Edwards Lifesciences
Industry: Medical device company
DescriptionEdwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring. It is mostly known for a transcatheter aortic heart valve made of bovine tissue within a collapsible stainless-steel stent, deployed via catheter. CEO: Michael A Mussallem (3 Apr 2000–) Headquarters: Irvine, California, United States Revenue: 3.4 billion USD (2017) Subsidiaries: Edwards Lifesciences LLC,
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Edwards Lifesciences Employees
Edwards Lifesciences January 2015 - Present
Baxter Healthcare December 2012 - December 2014
Baxter Healthcare May 2012 - December 2012
University of Southern California June 2011 - May 2012
University of Southern California August 2009 - May 2011
University of Southern California September 2009 - December 2010
University of Southern California August 2008 - December 2010
Skills
Matlab, Labview, NI LabVIEW, Solid Edge, Solidworks, Simulink, Calibration, cGMP manufacturing, Data Analysis, Technical Writing, JDE Enterprise One, Biomedical Engineering, Blue Mountain..., Technical Analysis, Sop, Change Control, cGMP practices, Trackwise, Teamcenter, Engineering, MS Project, Microsoft Word, Microsoft Excel, Microsoft Office, Visio, Project Planning, SolidWorks, SOP, LabVIEW
Education
University of Southern California 2011 — 2012
M.S, Biomedical Engineering
University of Southern California 2007 — 2011
B.S, Biomedical (Mechanical) Engineering
RCM Technologies July 2012 - Present
Edwards Lifesciences March 2011 - July 2012
Cordis, LLC August 2004 - October 2010
Skills
Quality Assurance, Quality Auditing, Quality Systems, Supplier Quality, Remediation, FDA, Validation, Assessment Strategies, Assessment Skills, Risk Assessment, Documentation, Training Skills, Medical Devices, Microsoft Office, JD Edwards, GMP, Lean Manufacturing, cGMP, Kaizen, SOP, 5S, ISO 13485, CAPA, ISO standards, QSR, Stents, Catheters, ISO 14001, 6S, Quality System, Lean manufacturing
Education
University of Puerto Rico-Aguadilla 1998 — 2004
Bachelor of Science (B.S.), Environmental Engineering Technology/Environmental Technology
L-3 Communications May 2015 - Present
Edwards Lifesciences April 1994 - March 2015
Edwards Lifesciences 1994 - 2010
Skills
Master Scheduling, Demand Planning, Order Fulfillment, Lean Manufacturing, Materials Management, Production Planning, MRP, Project Planning, Leadership, Warehousing, Supply Chain Management, Cross-functional Team..., Supply Chain, Continuous Improvement, Manufacturing, Supply Management, Kaizen, ISO, ERP, Value Stream Mapping, Quality System, Process Improvement, Logistics, Root Cause Analysis, DMAIC, Strategic Sourcing, Six Sigma, ISO 13485
Education
University of Phoenix 2003 — 2009
MBA, Business Administration, 4.0
Edwards Lifesciences August 2015 - Present
Edwards Lifesciences August 2015 - Present
Amgen January 2014 - July 2015
Education
University of Puerto Rico-Mayaguez
Bachelor's degree, Electrical Engineering
SpaceX May 2015 - Present
Edwards Lifesciences 2014 - 2015
Boston Scientific May 2013 - October 2013
Skills
Data Analysis, Microsoft Excel, International Relations, Mandarin, Leadership, Research, Microsoft Office, Social Networking, Public Speaking, Negotiation, SPSS, Analysis, Operations Management, Process Improvement, Economic Modeling, International Trade, JD Edwards, SAP ERP, Management, Supply Chain, Event Planning
Education
University of Southern California 2015 — 2016
Master of Science (M.S.), Global Supply Chain Management
University of Southern California 2010 — 2014
Bachelor of Arts (B.A.), Economics, International Relations Global Business
Wayzata High School 2006 — 2010
Amphenol July 2015 - Present
Edwards Lifesciences December 2013 - June 2015
St. Jude Medical May 2013 - October 2013
Bacardi 2011 - 2012
Ricardo Ortiz & Associates September 2006 - September 2010
Skills
Automation, CAPA, Minitab, Quality Management, Quality System, Root Cause Analysis, Validación, Lean manufacturing, Ingeniería, Análisis de causa raíz, Seis Sigma, Acciones correctivas y..., Análisis modal de..., Sistema de gestión de..., Manufactura
Education
polythecnic university of puerto rico 2011 — 2013
master of manufacturing Engineering, Manufacturing Engineering
University of Puerto Rico-Mayaguez 2001 — 2006
Bachelor of Applied Science (B.A.Sc.), Electrical and Electronics Engineering
Glenn International
Instalador y diseñador de sist. fotovoltaicos por AEE
Edwards Lifescience June 2013 - Present
Edwards Lifesciences May 2004 - June 2013
Johnson & Johnson August 2005 - March 2007
Baxter International Inc. May 2004 - June 2005
Skills
ISO 14971, Biomedical Engineering, Test Automation, Catheters, GMP, Quality Control, Manufacturing, R&D, Labview, Supplier Quality, Calibration, CE marking, Quality Auditing, Injection Molding, 21 CFR, FDA GMP, Change Control, Computer System..., Sop, 21 CFR Part 11, Manufacturing..., Gage R&R, Quality Management, Design for Manufacturing, Process Simulation, Technology Transfer, Automation, ISO, Process Capability, CQE, Iso 9000
Education
University of Phoenix 2007 — 2009
Master of Business Administration (MBA), Technology Transfer
University of Puerto Rico-Mayaguez 2000 — 2003
Bachelor's degree, Chemical Engineering
Validation Engineer September 2013 - March 2015
Bausch + Lomb April 2012 - October 2013
St. Jude Medical February 2011 - April 2012
Edwards Lifesciences April 2008 - March 2011
St. Jude Medical January 2002 - April 2008
Skills
FDA, Medical Devices, Six Sigma, Validation, Lean Manufacturing, Design Control, GMP, Quality System, Manufacturing, Product Development, Root Cause Analysis, Design for Manufacturing, Lean Six Sigma, V&V, DMAIC, Catheters, FMEA, Design of Experiments, R&D, Cross-functional Team..., SPC, Quality Assurance, Minitab, Continuous Improvement, Product Design, Quality Management, Biomedical Engineering, Manufacturing..., CAPA, Process Simulation, Process Improvement, Solidworks, Software Documentation, Engineering, Automation, Quality Control, 21CFR7, 21CFR803, 21CFR806, 21CFR820, ISO13485, ISO14001, ISO14971.
