Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.]
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Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] Employees
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] March 2014 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] January 2012 - March 2014
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] August 2007 - December 2011
W. L. Gore & Associates October 2005 - August 2007
Spectranetics January 2002 - October 2005
Skills
Medical Devices, Capital Equipment, Market Development, Product Launch, Cardiology, Vascular, Operating Room, Cath Lab, Sales, Interventional..., Surgeons, Cross-functional Team..., CAPA, FDA, Product Development, Quality System, Disposables, Clinical Research, Commercialization
Education
University of St. Francis 1999 — 2001
Bachelor of Arts (B.A.), Health Arts
Indiana University-Northwest 1984 — 1986
Associate of Science (A.S.), Radiologic Sciences
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
Proteus Digital Health, Inc 2014 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] 2014 - 2014
Abbott Vascular 2011 - 2013
Abbott Vascular 2008 - 2011
Abbott Vascular 2007 - 2008
Abbott Vascular/ formerly Guidant 2005 - 2007
Guidant 2001 - 2005
Skills
PMP Certified, Agile Project..., DOE, iQ Stage Gate, PMP, Design of Experiments, Medical Devices, Design Control, ISO 13485, Quality System, Biomedical Engineering, Commercialization, Product Development, V&V, R&D, FDA, Cross-functional Team..., Validation, CAPA
Education
University of Arizona
Bachelor's Degree
Car dealership February 2014 - October 2014
Westech College July 2013 - January 2014
Buffalo Wild Wings September 2010 - August 2012
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] October 2008 - May 2010
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Teamwork, Photoshop, Social Media, Public Speaking, C++, English
Education
Westech College 2013 — 2014
Diploma, Computerize office
west valley High school 1999 — 2002
Diploma, General Education
Abbott Vascular Structural Heart May 2010 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] September 2009 - May 2010
WAGIC, Inc. September 2008 - November 2009
Abbott Vascular February 2008 - September 2008
Smart Products and Inventions 2004 - 2007
BC Tech January 2004 - June 2004
Parallax Medical 2002 - 2004
Specialized Bicycle Components 2001 - 2002
Trek Bicycles 1999 - 2001
Easton Bell Sports 1996 - 1999
Skills
Manufacturing..., Industrial Design, Design Control, ISO 13485, Medical Devices, FDA, CAPA, Validation, V&V, Quality System, R&D, Manufacturing, FMEA, Design of Experiments, Injection Molding, Design for Manufacturing, Continuous Improvement, Minitab, Six Sigma, DMAIC, Root Cause Analysis, SPC, CAD, ISO, Solidworks, Plastics, Cross-functional Team..., ISO 14971, GMP, Process Simulation, Change Control, 21 CFR Part 11, Supplier Quality, Quality Auditing, Testing, Quality Control, Engineering, Quality Management, Lean Manufacturing, Calibration, Quality Assurance, Iso 9000, Process Improvement, Catheters
Education
University of California, Santa Barbara 1991 — 1994
BS, Mechanical Engineering
SCHS 1985 — 1989
High School Diploma, Calculus and other pre-engineering studies.
Abbott Vascular October 2014 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] December 2013 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] June 2013 - December 2013
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] April 2012 - June 2013
Abbott Vascular April 2009 - April 2012
Abbott Vascular October 2008 - April 2009
Skills
Commercial Lines, Risk Assessment, Department Budgeting, Validation, Yields, Drug Eluting Stents, Implants, Nitinol, Quality Assurance, Manufacturing..., FDA, V, Quality Control, CAPA, Design Control, Manufacturing, ISO 13485, Medical Devices, Quality System, Cross-functional Team..., GMP
Education
Morgan State University
BS, Industrial Engineering
Planet Labs November 2014 - Present
Clif Bar & Company November 2014 - Present
Occipital December 2013 - November 2014
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] September 2011 - November 2013
Abbott September 2009 - August 2011
The Ohio State University September 2008 - August 2009
Abbott June 2008 - September 2008
Skills
SAP, Essbase, Variance Analysis, Microsoft Excel, Cost Accounting, Financial Forecasting, Finance, Internal Controls, Reporting & Analysis, Financial Audits, COGS, Standard Costs, Accounts Payable, Accounts Receivable, ADP Payroll, Netsuite, Concur, QuickBooks, 409A, Sales & Use Tax, 1099 Preparation, Cash Flow Analysis, Cash Flow Forecasting, Hyperion HFM, Microsoft Office, Oracle, Hyperion Planning, BPCS
Education
The Ohio State University 2009 — 2009
Master's degree, Accounting
The Ohio State University 2004 — 2008
Bachelor of Science (BS), Finance, General
Medical Device Startups May 2014 - July 2015
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] October 2013 - April 2014
Incumedx April 2012 - April 2013
Stryker August 2009 - March 2012
Boston Scientific August 2009 - December 2010
Biomerix Corporation September 2007 - July 2009
Embolic Protection Inc. - Boston Scientific September 2004 - September 2007
Aradigm Corporation April 2003 - July 2003
The Neurosciences Institute January 2003 - July 2003
Skills
