Experience January 2012 - Present
Job Senior Director, Regulatory Affairs at Elixir Medical
Industry Medical Devices
Experience
Elixir Medical January 2012 - Present
MAQUET Cardiovascular November 2008 - January 2012
MAQUET Cardiovascular January 2008 - November 2008
Guidant Cardiac Surgery 2004 - 2008
RITA Medical Systems November 2003 - January 2004
RITA Medical Systems June 1999 - November 2003
Cardiac Pathways June 1997 - June 1999
Cardiometrics July 1996 - June 1997
Cardiac Pathways January 1995 - July 1996
Accuray August 1993 - December 1994
Skills
Design Control, Medical Devices, CAPA, Regulatory Affairs, Quality System, FDA, PMA, V&V, ISO 13485, ISO 14971, Clinical Trials, Biomaterials, Surgery, Product Development, Catheters, Clinical Research, Biomedical Engineering
Education
University of California, San Diego 1988 — 1993
BS, Bioengineering
Elixir Medical January 2012 - Present
MAQUET Cardiovascular November 2008 - January 2012
MAQUET Cardiovascular January 2008 - November 2008
Guidant Cardiac Surgery 2004 - 2008
RITA Medical Systems November 2003 - January 2004
RITA Medical Systems June 1999 - November 2003
Cardiac Pathways June 1997 - June 1999
Cardiometrics July 1996 - June 1997
Cardiac Pathways January 1995 - July 1996
Accuray August 1993 - December 1994
Skills
Design Control, Medical Devices, CAPA, Regulatory Affairs, Quality System, FDA, PMA, V&V, ISO 13485, ISO 14971, Clinical Trials, Biomaterials, Surgery, Product Development, Catheters, Clinical Research, Biomedical Engineering
Education
University of California, San Diego 1988 — 1993
BS, Bioengineering
Andrew Kramer's Elixir Medical Experience 2008 - Present
Job VP, Operations at Elixir Medical
Industry Medical Devices
Experience
Elixir Medical 2008 - Present
Apneon 2006 - 2008
Avantec Vascular 2002 - 2006
Pavier 2000 - 2002
Cardiogenesis 1996 - 2000
Skills
ISO 13485, Manufacturing, R&D, Quality System, V&V, Medical Devices, CAPA, Cross-functional Team..., Design Control, FDA
Education
University of California, San Diego
BSME
Elixir Medical 2008 - Present
Apneon 2006 - 2008
Avantec Vascular 2002 - 2006
Pavier 2000 - 2002
Cardiogenesis 1996 - 2000
Skills
ISO 13485, Manufacturing, R&D, Quality System, V&V, Medical Devices, CAPA, Cross-functional Team..., Design Control, FDA
Education
University of California, San Diego
BSME
Israel Corpuz's Elixir Medical Experience 2008 - 2008
Job Quality Assurance Technician III at Pulmonx Inc.
Industry Medical Devices
Experience
Pulmonx Inc. February 2009 - Present
FoxHollow Technologies September 2004 - June 2008
Elixir Medical 2008 - 2008
Cardio Vention February 2002 - August 2002
Guidant Corporation November 1997 - December 2000
Skills
ISO 13485, Medical Devices, V&V, Quality System, Validation, R&D, Quality Assurance, GMP, Biotechnology, Manufacturing, Design of Experiments, Product Development, Design Control
Education
Boston Reed 2002 — 2003
Licensed Pharmacy Technician (LIC# 50496), Pharmaceutical
Evergreen Valley College 1999 — 2001
Computer Programming
Pulmonx Inc. February 2009 - Present
FoxHollow Technologies September 2004 - June 2008
Elixir Medical 2008 - 2008
Cardio Vention February 2002 - August 2002
Guidant Corporation November 1997 - December 2000
Skills
ISO 13485, Medical Devices, V&V, Quality System, Validation, R&D, Quality Assurance, GMP, Biotechnology, Manufacturing, Design of Experiments, Product Development, Design Control
Education
Boston Reed 2002 — 2003
Licensed Pharmacy Technician (LIC# 50496), Pharmaceutical
Evergreen Valley College 1999 — 2001
Computer Programming
Helen Prince's Elixir Medical Experience August 2005 - Present
Job Quality Systems Consultant for Medical Devices
Industry Medical Devices
Experience
Elixir Medical August 2005 - Present
Guidant 2003 - 2004
Guidant 2000 - 2003
Advanced Cardiovascular Systems 1994 - 1997
Skills
Cross-functional Team..., Quality System, ISO 13485, ISO 14971, Validation, FDA, Medical Devices, Design Control, CAPA, FMEA, Manufacturing, V&V, Root Cause Analysis, DMAIC, R&D, Biomedical Engineering, Design of Experiments, Product Development
Education
Loughborough University 1988 — 1992
BEng, Maufacturing Engineering
Elixir Medical August 2005 - Present
Guidant 2003 - 2004
Guidant 2000 - 2003
Advanced Cardiovascular Systems 1994 - 1997
Skills
Cross-functional Team..., Quality System, ISO 13485, ISO 14971, Validation, FDA, Medical Devices, Design Control, CAPA, FMEA, Manufacturing, V&V, Root Cause Analysis, DMAIC, R&D, Biomedical Engineering, Design of Experiments, Product Development
Education
Loughborough University 1988 — 1992
BEng, Maufacturing Engineering