Education
University of Southern California 1989 — 1993
BS, Insdustrial and Systems Engineering (ISE)
Edwards Lifesciences July 2014 - Present
Edwards Lifesciences December 2012 - Present
Edwards Lifesciences 2007 - December 2012
Cordis 2005 - 2007
Hewlett-Packard 2000 - 2005
Skills
FMEA, DMAIC, Six Sigma, Root Cause Analysis, Testing, Medical Devices, Minitab, Quality System, Quality Assurance, Design of Experiments, Lean Manufacturing, CAPA, Internal Audit, Quality System..., FDA, Process Improvement, Quality Control, Continuous Improvement, ISO 13485, CQE, 21 CFR Part 11, 21 CFR, FDA GMP, Catheters, Manufacturing, CE marking, Engineering, Iso 9000, Complaint Management, Quality Auditing, GMP, Quality Management, Cross-functional Team..., Kaizen, ISO, ISO 14971, Green Belt, Product Development, V&V
Education
University of Puerto Rico-Mayaguez
Bachelor of Science (BS), Mechanical Engineering
University of Phoenix
Master of Business Administration (MBA), Technology Management
Edwards Lifesciences July 2013 - Present
Mycology Investigation January 2013 - May 2013
University of Puerto Rico 2009 - May 2013
Youth Innovative Solutions, Inc. October 2012 - December 2012
UPR Mayagüez Calidad de Vida June 2008 - June 2008
Zoo of Mayagüez Puerto Rico June 2007 - July 2007
Skills
Spanish, English, Interpersonal Skill, microbiology laboratory, chemical laboratory, Microscopy, Leadership, work under pressure, High Organizational..., Hood, Detailed Organization, Adult CPR, First Aid, Minitab, Clinical Microbiology, Parasitology, Virology, Professional..., Microbiology, Science, Microsoft Office, Microsoft Word, Research, Teamwork
Education
University of Puerto Rico-Mayaguez 2007 — 2013
Bachelor’s Degree, Biology, General
University of Puerto Rico-Mayaguez 2007 — 2013
Bachelor’s Degree, Industrial Microbiology
Robson's Farm LLC. January 2013 - Present
Johnson's Farm April 2012 - September 2012
Eli Lilly and Company June 2011 - April 2012
Edwards Lifesciences June 2010 - June 2011
Medquest Associates, Palmetto Imagaing May 2009 - June 2010
Pfizer, Capsugel Division June 2008 - August 2008
Skills
New Business Development
Education
University of South Carolina-Columbia 2005 — 2009
BA, Journalism and Mass Communications
Propper International, Inc November 2013 - Present
Edwards Lifesciences October 2011 - November 2013
Cordis, Johnson and Johnson March 2005 - October 2011
Skills
Industrial Engineering, New Product..., Lean Six Sigma, Fully bilingual English, Computer Proficiency, Supervisory Skills, Engineering Management, Manufacturing..., Continuous Improvement, Lean manufacturing, CAPA, Six Sigma, Root Cause Analysis, DMAIC, GMP, Manufacturing
Education
University of Puerto Rico-Mayaguez 1985 — 1989
Bachelor's Degree, Industrial Engineering, Bachelor
University of Puerto Rico-Mayaguez 1985 — 1989
Bachelor in Science, Industrial Engineering
Edwards Lifesciences August 2011 - Present
QSR Champs February 2011 - April 2011
Skills
Medical Devices, ISO 13485, FDA, Quality System, Lean Manufacturing, GMP, CAPA, Microsoft Office, Customer Service, Microsoft Excel, Microsoft Word, Public Speaking, Leadership, Teamwork, Research, Training, Human Resources, Quality Control, Manufacturing, Manufacturing Drawings, Digitalization, Clerical Skills, Clerical Work, Calibration, OSHA
Education
University of Puerto Rico - Aguadilla 2005 — 2012
Bachelor of Business Administration (BBA), Human Resources Management and Services
University of Puerto Rico-Aguadilla 2006 — 2008
Bachelor studies (60 credits) Quality Control, Quality Control and Safety Technologies/Technicians
First Team Real Estate September 2014 - Present
Edwards Lifesciences September 2006 - April 2014
Hewlett-Packard March 1999 - July 2006
TDK September 1980 - March 1999
Skills
Microsoft Office, Public Speaking, Process Improvement, Team Building, Microsoft Excel, Microsoft Word, Leadership, Training, Cross-functional Team..., Six Sigma, Quality System, Operations Management, Design Control, ISO 13485, FDA, Medical Devices, Manufacturing, Validation, DMAIC, Lean Manufacturing
Education
University of Phoenix 2003 — 2005
Bachelor's Degree, Business Management
Kevane Grant Thornton March 2014 - Present
Edwards Lifesciences September 2014 - December 2014
Rock Solid Technologies, Inc. May 2014 - August 2014
Skills
Teamwork, Accounting, Customer Service, Financial Accounting, Auditing, Microsoft Office, Financial Analysis, Income Tax, Tax, Financial Statements, Internal Controls, Microsoft Dynamics ERP, Microsoft Dynamics GP, Account Reconciliation, Spanish
Education
University of Puerto Rico-Mayaguez 2011 — 2016
Bachelor of Science in Business Administration (In progress), Accounting and Business/Management
Southwestern Educational Society 1997 — 2011
High School Diploma
Zimmer July 2014 - Present
Edwards Lifesciences May 2009 - July 2014
Edwards Lifesciences May 2008 - May 2009
Edwards Lifesciences April 2007 - May 2008
GE February 2007 - March 2007
GE August 2005 - February 2007
Stryker June 2004 - August 2005
Skills
Demand Planning, ISO 13485, Lean Manufacturing, MRP, Materials Management, Medical Devices, Supply Chain, Supply Chain Management, Supply Management, Kanban, Strategic Sourcing, Supplier Development, Supply Chain..., Six Sigma, Cross-functional Team..., Continuous Improvement, Manufacturing
Education
University of Puerto Rico-Mayaguez 1998 — 2004
Bachelor's degree, Industrial Engineering
Edwards Lifesciences January 2015 - May 2015
UPRM Complexity Metrics for Automated Processes, Dr. Lourdes Medina January 2013 - May 2014
Skills
Creative Problem Solving, Microsoft Excel, Group Work, SketchUp, Minitab, Arena Simulation..., Access, Microsoft Office
Education
University of Puerto Rico-Mayaguez
Bachelor of Science (B.S.), Industrial Engineering
Edwards Lifesciences November 2013 - Present
Edwards Lifesciences May 2012 - November 2013
WyzAnt Tutoring April 2012 - April 2013
Ikona Medical Corporation May 2010 - August 2010
USC Biomedical Imaging Laboratory September 2009 - December 2009
San Marino Academy June 2006 - August 2007
Skills
Biomedical Engineering, Microsoft Excel, NI LabVIEW, Medical Imaging, Image Processing, PowerPoint, Matlab, Labview, Testing, Software validation, Statistics, Medical Devices, Public Speaking
Education
University of Southern California 2007 — 2011
B.S., Biomedical Engineering
San Marino High School 2004 — 2007
Edwards Lifesciences July 2015 - Present
Edwards Lifesciences March 2014 - July 2015
Orange County Register June 2005 - February 2014
Skills
Accounts Receivable, Accounting, Training Manuals, Procedure Manuals, Leadership, Social Media, Training, Time Management, Process Improvement, Project Management, Team Leadership, Project Planning, Business Analysis, Vendor Management, Program Management, Cross-functional Team..., Business Process..., Quality Assurance, Customer Service, Business Process, ERP, Troubleshooting, Finance, Analysis
Education
University of Phoenix-Southern California Campus 2010 — 2012
Bachelor of Science (B.S.), Information Technology Concentration in Information Systems Security, 3.85/4.0
University of Phoenix-Southern California Campus 2008 — 2010
Associate of Arts (AA), Accounting, 3.83
New Horizon Computer Learning Center
Ranging from technical skills to ITIL methodology courses
Edwards Lifesciences May 2003 - December 2012
LifeScan 2001 - 2003
Baxter Bentley - Cardiovascular Group 1993 - 2000
Skills
ISO 13485, Design Control, CAPA, Medical Devices, FDA, Quality System, Validation, V&V, Design of Experiments, DMAIC, FMEA, Six Sigma, Minitab, SPC, Lean Manufacturing, Root Cause Analysis, Continuous Improvement, GMP, Manufacturing, ISO, Supplier Quality, R&D
Education
University of Puerto Rico-Mayaguez
Amgen January 2013 - Present
Edwards Lifesciences May 2012 - Present
Amgen November 2006 - May 2012
UnitedHealthcare June 2006 - November 2006
Skills
CDISC, Clinical Trials, SAS, Oracle Clinical, Clinical Data Management, EDC, FDA, CRO, Validation, Clinical Development, Biotechnology, SDTM, Oncology, Regulatory Submissions, Pharmaceutical Industry
Education
University of Southern California 2003 — 2006
MS, Biostatistics
University of Southern California 1999 — 2006
Doctor of Philosophy (Ph.D.), Linguistics
Edwards Lifesciences August 2015 - Present
Gilead Sciences November 2014 - August 2015
CCL Industries April 2013 - November 2014
Actavis, Inc. (Formerly Watson Pharmaceuticals, Inc.) August 2008 - April 2013
Actavis, Inc. (Formerly Watson Pharmaceuticals, Inc.) June 2005 - August 2008
Actavis February 2003 - June 2005
Triple Check Investigations December 1999 - February 2003
Skills
21 CFR Part 11, CAPA, FDA, Change Control, GxP, GMP, Sop, Validation, V&V, Computer System..., GAMP, Regulatory Requirements, ISO 13485, Pharmaceutical Industry, Quality Assurance, Quality System, LIMS, Trackwise, Cross-functional Team..., Cleaning Validation, Aseptic Processing, GLP, Regulatory Affairs, SOP, Quality Auditing, Biotechnology, Pharmaceutics, Manufacturing, Management, Technology Transfer