R&D, Product Development, FDA, Validation, Design Control, Biomedical Engineering, ISO 13485, Medical Devices, Design of Experiments, V&V, Biomaterials, CAPA, Minitab, Quality System, ISO 14971, Product Design, Solidworks, Catheters, FMEA, Design for Manufacturing, GMP, Medical Device R&D, Regulatory Affairs, Stents, 21 CFR, Commercialization, Gage R&R, CE marking
Education
University of California, San Diego 1999 — 2003
Bachelors of Sciences, Bioengineering
Carlmont 1995 — 1999
Element Science, Inc. May 2015 - Present
Pulmonx March 2014 - May 2015
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] April 2011 - February 2014
Abbott Vascular International August 2008 - April 2011
Abbott Vascular International December 2006 - August 2008
Guidant Corp / Abbott April 2002 - December 2006
Guidant Corp / Abbott September 1998 - April 2002
Skills
Cross-functional Team..., Clinical Trials, Regulatory Affairs, Market Development, Cardiology, Product Launch, Product Management
Education
Georgia Institute of Technology 1996 — 1998
Master of Science (M.S.), Mechanical Engineering
The University of Texas at Austin 1992 — 1996
Bachelor of Science (B.S.), Mechanical Engineering
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] September 2014 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] May 2014 - August 2014
Abbott May 2012 - May 2014
Abbott Vascular January 2010 - May 2012
Abbott July 2009 - December 2009
Abbott January 2009 - June 2009
Abbott July 2008 - December 2008
Abbott Laboratories January 2008 - June 2008
Skills
Analysis, Biomedical Engineering, Budgets, CAPA, Chemical Engineering, Chemistry, Commissioning, Continuous Improvement, Cross-functional Team..., DMAIC, Design Control, Design of Experiments, Engineering, FDA, GLP, GMP, Human Resources, ISO, ISO 13485, Inspection, Leadership, Lean Manufacturing, Manufacturing, Management, Manufacturing..., Materials, Minitab, Operational Excellence, Process Improvement, Process Simulation, Product Development, Process Engineering, Pharmaceutical Industry, Quality Assurance, Project Management, Product Management, Quality Management, Quality Control, Quality Auditing, Root Cause Analysis, Quality System, Start-ups, Sop, Six Sigma, Testing, Supplier Quality, Strategy, Training, V, Validation
Education
Universidad de Puerto Rico 2003 — 2007
Bachelor's Degree, Chemical Engineering
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] July 2013 - Present
Intersect ENT June 2012 - December 2012
GE Aviation June 2011 - August 2011
FD Unlimited June 2010 - August 2010
Skills
Lathe, Solidworks, LaTeX, Microsoft Office, Fast Learner, CNC Mill, Simulink, Matlab, Machine Tools, Mechanical Engineering, Metal Fabrication, Milling, Labview, EES, Instron, R&D, Design for Manufacturing
Education
Santa Clara University 2008 — 2012
BS, Mechanical Engineering
Imperial College London 2010 — 2010
The Carlstar Group August 2014 - August 2015
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] 2009 - 2013
NUMMI 2008 - 2008
Concessions International Inc. 2007 - 2007
Education
University of California, Berkeley 2013 — 2014
California Polytechnic State University-San Luis Obispo 2002 — 2008
BS
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] April 2015 - Present
Boston Scientific August 2014 - March 2015
Medtronic Ablation Frontiers LLC 2009 - July 2014
Ablation Frontiers April 2007 - June 2009
Skills
Design Control, R&D, Medical Devices, Biomedical Engineering, ISO 13485, FDA, Engineering, ISO 14971, Design of Experiments, Root Cause Analysis, CAPA, Project management,..., SolidWorks, MiniTAB,..., Protocols & Reports,..., Characterization..., Familiarity with FDA..., ISO 13485, ISO 14971,..., Confidence intervals,..., Distribution analysis,..., Coordinate design and..., FMEA, Minitab, Biomaterials, V, Validation
Education
University of California, San Diego 2003 — 2006
MS, Bioengineering
University of California, Davis 1999 — 2003
BS, Biological System engineering
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] January 2009 - Present
Boston Scientific October 2006 - January 2009
LifeScan, Inc Johnson and Johnson September 2005 - October 2006
Becton Dickinson Immunocytometry Systems October 1994 - August 2005
Systemix 1993 - 1994
Skills
Regulatory Affairs, Design Control, ISO 13485, FDA, Medical Devices, CAPA, V&V, ISO 14971, Validation, Quality System, CE marking, PMA, Biotechnology, Biomedical Engineering, Quality Control, GMP, Clinical Trials, Catheters, Quality Assurance
Education
Oregon State University 1972 — 1978
Bachelor of Science (B.S.), Microbiology/Food Science & Technology
University of Alaska Fairbanks
Grifols Diagnostics (formerly Novartis Diagnostics) April 2015 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] May 2012 - Present
Medtronic Vascular June 2011 - April 2012
Medtronic Vascular October 2008 - June 2011
Medtronic Vascular October 2008 - September 2009
Medtronic Vascular February 2006 - September 2008
Baxter Healthcare June 2005 - August 2005
Skills
PMA, Medical Devices, FDA, 510 K, Regulatory Affairs, CE marking, CAPA, Design Control, QSR, ISO 13485, Quality Systems, Regulatory Strategy, Biomedical Engineering, IDE, Stents, Clinical Trials, Product Development, Auditing, Product Launch, Process Improvement, Medical Device Product..., Root Cause Analysis, Technical Writing, SOP, Sop, Quality System, Regulatory Submissions, Regulatory Requirements, Clinical Research, Strategy, Cross-functional Team...