Education
University of Phoenix 1995 — 1997
Bachelor of Arts (BA), Management
American Society for Quality, 2007 — 2007
ASQ-CQIA, Cerified Quality Improvement Associate
California State University-Fullerton 2003 — 2005
Pharmaceutical Engineering
University of Southern California 1996 — 1998
Entrepreneur Business Management
AMA, American Management Association 2012 — 2012
Certificate in Business Communications
Edwards Lifesciences January 2015 - Present
Edwards Lifesciences July 2013 - January 2015
University of Southern California August 2012 - May 2013
GE Healthcare June 2012 - August 2012
University of Southern California August 2008 - May 2012
Stanford University June 2010 - August 2010
Santa Clara University June 2009 - August 2009
Skills
Matlab, Labview, C++, Microsoft Office, Word, Excel, Research, Statistics, Programming, Engineering, SDS-PAGE, Data Analysis, Signal Processing, Mathematica, Pspice, Biomedical Engineering, Medical Devices, Microsoft Word, Microsoft Excel, Image Processing, Molecular Biology, ImageJ, HPLC, Cell Culture
Education
University of Southern California 2012 — 2013
Master of Science (M.S.), Biomedical Engineering (Medical Devices and Business)
University of Southern California 2008 — 2012
Bachelors in Science, Biomedical Engineering
Milpitas High School 2004 — 2008
High School Diploma
Edwards Lifesciences August 2012 - Present
Edwards Lifesciences January 2012 - August 2012
USC UTRC September 2007 - August 2012
Corning Inc January 2006 - August 2006
Skills
Heart valve stent and..., Catheter-based..., Proficient in..., Experienced in the..., Simulation softwares..., Spin-coating,..., Sensors, Biomedical Engineering, R&D, Testing, Labview, Engineering, Experimentation, Matlab, Materials Science
Education
University of Southern California 2006 — 2012
PhD, Materials Science
National Tsing Hua University 2001 — 2003
Master's degree, Materials Science
Banco Popular de Puerto Rico June 2014 - Present
Edwards lifesciences December 2011 - October 2013
Eurest May 2011 - December 2011
Skills
Microsoft Office, Microsoft Excel, Customer Service, Marketing Strategy, Strategic Planning, Teamwork, Microsoft Word, PowerPoint, English, Team Building
Education
University of Puerto Rico-Mayaguez
Citi August 2013 - Present
Citi October 2010 - August 2013
Edwards Lifesciences January 2010 - October 2010
SERVICIOS INTEGRADOS DE REHABILITACION DEL OESTE, INC (SIRO) 2006 - 2007
Hospital Metropolitano Cabo Rojo Psychiatric Hospital 2005 - 2006
Department of Education of Puerto Rico 2004 - 2005
Skills
Computer Hardware, Computer Maintenance, Computer Repair, Networking, CCNA, Cisco Technologies, Bilingual, Spanish, Troubleshooting, LAN-WAN, Microsoft Technologies, Windows, Leadership, Network Administration, TCP/IP, VoIP, Network Design, BGP, Cisco IOS, System Administration, Switches, Routers, WAN, Cisco Routers, Active Directory, Windows Server, Technical Support, Operating Systems, Software Installation, Help Desk Support, OSPF, Routing, EIGRP, IT Operations, XP, Windows 7, IP, Cisco Certified, DHCP, Juniper, Frame Relay, IPSec, Routing Protocols, Computer Network..., Ethernet, Firewalls, Network Security, Network Engineering, VPN, Data Center
Education
Inter-American University of Puerto Rico-Aguadilla Campus 2008 — 2010
B.S. in Computer Science in Installing and Repairing Computer Systems and Networking, Computer Systems Networking and Telecommunications, 3.95
University of Puerto Rico-Mayaguez 1996 — 2004
Bachelor of Arts (BA), Physical Education Teaching and Coaching, 3.4
Chronic Communications November 2011 - Present
USC Marshall Alumni Association, Orange County Chapter July 2014 - Present
DeviceAlliance March 2011 - January 2013
Edwards Lifesciences 2009 - 2011
FischerHealth 2002 - 2009
Weber Shandwick 1999 - 2002
Smith Public Relations 1992 - 1998
Earlier Relevant Experience 1987 - 1992
Skills
Media Relations, Reputation Management, Marketing Communications, Product Development, Employee Engagement, Change Management, Corporate Communications, Crisis Communications, Strategic Communications, Public Relations, Internal Communications, Integrated Marketing, Marketing Strategy, Social Media, Press Releases
Education
University of Southern California
Bachelor of Arts (BA), Communications Arts and Sciences
Hewlett-Packard May 2012 - Present
Edwards Lifesciences August 2011 - December 2011
Tabacalera Hoja Boricua January 2011 - May 2011
University of Puerto Rico January 2011 - May 2011
University of Puerto Rico, Graduate Studies Office August 2009 - December 2009
University of Puerto Rico, General Chemistry Building January 2009 - May 2009
Ferreteria Comercial Crespo January 2004 - January 2006
Skills
Microsoft Office, Excel, Word, PowerPoint, Access, SAP, SFNG, Lean Manufacturing, Fluent English, Fluent Spanish, AutoCAD, Minitab, Spanish, English, VBA, SketchUp, CAD, Visio
Education
University of Puerto Rico-Mayaguez 2005 — 2011
Industrial Engineering, Industrial Engineering
Wapa Televisión December 2013 - Present
Edwards Lifesciences May 2013 - July 2013
Volunteer Income Tax Assistance February 2013 - April 2013
University of Puerto Rico, Mayaguez Campus- Library August 2007 - May 2010
Skills
Accounts Payable, Fixed Assets, Peachtree, Microsoft Office, Income Tax, JD Edwards, Bilingual-English/Spanis..., Deposits, Bank Reconciliation, Cash Receipts, Logs Reconciliation, CODA Financials
Education
University of Puerto Rico-Mayaguez
Bachelor of Business Administration (BBA), Accounting/Human Resources
Edwards Lifesciences February 2015 - Present
OCRA- Orange County RegulatoryAffairs DG October 2014 - Present
Bausch + Lomb June 2012 - February 2015
Skills
Regulatory Affairs, Medical Devices, Clinical Research, Clinical Trials, Clinical Pharmacology, Pharmaceutical Industry, Pharmacology, Pharmacovigilance, Pharmacokinetics, Pharmaceutics, Pharmacists, Organic Chemistry, Medicinal Chemistry, Analytical Chemistry, Event Management, Event Planning, Quality Auditing, Quality Management, Quality Assurance, Microsoft Excel, Microsoft Office, Microsoft Word, Marketing Research, Lifesciences, HPLC, GMP, FDA, GLP, Regulatory Submissions, PMA, CAPA, ISO 13485, ISO 14971, GCP, Life Sciences
Education
University of Southern California 2011 — 2013
Masters in Regulatory Science, Clinical trials, Drug and Devices Regulations, Bio-med Commerce, Quality Assurance, 3.5
University of Pune 2007 — 2012
Bachelor Of Pharmacy, Pharmaceutics, Pharmacology, Pharmacognosy(Natural Product Chamistry), Medicinal Chemistry, Q.A, Q.C, 3.5
Edwards Lifesciences September 2015 - Present
CardiAQ Valve Technologies July 2014 - August 2015
CardiAQ Valve Technologies August 2013 - July 2014
Medtronic June 2009 - August 2013
Medtronic March 2009 - June 2009
Medtronic May 2008 - August 2008
Medtronic May 2007 - August 2007
Skills
Solidworks, Minitab, R&D, Labview, Six Sigma, Cross-functional Team..., Design Control, ISO 13485, Design of Experiments, Matlab, Solid Edge, C, Microsoft Office, Green Belt, ERP, Black Belt, SAP, ISO 5840-3, SolidWorks, Medical Devices, Manufacturing, Biomedical Engineering, Lean Manufacturing
Education
University of Southern California 2012 — 2015
Master of Science (M.S.), Biomedical Engineering
University of Southern California 2005 — 2009
Bachelor of Science (B.S.), Biomedical Engineering
Econo April 2014 - Present
Edwards Lifesciences September 2013 - November 2013
Soto Master Engineering, Inc. October 2011 - January 2012
Western Fire Equipment, Inc. January 2009 - January 2011
University of Puerto Rico August 2008 - December 2008
Puerto Rico Fire Department June 2007 - July 2007
Puerto Rico Department of Education June 2004 - July 2004
Skills
Human Resources, Accounting, Microsoft Excel, Financial Accounting, Financial Analysis, Financial Reporting, Financial Statements, Microsoft Office, Microsoft Word, PowerPoint, Bilingual Proficiency, Interpersonal Skill, Tutoring, Peachtree, Auditing, Internal Controls, Analysis, Public Speaking, Research
Education
Interamerican University of Puerto Rico, Aguadilla Campus 2014 — 2016
Master of Business Administration (M.B.A.), Accounting
University of Puerto Rico-Aguadilla 2012 — 2013
Bachelor of Business Administration (BBA), Accounting, Management & Finance, 3.90
University of Puerto Rico-Arecibo 2007 — 2011
Bachelor of Business Administration (BBA), Accounting and Finance, 3.80
Janssen, Pharmaceutical Companies of Johnson and Johnson February 2014 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson February 2012 - January 2014
Edwards Lifesciences August 2010 - December 2010
Skills
Minitab, Kaizen, Value Stream Mapping, Kanban, Lean Tools, Certified Lean Six..., Certified in Lean..., A3 Thinking, 6S, Bilingual, SMED, Standard Work, Microsoft Excel, Design of Experiments, Leadership, AutoCAD, Visio, Layout, Google Sketchup, Ergonomics, Human Error Reduction, Pull System, Protocol, DMAIC, Lean Manufacturing, Manufacturing, 5S, Industrial Engineering, CAPA, Cross-functional Team...
Education
University of Puerto Rico-Mayaguez 2005 — 2012
Bachelor's degree, Industrial Engineering
Southwestern Educational Society 1996 — 2005
High School
DePuy Synthes Spine, a Johnson & Johnson Company June 2012 - Present
DePuy Spine, a Johnson & Johnson company January 2010 - June 2012
Cardiovascular Research Foundation 2007 - 2009
Cordis Corporation, a Johnson & Johnson company 1996 - 2007
Edwards Lifesciences 1985 - 1996
Kurzweil Applied Intelligence, Inc. January 1991 - December 1991
Education
University of Pittsburgh
BS, Business
Edwards Lifesciences March 2015 - Present
Edwards Lifesciences March 2013 - March 2015
Wake Forest University School of Medicine July 2003 - February 2013
North Carolina BioNetwork March 2008 - January 2012
Wake Forest University School of Medicine September 1999 - July 2003
Wake Forest University School of Medicine January 1995 - September 1999
Skills
Clinical Research, Clinical Trials, Research, Medical Devices, Research Ethics, CTMS, GCP, Regulatory Submissions, Project Coordination, Data Analysis, Leadership, Training, FDA, Pediatric Research
Education
Wake Forest University 2011 — 2013
Bachelor of Science (B.S.), Clinical, Population, and Translational Research
University of Phoenix 2002 — 2004
MBA, Healthcare Management
Wake Forest University 1991 — 1994
BS, Biology and Psychology
Edwards Lifesciences April 2000 - Present
Access Closure March 2008 - April 2009
Futuretech Inc. 1997 - May 2000
DePuy Orthopaedics 1995 - 1997
DePuy Orthopaedics 1992 - 1995
Skills
Vascular, Medical Devices, Orthopedic, Hospitals, Product Launch, Neurology, Surgeons, Cardiology, Radiology, Cath Lab, Market Development, Interventional..., Interventional Radiology, General Surgery, Surgical Instruments, Operating Room, Sales Operations, Sports Medicine, Capital Equipment, Disposables, Surgery, Healthcare
Education
University of Richmond 1988 — 1992
Bachelor of Arts (B.A.), Economics
St. Martin's High School 1975 — 1988
Endologix Inc January 2015 - Present
Endologix Inc July 2013 - Present
Endologix Inc July 2012 - July 2013
Edwards Lifesciences September 2011 - May 2012
Abbott Medical Optics August 2011 - May 2012
Replenish, Inc May 2011 - May 2012
Caldera Medical June 2010 - August 2010
Center for Applied Rehabilitation Technology - Rancho Los Amigos National Rehabilitation Center February 2010 - May 2010
Caldera Medical June 2009 - August 2009
Skills
Product Development, Medical Devices, R&D, Surgeons, FDA, Lean Manufacturing
Education
Keck Graduate Institute 2010 — 2012
M.B.S., Medical Device and Business of Bioscience
University of Southern California 2007 — 2010
B.S., Biomedical Engineering
Edwards Lifesciences July 2014 - Present
UPR-Mayaguez Chemical Engineering Department August 2013 - May 2014
Edwards Lifesciences January 2014 - March 2014
UPR- Mayaguez Chemical Department January 2011 - May 2013
Skills
Bioengineering, Biotechnology, Microbiology, Chemistry Laboratory..., Leadership, Pharmaceutical Industry, Biofuels
Education
University of Puerto Rico-Mayaguez 2009 — 2014
Bachelor of Science (BS), Industrial Microbiology
General Mills August 2014 - Present
General Mills June 2013 - August 2014
Eaton Corporation April 2012 - June 2013
Amgen July 2011 - December 2011
Edwards Lifesciences August 2010 - December 2010
Skills
Lean Manufacturing, Process Improvement, Six Sigma, Minitab, TPM, Business Process..., Microsoft Excel, AutoCAD, SAP, SPC, Production Layout, Lean Fundamentals, Leadership Development, Team Management, Food Safety, Value Stream Mapping, DMAIC, Certified Green Belt, Visio, SketchUp, Lean Champion, Lingo, Arena Simulation..., Management Engineering, Contract Pricing, Organizational..., HACCP, Volunteering
Education
Polytechnic University of Puerto Rico 2012 — 2015
Master's Degree, Engineering Management
University of Puerto Rico-Mayaguez
Bachelor of Science (BS), Industrial Engineering
Edwards Lifesciences November 2013 - Present
Edwards Lifesciences May 2010 - November 2013
Medtronic April 2010 - May 2010
Medtronic February 2006 - March 2010
Education
University of Phoenix Online 2005 — 2009
Bachelor of Science, Business/Communications
University of Phoenix Online
Certification in Project Management
Medtronic April 2014 - Present
Abbott June 2013 - August 2013
Associated Students of Biomedical Engineering June 2010 - May 2013
Edwards Lifesciences June 2012 - December 2012
Bayer HealthCare June 2011 - August 2011
Bayer HealthCare June 2010 - August 2011
Skills
Matlab, Solidworks, Solid Edge, Pro Engineer, Microsoft Office, Conversational Spanish, Fermentation, 5S, Six Sigma, Manufacturing, Validation, Engineering, R&D, Medical Devices, Biomedical Engineering, LabVIEW, Data Analysis, Microsoft Excel
Education
University of Southern California 2012 — 2014
Master of Science (M.S.), Medical Device & Diagnostics Engineering
University of Southern California 2009 — 2013
Bachelor of Science, Biomedical Engineering (Mechanical Emphasis)
Los Gatos High School
OptumHealth Specialty Benefits September 2010 - November 2013
Liberty Dental Plan September 2008 - June 2010
SafeGuard Dental & Vision 2003 - 2008
Health Net Dental & Vision Irvine CA January 2002 - November 2003
Pacificare Dental & Vision, Santa Ana CA January 1994 - January 2002
Edwards Lifesciences 1992 - 1994
Edwards Lifesciences 1986 - 1988
TRW Space and Defense 1975 - 1986
Skills
Project Management, Cross-functional Team..., Product Management, Health Insurance, New Business Development, Management, Strategy, Leadership, Program Management, Process Improvement, Account Management, Business Process..., Analysis, Six Sigma
Education
University of Phoenix 1982 — 1984
BSBA, Business Administration
United States Air Force May 2015 - Present
United States Air Force May 2014 - February 2015
Zimmer December 2013 - May 2014
Sports Authority September 2013 - November 2013
US Air Force Reserve January 2013 - June 2013
Edwards Lifesciences January 2013 - May 2013
Skills
Minitab, Lean Manufacturing, Microsoft Excel, Six Sigma, Microsoft Office, Industrial Engineering, MS Project, Matlab, AutoCAD, PowerPoint, Solidworks, Leadership, VBA, Yellow Belt, SketchUp, Microsoft Word, Engineering, Arena Simulation..., Quality Assurance, Quality Control, Project Management, Microsoft PowerPoint, SolidWorks
Education
Universidad Del Este 2013 — 2014
Master of Business Administration (MBA), Project Management
University of Puerto Rico-Mayaguez 2006 — 2013
Bachelor of Science (BS), Industrial Engineering
Edwards Lifesciences February 2015 - Present
n/a-freelance January 2015 - Present
Honeywell Aerospace January 2012 - December 2014
Celestica June 2006 - December 2006
Skills
Electrical Engineering, Research, System Automation, Testing, NI LabVIEW, Microsoft Office, Microsoft Operating..., Mac OS, Solaris, Test Automation, Data Analysis, Electronic..., Electrical Design, Laboratory Equipment, Acoustics, Analog Circuits, GPIB, Control Systems Design, Piezoelectric, Class-D amp, Magnetics, Magnetic Nanoparticles, Process Control, PCB Design, Coils Design, NI Multisim, Ultiboard, PSpice, LogicWorks, Matlab, MathCAD, COMSOL, Visual Basic, TestStand, Sound Design, Music Production, Film Production, Premiere, Adobe Audition, FL Studio, Garageband, Kontakt
Education
University of Puerto Rico-Mayaguez 2012 — 2013
Certificate, Cinematography and Film/Video Production
University of Puerto Rico-Mayaguez 2008 — 2011
Master of Science (M.S.), Electrical Engineering
University of Puerto Rico-Mayaguez 2002 — 2008
Bachelor of Science (B.S.), Electrical Engineering
Ascenda Medical Marketing July 2014 - Present
Consultant June 2008 - Present
Teleflex Medical May 2005 - September 2007
Edwards Lifesciences July 2002 - May 2005
TherOx October 1998 - July 2002
CardioThoracic Systems 1996 - 1998
SimulTrans 1994 - 1996
Skills
Start-up Consulting, Start-up Support, Cardiovascular Devices, Orthopedic devices, Product Lifecycle..., Product Marketing, Medical Devices, Clinical Marketing, Market Research, Marketing Communications, Corporate Identity, Product Naming, New Business Development, Sales Cycle Analysis, Sales Cycle Modeling, Sales Projections, Product Launch, Global Documentation..., Product Requirements..., Presentation Material, Global Marketing, Product Training, Marketing, Competitive Analysis, Product Management, Hospitals, Product Requirements, Forecasting, Marketing Strategy, Web Marketing Strategy, Cardiology, Vascular, Interventional..., Sales Process..., Cardiac Surgery, Leadership, Surgical Instruments, Training, Strategic Planning, Market Planning, Business Planning, Grant writing, Grant Writing
Education
University of San Diego
Bachelor of Arts (B.A.)