Education
University of Southern California 2004 — 2006
Masters, Biomedical Engineering/Medical Devices and Diagnostic Engineering
Michigan Technological University 2000 — 2004
Bachelor of Science, Electrical Engineering
Sishya 1985 — 2000
High School, Sciences
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] January 2014 - Present
Abbott July 2013 - January 2014
Abbott February 2012 - August 2013
Abbott Laboratories April 2010 - February 2012
Abbott Laboratories June 2009 - April 2010
Abbott Labs January 2008 - May 2009
Guidant 1999 - 2007
Guidant January 1998 - January 2006
Skills
Design Control, ISO 13485, Medical Devices, FDA, CAPA, V&V, Validation, Quality System, Design of Experiments, ISO 14971, Root Cause Analysis, R&D, Biomedical Engineering, SPC, GMP, Six Sigma, Manufacturing..., Cross-functional Team..., Injection Molding, Lean Manufacturing, Design for Manufacturing, Catheters, Change Control, DMAIC, Process Engineering, Process Simulation, Supplier Quality, Quality Auditing, ISO, Commercialization, Quality Control, Manufacturing, 21 CFR Part 11, FDA GMP, FMEA, Technology Transfer, Product Development, Minitab, CQE, Computer System..., Continuous Improvement, Quality Assurance, Quality Management, Manufacturing Operations, 21 CFR, CQA, Engineering, 5S
Education
University of Redlands 2005 — 2007
MA, Management
Indiana University-Purdue University at Indianapolis 1994 — 1998
BS, Mechanical Engineering Technology
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] May 2012 - Present
Quinnipiac University August 2010 - May 2012
Life Technologies June 2011 - August 2011
Abbott Vascular August 2005 - July 2010
Skills
Sterilization, Laboratory, GMP, Aseptic Technique, Software Documentation, Quality Control, Lifesciences, Quality Assurance, Microbiology, PCR, LIMS
Education
Quinnipiac University 2010 — 2012
Masters in Health Sciences, Medical Laboratory Sciences
University of California, Riverside 2000 — 2004
B.S., Biology
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] March 2015 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] January 2014 - February 2015
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] May 2012 - December 2013
Abbott Vascular January 2011 - April 2012
Abbott Vascular May 2009 - December 2010
Skills
Design Control, ISO 13485, Catheters, ISO 14971, Medical Devices, Risk Management, Test Method Validation, Risk Assessment, CAPA, Product Transfer, Biocompatibility, Validation, Quality Assurance, Test Methodologies, FDA, Quality System, V&V, Root Cause Analysis, Six Sigma
Education
University of Southern California 2006 — 2009
Master of Science, Biomedical Engineering
University of California, Berkeley 2001 — 2005
Bachelors of Science, Bioengineering
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] October 2013 - Present
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] June 2012 - October 2013
Abbott Laboratories January 2012 - June 2012
Abbott Nutrition July 2011 - December 2011
Abbott Diabetes Care January 2011 - June 2011
Abbott Laboratories July 2010 - December 2010
Abbott Laboratories May 2009 - August 2009
Johns Hopkins University May 2008 - August 2008
Skills
Critical Chain Project..., Highly Adaptable, Teamwork, Supervising, International Business..., Process Validation, Complaint Management, Lean Initiatives, Staff Training, Management Presentations, Technical Writing, Engineering, Lean Manufacturing, V&V, Project Management, Quality Assurance, Validation, Project Planning, Continuous Improvement, ISO 13485, CAPA, Cross-functional Team..., FDA, Quality System, Medical Devices, Manufacturing
Education
Howard University 2006 — 2010
B.S., Chemical Engineering
ISO 13485
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] July 2013 - Present
Abbott Vascular January 2011 - June 2013
Abbott Vascular November 2009 - January 2011
Abbott Vascular June 2009 - November 2009
Abbott Vascular July 2008 - June 2009
Abbott Vascular July 2006 - July 2008
Education
California Polytechnic State University-San Luis Obispo 2001 — 2006
BS, MS, Bio Medical Engineering