Honeywell Aerospace June 2014 - Present
Honeywell Aerospace December 2013 - June 2014
GE August 2013 - December 2013
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2013 - July 2013
Edwards Lifesciences January 2012 - May 2012
Thrifty Car Rental (Div of NRMA) July 2008 - July 2008
Municipality of Aguada June 2008 - June 2008
Consortium of Aguada June 2007 - July 2007
Skills
Lean Manufacturing, Kaizen, Value Stream Mapping, Minitab, Continuous Improvement, Visio, GMP, Time Study, Teamwork, Leadership, Time Management, Microsoft Excel, Arena Simulation..., VBA, SAP, Communication Skills, Highly responsible, Learning Quickly, Spanish-English, Microsoft Word, PowerPoint, Outlook, AutoCAD, SketchUp, Change Management, LPS, Ergonomics
Education
University of Puerto Rico-Mayaguez 2008 — 2014
Bachelor's Degree, Industrial Engineering
Edwards Lifesciences Technology Sarl May 2011 - Present
Edwards Lifesciences May 2006 - Present
Skills
Medical Devices, Manufacturing, ISO 13485, Design Control, Design of Experiments, FDA, Validation, CAPA, Minitab, Quality System, V&V, DMAIC, Catheters
Education
University of Puerto Rico-Mayaguez 1973 — 1979
Engineer's Degree, Mechanical Engineering, Bachelor in Sciences
Edwards Lifesciences Sr. Financial AnalystEdwards Lifesciences2006 - 2009
ATK 2004 - 2006
Education
University of Phoenix
Master of Business Administration (MBA)
Edwards Lifesciences September 2014 - Present
Johnson & Johnson February 2014 - September 2014
Baxter Healthcare January 2013 - January 2014
Gilead Sciences April 2012 - December 2012
CareFusion October 2011 - April 2012
CIBA Vision March 2011 - October 2011
Philips June 2010 - March 2011
Zimmer 2010 - 2011
Zimmer 2010 - 2011
Mendez & Co January 2010 - June 2010
Skills
FDA, 21 CFR Part 11, GMP, Computer System..., Validations, SOP, Change Control, Quality Assurance, Medical Devices, Validation, Compliance, Manufacturing, Documentation, ERP, Auditing, SAP, Automation, Change Management, Process Validation, ISO, CAPA, FMEA, Process Improvement, LIMS, Strategic Planning, SDLC, Inventory Management, Document Management, Quality Systems, Continuous Improvement, GxP, JD Edwards, SOX, Visio, cGMP, Integration, Testing, Spanish, Requirements Analysis, Biotechnology, Business Analysis, Materials Management, MES, GAMP, Software Validation, Software Documentation, Project Management, MS Project, Microsoft Office, Microsoft Visio
Education
University of Puerto Rico-Mayaguez 1985 — 1989
BA, Business Administration
University of Puerto Rico-Mayaguez 1976 — 1980
Associate of Arts and Sciences (AAS), Computer Science
Edwards Lifesciences September 2014 - Present
Coldwell Banker March 2013 - Present
Brigham Young university July 2011 - April 2012
David C Clark and Associates April 2011 - August 2011
Liberty Homes April 2011 - August 2011
Richmond American Homes 2010 - 2011
Rainey Homes June 2008 - October 2008
Wright Homes November 2006 - November 2007
Ashton Woods Homes May 2001 - October 2006
Skills
Customer Service, New Home Sales, Contract Negotiation, Budgets, Accounting, Construction, Sales
Education
University of Phoenix 2008 — 2010
BS Business Management, Accounting
Accounting Services May 2011 - Present
Resources Global Professionals 2009 - 2011
Bear Stearns April 2007 - October 2008
Resources Global Professionals May 2003 - April 2007
Edwards Lifesciences 2001 - 2002
Accounting Services 2000 - 2001
West Capital Financial Services January 1999 - May 2000
General Atomics Aeronautical Systems 1997 - 1998
Vista Hill Healthcare 1986 - 1993
Skills
Leadership, Finance, Budgets, Forecasting, Financial Reporting, Payroll, Process Improvement, Cash Management, Auditing, Project Planning, Financial Modeling, Financial Analysis, Business Process..., Management, Banking, Accounts Payable, Managerial Finance, Accounting, Strategic Financial..., Strategic Planning, Healthcare, Analysis, Project Management, Accounts Receivable, Financial Statements, Management Consulting
Education
University of San Diego 1993 — 1997
Bachelor of Accountancy
Shoji LLC June 2011 - Present
Edwards Lifesciences February 1974 - June 2011
Education
Western State University College of Law 1978 — 1982
JD, Law
University of Southern California 1969 — 1978
BSIE, MSIE, MBA, Industrial & Systems Engineering, Business Administration
First American Financial Corporation November 2010 - Present
International Rectifier November 2009 - December 2010
Tatum 2008 - 2008
Computer Sciences Corporation 2008 - 2008
Master-Halco, Inc. 2006 - 2007
Edwards Lifesciences 2004 - 2006
Ropak Corporation 1995 - 2002
Deloitte and Touche 1988 - 1994
Education
University of Southern California
MBT, Tax
University of Southern California
BS, Accounting
Edwards Lifesciences January 2013 - Present
Edwards Lifesciences January 2010 - January 2013
Edwards Lifesciences April 2007 - January 2010
University of Southern California August 2008 - May 2009
Waste Management of San Diego/Orange County June 2005 - April 2007
University of Southern California May 2004 - May 2005
Weber Shandwick January 2001 - May 2004
PRSA-LA, Board of Directors 2001 - 2004
Skills
Press Releases, Strategic Communications, Public Relations, Media Relations, Corporate Communications, Internal Communications, Marketing Communications, Newsletters, Event Planning, Strategy, Publications, Crisis Communications, Public Speaking, Social Media, Leadership, Community Outreach, Strategic Planning, Speech Writing
Education
University of Southern California 1997 — 2000
Edwards Lifesciences July 2015 - Present
Education
University of Southern California 2015 — 2019
Bachelor's degree, Biochemistry
Katella High School 2011 — 2015
High School Diploma, High School/Secondary Diplomas and Certificates
Edwards Lifesciences April 2015 - Present
Skills
Medical Devices, Manufacturing, FMEA, Design of Experiments, Engineering, Quality System, Lean Manufacturing, Engineering Management, FDA, Cross-functional Team..., DMAIC, CAPA, Manufacturing..., Six Sigma, ISO, Validation, ISO 13485, R, Root Cause Analysis, Quality Assurance, SolidWorks, Continuous Improvement
Education
University of Puerto Rico-Mayaguez 1980 — 1984
Bachelor of Science (BS), Mechanical Engineering
U.S. Army Engineer Research and Development Center (ERDC) June 2015 - August 2015
College of Engineering - UPRM August 2014 - May 2015
Edwards Lifesciences August 2013 - December 2013
IEEE-CSS UPRM May 2013 - December 2013
UPRM June 2011 - December 2013
US Department of Transportation (DOT) June 2013 - August 2013
IEEE-CSS UPRM April 2012 - May 2013
Skills
Matlab, Solidworks, Mechanical Engineering, Engineering, Pro Engineer, Microsoft Office, Microsoft Excel, Finite Element Analysis, Teamwork, Electronic Engineering, Mathematica, PowerPoint, Microsoft Word, Inventor, Customer Service, Code of Federal..., Rulemaking, DOT regulations, Outlook, Research, System Dynamics, Materials Science, Manufacturing Processes, Minitab
Education
University of Puerto Rico-Mayaguez 2014 — 2016
Master’s Degree, Master of Engineering (M Eng.) Mechanical Engineering-Machine Sciences Program, GPA 3.50/4.00
University of Puerto Rico-Mayaguez 2008 — 2013
Bachelor’s Degree, Bachelor of Sciences (BS) Mechanical Engineering
Dr. Pedro Perea Fajardo Vocational 2005 — 2008
GED and Vocational Diploma, Accounting and Finance
Hewlett-Packard April 2011 - Present
Honeywell Aerospace July 2008 - April 2011
Bristol-Myers Squibb January 2003 - January 2007
Edwards Lifesciences January 2002 - January 2003
Skills
Contract Management, Strategic Sourcing, Supply Management, Supply Chain, Forecasting, Aerospace, Pharmaceutical Industry, Customer Support, Bilingual-English/Spanis..., SAP R/3, SAP BW, Windows, Process Excellence, Cost Control, Data Analysis, Commodity Pricing, Multi Tasking, Vendor Management, Supply Chain..., Supplier Negotiation, Government Contracting, Purchasing Processes, Leadership, Strategic Planning, Green Belt, Team-oriented, Cross-functional Team..., Customer Service, Order Fulfillment, Lean Manufacturing, Lean Management, Six Sigma, Procurement, Continuous Improvement, Engineering Management
Education
University of Puerto Rico-Mayaguez 1996 — 2006
Master of Business Administration (MBA), Engineering/Industrial Management, Cum Laude
Dufry April 2014 - Present
Edwards Lifesciences January 2013 - May 2013
Zoom Media Group July 2011 - July 2012
Skills
Journal Entries, JD Edwards, Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Teamwork, English, Leadership, Public Speaking, Research, Analysis
Education
University of Puerto Rico-Mayaguez 2008 — 2013
Bachelor of Business Administration (B.B.A.), Finance, General
Colegio San Ignacio de Loyola
High school diploma
Edwards Lifesciences 2009 - Present
Edwards Lifesciences April 2005 - January 2009
Edwards Lifesciences April 2002 - April 2005
Edwards Lifesciences January 1999 - April 2002
Baxter International Inc. August 1996 - January 1999
Baxter International Inc. June 1995 - August 1996
Baxter International Inc. May 1994 - June 1995
Advanced Interventional Systems May 1992 - May 1994
Sorin Biomedical January 1992 - May 1992
Baxter International Inc. January 1990 - January 1992
Skills
Biotechnology, Capital Equipment, Cardiology, Cross-functional Team..., Disposables, FDA, Healthcare, Hospitals, Market Development, Medical Devices, Neurology, Operating Room, Orthopedic, Pharmaceutical Industry, Pharmaceutical Sales, Product Development, Product Launch, Product Marketing, Sales Effectiveness, Sales Operations, Selling, Strategic Planning, Surgeons, Surgery, Urology, Orthopedics, Sales
Education
University of Phoenix
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
Edwards Lifesciences August 2014 - April 2015
Skills
UGS NX5, Microsoft Office, Bilingual-English/Spanis..., Mechanical Engineering, CNC manufacturing, ANSYS, Thermodynamics, CAD, Minitab, Matlab, Solidworks, AutoCAD, Pro Engineer, Lean Manufacturing, Engineering, Unigraphics, Fluid Mechanics, Manufacturing, PTC Creo
Education
University of Puerto Rico-Mayaguez 2007 — 2014
Bachelor's degree, Mechanical Engineering
Edwards Lifesciences April 2015 - Present
Edwards Lifesciences March 2013 - April 2015
Edwards Lifesciences October 2009 - March 2013
Viterbi Academic Resource Center August 2006 - May 2009
Hansen Medical June 2008 - August 2008
Abbott Vascular Devices May 2007 - August 2007
Algas-SDI 2006 - 2006
Skills
Solidworks, Matlab, AutoCAD, Catheters, Solid Edge, Mechanical Engineering, Labview, Minitab, Biomedical Engineering, Pro Engineer, Finite Element Analysis, Six Sigma, Product Development, Smarty, Medical Devices, Manufacturing, Positive Team Player, Rapid Prototyping, Design of Experiments, R, Mechanical Testing, Engineering, Medical Device R, Biomechanics, DMAIC, Product Design, Abaqus
Education
University of Southern California 2004 — 2009
BS and MS, Mechanical Engineering
Thermo Fisher Scientific January 2014 - Present
Life Technologies July 2010 - Present
Edwards Lifesciences 2008 - 2010
Memorex/Imation 2004 - 2008
Kia Motors America 1997 - 2004
Kia Motors America 1994 - 1997
Education
University of Santo Tomas
BA, Economics
Endologix Inc April 2015 - Present
Edwards Lifesciences November 2013 - April 2015
Edwards Lifesciences July 2011 - November 2013
Edwards Lifesciences January 2011 - May 2011
Alcon Laboratories, Inc. January 2010 - September 2010
Center for Vision Science and Technology August 2008 - May 2009
Beckman Coulter May 2006 - August 2008
Skills
Medical Devices, Six Sigma, Lean Manufacturing, FDA, V&V, Continuous Improvement, Process Improvement, Manufacturing, ISO 13485
Education
University of Southern California 2009 — 2011
Master's Degree, M.S. Biomedical Engineering - Medical Devices and Diagnostics Engineering
University of Southern California 2005 — 2009
Bachelor's Degree, B.S. Biomedical Engineering
Apple July 2015 - Present
Edwards Lifesciences December 2011 - July 2015
Edwards Lifesciences May 2011 - January 2012
sanofi-aventis June 2005 - June 2011
Biovail Pharmaceuticals, Inc November 2004 - May 2005
Enterprise Rent-A-Car June 2002 - November 2004
Education
University of Southern California - Marshall School of Business 2007 — 2010
Masters, Business Administration
University of Southern California 1998 — 2002
BS, Business
Edwards Lifesciences September 2014 - Present
Bio Tilitiy at the University of Florida December 2013 - September 2014
AxoGen April 2013 - June 2014
Exactech March 2010 - April 2013
CardioQuest 2006 - 2010
Skills
Medical Devices, FDA, Orthopedic, Biotechnology, Regulatory Affairs, Clinical Research, Cross-functional Team..., Cardiology, Sop, Biologics, Lifesciences, Clinical Study Design, Neurology, Trial Management, R&D, Clinical Trials, Protocol, Biomaterials, Biomedical Engineering, V&V, Operating Room, CE marking, Validation, Software Documentation, Life Sciences
Education
University of South Florida 2005 — 2009
BS, Biomedical Sciences
Productos La Aguadillana March 2012 - Present
Edwards Lifesciences June 2015 - July 2015
Education
University of Puerto Rico-Mayaguez 2013 — 2017
Bachelor’s Degree, Marketing
Visa May 2014 - Present
Goldman Sachs April 2011 - May 2014
Edwards Lifesciences September 2010 - February 2011
Bumble Bee Foods September 2009 - December 2009
McNeil Consumer Healthcare January 2009 - July 2009
GE Energy May 2008 - August 2008
Skills
Analysis, Process Improvement, VBA, Matlab, Leadership, Teamwork, Engineering, Minitab, Equity Derivatives, Spanish-speaking, Margin, Strategic Planning, Risk Management, Financial Regulation, Technical Writing, Asking Questions, Settlement, Project Management, Spanish, Microsoft Excel, Learning Quickly, Microsoft Office
Education
University of Puerto Rico-Mayaguez 2005 — 2010
Bachelor of Science (BS), Industrial Engineering, 3.87/4.0
Endologix Inc November 2012 - Present
Edwards Lifesciences November 2011 - November 2012
Medtronic CardioVascular September 2010 - October 2011
Medtronic CardioVascular October 2008 - September 2010
Medtronic CardioVascular September 2005 - September 2008
Alfred Mann institute, University of Southern California January 2002 - September 2005
Skills
Medical Devices, Regulatory Affairs, Clinical Research, FDA, Clinical Trials, CTMS, GCP, Cardiology, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, Clinical Study Design, ISO 13485, Biomedical Engineering, Design Control, CAPA, Validation, Biotechnology, Quality System, R&D
Education
University of Southern California
MS, Electrical Engineering
University of Southern California
MS, Biomedical Engineering- Medical Device Diagnostic Engg.
Sonendo®, Inc. October 2013 - June 2014
OC private company August 2013 - October 2013
OC med. device co. May 2012 - May 2013
Lifescience public company in OC. September 2011 - May 2012
American Vanguard Inc February 2009 - July 2011
Corinthian Colleges March 2008 - September 2008
Edwards Lifesciences June 2002 - April 2008
Litton Industries 1998 - 2002
Aspen Communications plc July 1995 - August 1998
Deloitte. August 1989 - June 1993
Skills
Enterprise Risk..., Internal Audit, Fraud Investigations, Audit, Auditing, Risk, Governance, Inventory Management, Audit Committee, Cost Accounting, Internal Controls, Compliance, Risk Assessment, Corporate Governance, Due Diligence, Risk Management, Accounting, Financial Analysis, Financial Accounting, Manufacturing, GAAP, Financial Control, Risk Mitigation, QAD, Financial Risk, Fraud, Strategy, Finance, IT Audit, SEC filings, US GAAP, Leadership, Management, Sarbanes-Oxley, Sarbanes-Oxley Act
Education
The University of Reading 1986 — 1989
BSc (Hons), Chemistry and Food Science
Bexleyheath School 1979 — 1986
Edwards Lifesciences April 2014 - Present
Edwards Lifesciences June 2011 - April 2014
Hexcel Corporation September 2007 - June 2011
Schiff Nutrition International September 2005 - September 2007
Schiff Nutrition International January 2000 - September 2005
Schiff Nutrition International January 1998 - January 2000
Schiff Nutrition International November 1997 - January 1998
Waxie Sanitary Supply October 1993 - November 1997
Skills
MRP, ERP, Project Management, T-SQL, Business Process..., Continuous Improvement, Lean Manufacturing, Inventory Management, JD Edwards, Process Improvement, Supply Chain Management, Supply Chain, Analysis, Business Process, Microsoft SQL Server, Cross-functional Team..., Manufacturing, Business Analysis, Logistics, Training, Software Documentation, Leadership, Business Intelligence, Quality Assurance, Six Sigma
Education
University of Phoenix
Bachelors of Science, Information Technology
Edwards Lifesciences August 2006 - Present
Skills
FDA, Regulatory Affairs, ISO 13485, Regulatory Submissions, PMA, Medical Devices, CAPA, Design Control, GMP, Validation, Regulatory Requirements, Clinical Trials, Sop, Quality System, CE marking, ISO 14971, SOP
Education
University of Phoenix 2002 — 2005
Business Management
Edwards Lifesciences February 1997 - Present
Education
University of Southern California
Finance
Edwards Lifesciences April 2012 - Present
Covidien October 2010 - April 2012
ev3 October 2008 - October 2010
ev3 October 2006 - October 2008
Skills
Design Control, ISO 13485, ISO 14971, CAPA, FDA, Medical Devices, Minitab, Design of Experiments, Biomedical Engineering, Quality System, FMEA, SPC, Validation, GMP, R&D, Root Cause Analysis, Quality Assurance, Supplier Quality, Quality Control, DMAIC, Lean Manufacturing, Six Sigma, Design for Manufacturing, Cross-functional Team..., Manufacturing
Education
University of Southern California 2002 — 2006
BS, Biomedical Engineering
Edwards Lifesciences December 2014 - Present
Medtronic November 2011 - December 2014
Medtronic CoreValve September 2009 - November 2011
Medtronic CardioVascular June 2008 - September 2009
Medtronic CardioVascular May 2006 - June 2008
Medtronic Vascular December 2002 - August 2005
Education
University of Southern California 2006 — 2009
MS, Biomedical Engineering
University of Southern California 2002 — 2006
BS, Biomedical Engineering
IHP Development, Inc. April 2006 - Present
Edwards Lifesciences 2006 - 2012
CB Richard Ellis 2009 - 2010
Amcor Sunclipse 2004 - 2005
Profit Concepts International 1997 - 2005
Skills
Software Development, ERP, Microsoft SQL Server, Business Process, JD Edwards, EDI, Integration, Business Intelligence, Databases, Financials
Education
University of Southern California 1993 — 1997
BS, Computer Engineering/Computer Science
Edwards Lifesciences December 2014 - Present
Edwards Lifesciences October 2013 - Present
Edwards Lifesciences November 2012 - October 2013
Edwards Lifesciences October 2011 - November 2012
Edwards Lifesciences July 2010 - October 2011
Edwards Lifesciences January 2009 - July 2010
Edwards Lifesciences July 2007 - December 2008
Advanced Bionics May 2006 - August 2006
Skills
Heart Valves, Medical Devices, Product Launch, Market Development, Commercialization, Cardiology, Interventional..., Biomedical Engineering, Product Marketing, Cross-functional Team..., Product Management, Global Marketing
Education
University of Southern California 2003 — 2007
B.S., Biomedical-Biochemical Engineering
R J Pryce LLC August 2015 - Present
Edwards Lifesciences November 2010 - July 2015
DePuy (Johnson & Johnson) January 2009 - November 2010
Johnson & Johnson November 2008 - January 2010
Johnson & Johnson March 2007 - November 2008
Cordis 2004 - 2007
Ortho Clinical Diagnostics 2001 - 2004
Ortho Clinical Diagnostics 2001 - 2004
Ortho Clinical Diagnostics 1998 - 2000
Skills
Six Sigma, Medical Devices, Design Control, Lean Manufacturing, Operational Excellence, FDA, Quality System, DMAIC, Validation, Quality Auditing, Black Belt, Process Excellence, Manufacturing, Cross-functional Team..., CAPA, Quality Management, Process Improvement, Program Management, Design of Experiments, ISO 13485, Supply Chain, Minitab, GMP, SPC, Value Stream Mapping, Root Cause Analysis, Kaizen, Continuous Improvement, FMEA, 5S, Green Belt, Kanban, Toyota Production System, V, ISO, V&V
Education
The University of Glamorgan 1987 — 1990
MI BIOL, CBIOL, Biochemistry
Ysgol Gyfun Rhydfelen 1977 — 1983
Edwards Lifesciences October 1976 - May 2014
Skills
ISO 13485, Cross-functional Team..., Biomedical Engineering, FDA, Medical Devices, Design Control, CAPA, V&V, Design of Experiments, Lean Manufacturing, Validation, Quality System, Six Sigma, Product Development
Education
University of Southern California
MS, Biomedical Engineering
University of Wisconsin-Madison
BS, Mechanical Engineering
Edwards Lifesciences Sr. Director, Human ResourcesEdwards Lifesciences2007 - Present
Ceridian March 1998 - August 2007
Education
University of San Francisco
Johnson & Johnson August 2011 - Present
Edwards Lifesciences March 2005 - August 2011
Johnson & Johnson , Baxter Healthcare, Schering Plough, Wyeth 1990 - 2005
Skills
ISO 13485, Medical Devices, Design Control, CAPA, FDA, ISO 14971, V&V, Quality System, Validation, GMP, 21 CFR, CE marking, PMA, 21 CFR Part 11, Biomedical Engineering, Design of Experiments, FMEA, Minitab, Quality Assurance, FDA GMP
Education
Phoenix University - Puerto Rico Branch 1990 — 1994
MBA, MT(ASCP) and Business Adm.
University of Phoenix 1990 — 1994
MBA, Business Administration, Management and Operations
Edwards Lifesciences December 2010 - Present
Pre-Paid Legal Services, Inc. July 2007 - Present
Masimo Corporation August 2006 - December 2010
Medtronic 2000 - 2006
Education
University of Southern California 1993 — 1997
Edwards Lifesciences February 2012 - Present
Edwards Lifesciences March 2008 - January 2012
Edwards Lifesciences March 1997 - March 2008
Baxter Healthcare December 1989 - March 1997
U.S. Army August 1984 - February 1993
Baxter Healthcare May 1988 - December 1989
Skills
Product Development, Medical Devices, Marketing Strategy, Budget Management, Strategic Planning, Product Management, Cross-functional Team..., Product Marketing, Life Sciences, Market Research, Competitive Analysis, Strategy Development, Business Strategy, Lifesciences, FDA, ISO 13485, Validation, R&D, Quality Assurance, Design Control, Product Launch, Regulatory Affairs, Commercialization, Budgets, CAPA, Capital Equipment, Market Development, Strategy, Biomedical Engineering, Design of Experiments, Quality System, V&V, Vascular, Leadership
Education
University of Phoenix 2003 — 2008
BSB/M, MBA/Mkt, Business Management and Marketing
Siemens Healthcare June 2005 - Present
Siemens Medical Solutions USA, Inc. June 2005 - January 2010
Triage Medical 2001 - 2002
Radiance Medical Systems (now Endologix) 2000 - 2001
Edwards Lifesciences October 1999 - August 2000
Nobel Biocare (Formerly Steri-Oss) June 1992 - October 1999
Skills
FDA, Medical Devices, Quality System, Clinical Trials, ISO 13485, Design Control, CAPA, Regulatory Affairs, Biotechnology, Validation, GMP, Clinical Research, Quality Management, Quality Assurance
Education
University of Scranton 1985 — 1989
B.S., International Studies/Business
Edwards Lifesciences April 2014 - Present
Edwards Lifesciences March 2014 - April 2014
Edwards Lifesciences April 2012 - March 2014
Phenomenex January 2009 - April 2012
Phenomenex January 2008 - January 2009
Phenomenex October 2005 - January 2008
Skills
Biotechnology, Pharmaceutical Industry, Lifesciences, Medical Devices, Product Management, Marketing Strategy, Product Marketing, Business Development, Market Research, Cross-functional Team..., Marketing Management
Education
Concordia University Irvine 2012 — 2014
Master of Business Administration (MBA), Business Administration and Management, General
University of San Diego 2003 — 2005
BA, Biology
Integra LifeSciences November 2014 - Present
Edwards Lifesciences May 2014 - November 2014
Medtronic November 2013 - April 2014
Skills
Medical Devices, FDA, CAPA, GMP, Quality System, ISO 13485, 21 CFR Part 11, Customer Service, Microsoft Office, Leadership
Education
University of Puerto Rico-Mayaguez 1996 — 2003
Bachelor's Degree, Industrial Engineering
Edwards Lifesciences January 2012 - June 2015
Edwards Lifesciences March 2009 - January 2012
Johnson & Johnson 2002 - 2009
Hanes 1999 - 2002
B.Braun July 1994 - November 1999
Skills
Supply Chain, Demand Planning, Supply Chain Management, Supply Management, Cross-functional Team..., Change Management, Logistics, Inventory Management, Continuous Improvement, MRP, Purchasing, Six Sigma, Lean Manufacturing, Materials Management, Strategic Sourcing, Supply Chain...
Education
University of Puerto Rico-Mayaguez 1990 — 1992
Master of Business Administration (M.B.A.), Industrial Management, Finance
University of Puerto Rico-Mayaguez 1985 — 1990
Bachelor's Degree, Industrial management
Colegio del Pilar
CSL Behring October 2014 - Present
Edwards Lifesciences November 2013 - September 2014
1199 SEIU February 2012 - October 2013
Citi May 2011 - February 2012
Macsteel Service Centers USA October 2010 - May 2011
Qualcomm January 2010 - September 2010
University of Southern California September 2008 - May 2010
Kaushal Industries July 2007 - July 2008
Skills
QlikView, OBIEE, SQL, Data Warehousing, Data Mining, Requirements Gathering, Analytics, Requirements Analysis, Team Management, Training & Development, Microsoft Office, Microstrategy, Excel, MS Project, Visio, SharePoint, Oracle SQL, SQL Server, Microsoft SQL Server, PL/SQL, Business Objects, Software Documentation, Agile Methodologies, Business Process..., Data Analysis, Business Analysis
Education
University of Southern California 2008 — 2010
Master of Science (MS), Industrial and Systems Engineering
Visvesvaraya Technological University 2003 — 2007
Bachelor of Engineering, Mechanical Engineering
Fluor Corporation February 2014 - Present
United States Navy Reserves January 2000 - Present
Edwards Lifesciences July 2013 - September 2013
Precision Systems Engineering June 2005 - December 2008
Diafuku America February 2005 - June 2005
Companion Systems Engineering August 2004 - January 2005
American Hintech February 2004 - July 2004
Metalline Fabrication January 2003 - January 2004
Skills
Team Leadership, Project Management, AutoCAD, Customer Service, Military, Program Management, Manufacturing, Intelligence, Engineering, Troubleshooting, DoD, Analysis, Microsoft Office, Technical Writing, Microsoft Excel, CAD, Management
Education
University of Phoenix 2009 — 2010
MS/AJS, Law
ITT Technical Institute 2003 — 2004
Industrial Design, Computers and design
ITT Technical Institute 2000 — 2002
AAS Computer Aided Drafting and Design, Computers and design
Edwards Lifesciences December 2012 - Present
St. Jude Medical March 2012 - December 2012
Integra LifeSciences April 2010 - March 2012
Chest Innovations May 2009 - August 2009
USC Keck School of Medicine Image Processing and Informatics Lab April 2008 - May 2009
Applied Materials & Engineering Inc. June 2007 - September 2007
Skills
Microsoft Project, Risk Management, ISO 13485, Minitab, Solidworks, AutoCAD, PDP, Oracle Database, IQ/OQ/PQ, Validation, FMEA, FMCEA, Product Development, R&D, ASTM, Compliane, Quality Systems, BSBME, BSEE, MSEE, GD&T, 21 CFR 860, ISO 14971, Analog mixed-signal,..., SQL, VHDL, C, Matlab, Labview, PSICE, Root Cause Analysis, CAPA, Quality System
Education
University of Southern California 2009 — 2012
MS, Electrical Engineering
University of Southern California 2005 — 2009
BS, Biomedical Engineering
Edwards Lifesciences Critical Care Division January 1990 - July 2010
Edwards Lifesciences 1990 - 2010
Edwards Lifesciences September 1984 - January 1990
American Edwards Laboratories July 1981 - September 1984
Skills
Operating Room, Medical Devices, Cardiac Surgery, Market Development, Capital Equipment, Disposables, Vascular, Surgeons
Education
University of Pittsburgh 1972 — 1976
Bachelor of Arts (B.A.), Social Sciences
Edwards Lifesciences February 2014 - Present
Working from Home February 2003 - February 2014
Edwards Lifesciences June 1995 - February 2003
Mattel February 1995 - June 1995
Jet Propulsion Laboratory September 1993 - February 1995
Nissan Motor Co., Ltd. August 1988 - July 1993
Mattel April 1986 - August 1988
Skills
Problem Solving, JD Edwards, Requirements Analysis, Software Project..., Systems Analysis, Data Conversion, Communication Skills, System Testing, Defining Requirements, Software Conversions, Upgrades, Issue Management, Data Reconciliation, Interfaces, Mentoring, Cultural Awareness, Employee Training, Cross-functional..., Business Intelligence, PeopleSoft, ERP, Software Documentation, Project Management, Business Analysis, Process Improvement, Visio, Cross-functional Team...
Education
University of Pittsburgh 1981 — 1985
BS, Information Science & Computer Science
Edwards Lifesciences
Skills
Continuous Improvement, Medical Devices, DMAIC, FDA, ISO 13485, Quality System, Design Control, ISO 14971, Change Control, ISO, Lean Manufacturing, 21 CFR Part 11, Quality Auditing, Root Cause Analysis, CAPA, Design of Experiments, V&V, Minitab, Sop, SPC, 21 CFR, FMEA, Supplier Quality
Education
University of Puerto Rico-Mayaguez
BSIE
University of Puerto Rico-Mayaguez
BSIE, Industrial Eng.
Edwards Lifesciences July 2011 - Present
CareFusion September 2007 - October 2010
Hudson RCI 1993 - 2005
Skills
FDA, Design Control, ISO 13485, Manufacturing, Lean Manufacturing, CAPA, Quality System, Six Sigma, Medical Devices
Education
University of Phoenix 2000 — 2004
BSBA, Business Administration
Herlocher Foods Inc June 2011 - Present
Overhead Door Corporation September 2005 - January 2009
Edwards Lifesciences February 1999 - November 2004
Edwards Lifesciences February 1988 - January 1999
Skills
Account Reconciliation, Accounts Payable, Inventory Management, Supply Chain, Purchasing, Analysis, MRP, Materials Management, Management, Budgeting
Education
University of Puerto Rico
B.S.B.A, Industrial Management and Accounting
University of Puerto Rico-Mayaguez
Bachelor of Science in Business Administration (BSBA), Industrial Management & Accounting
ZOLL Medical Corporation April 2013 - Present
Precision Therapeutics March 2010 - December 2012
Edwards Lifesciences January 2008 - January 2010
CR Bard January 2004 - January 2008
Johnson & Johnson January 1995 - January 2004
Johnson & Johnson 1995 - 2003
Skills
Medical Devices, Microsoft Office, Product Development, Microsoft Excel, Project Management, Strategic Planning, Sales Management, Customer Service, New Business Development, Marketing Strategy, Process Improvement, Microsoft Word, Healthcare, PowerPoint, Sales, Negotiation, Manufacturing, Team Building, Biotechnology, Oncology, Sales Operations, Hospitals, Operating Room
Education
University of Puerto Rico - Rio Piedras Campus
B.A, Business Administration
University of Puerto Rico-Rio Piedras
Bachelor of Business Administration (B.B.A.), Marketing
Medtronic July 2014 - Present
Edwards Lifesciences August 2010 - July 2014
Curesearch Children's Oncology Group 2008 - 2010
Bolton Medical 2008 - 2008
St. Jude Medical 2006 - 2008
St. Jude Medical 2004 - 2006
Skills
Medical Device Clinical..., Medical Device..., Cardiovascular Disease, Cardiovascular Imaging, Oncology Clinical..., Cardiac..., Endovascular, Cardiac Rhythm..., Sales, Literature Reviews, Design Control, Data Management, Clinical Research..., Cardiology, Clinical Trials, FDA
Education
University of Southern California 1998 — 2003
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Edwards Lifesciences February 2013 - Present
Edwards Lifesciences October 2012 - February 2013
City of Hope December 2011 - September 2012
City of Hope August 2008 - November 2011
United Health Group December 2005 - August 2008
Skills
Clinical Data Management, SAS programming, Statistics, Clinical Trials, EDC, Biostatistics, Healthcare, Survival Analysis, R, SAS, Epidemiology, Data Management, Programming, Analysis, Logistic Regression, CRO, Clinical Development, Data Analysis, Oncology, Clinical Research
Education
University of Southern California 2004 — 2005
MS, Biostatistics/Epidemiology
Peking University, China 1995 — 2000
BS, Public Health
C. R. Bard, Inc. June 2014 - Present
C. R. Bard, Inc. June 1998 - June 2014
C. R. Bard, Inc. July 1995 - May 1998
Edwards Lifesciences June 1992 - July 1995
Skills
Software Documentation, Medical Devices, CAPA, Manufacturing, ISO 13485, Manufacturing..., Root Cause Analysis, Root Cause Problem..., Labeling Controls, FDA, Quality System, V&V, Validation, Quality Auditing, DMAIC, Quality Control, Design Control, Lean Manufacturing, Continuous Improvement
Education
University of Puerto Rico - Mayaguez 1984 — 1992
BSIE, Engineering
University of Puerto Rico-Mayaguez
Bachelor of Science in Industrial Engineering
Stryker March 2013 - Present
Edwards Lifesciences August 2012 - December 2012
LifeScan August 2011 - December 2011
Skills
Microsoft Excel, Microsoft Office, Microsoft Word, Microsoft Publisher, Minitab, SketchUp, Arena Simulation..., Trackwise, AutoCAD, Visio, PowerPoint, Industrial Engineering, Validation
Education
University of Puerto Rico-Mayaguez 2006 — 2012
Bachelor of Science (B.S.), Industrial Engineering
Lisa Thon School of Fashion Design 2008 — 2010
Technical degree, Fashion Design
Wine Country Gift Baskets March 2006 - Present
Corning Incorporated 2000 - 2002
Edwards Lifesciences May 1989 - May 1999
Skills
Microsoft Office, Training, Inventory Management, Microsoft Excel
Education
University of Phoenix
Edwards Lifesciences March 2009 - April 2015
Baxter Healthcare February 1988 - April 2000
Education
University of Phoenix
Bachelor of Science (BS), Business Administration and Management, General
Edwards Lifesciences July 2012 - Present
Virco Mfg. December 2002 - June 2012
PTC 1997 - 2000
Skills
Product Design, CAD, Product Development, AutoCAD, Solidworks, Manufacturing, Design for Manufacturing, Pro Engineer, Industrial Design, Sheet Metal, Lean Manufacturing, GD&T, Engineering, Project Management, Solid Modeling
Education
USC 1994 — 1996
Bachelor's degree, Mechanical Engineering
Whitworth University 1991 — 1994
Bachelor of Arts (B.A.), Physics
Edwards Lifesciences October 2012 - Present
Medtronic CoreValve January 2010 - October 2012
Medtronic Heart Valve October 2006 - January 2010
Baxter Healthcare January 2000 - October 2006
Skills
ISO 13485, V&V, Medical Devices, Design Control, FDA, Manufacturing..., Biomedical Engineering, Design for Manufacturing, Design of Experiments, FMEA, Manufacturing
Education
USC 2003 — 2006
Bachelor of Science (BS), Mechanical Engineering
Amgens Foundation September 2012 - October 2012
Edwards Lifesciences January 2012 - May 2012
Education
University of Puerto Rico-Mayaguez 2007 — 2013
Bachelor's degree, Microbiology, General
University of Puerto Rico-Mayaguez 2007 — 2013
Bachelor's degree, Biology, General
Edwards Lifesciences February 1997 - Present
Skills
Microsoft Office, Management, Microsoft Excel, Microsoft Word, PowerPoint, Leadership, Training
Education
University of Southern California
Bachelor of Science (BS), Accounting and Finance