HeartWare Inc
Industry: Company
DescriptionHeadquarters: Framingham, MA Parent organization: Medtronic, Inc. Subsidiaries: HeartWare Inc, HeartWare Ltd
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HeartWare Inc Employees
HeartWare Inc June 2014 - Present
Skills
GDP, Data Reconciliation, Metrics Reporting, Cross-functional..., Mail Merge, Field Action Process, Technical Writing, Visual Management..., Access, Maya, SOR 98-282, MEDDEV 2.12-1, 21 CFR Part 820, 21 CFR Part 806, Medical Devices
Education
Broward College 2012 — 2013
Associate of Arts (A.A.), General Studies
Nova Southeastern University 2011 — 2012
Biology/Biological Sciences, General
HeartWare Inc February 2012 - Present
Kewill August 1995 - October 2011
ASA International 1985 - 1994
Smith, Batchelder & Rugg, CPA 1983 - 1985
Skills
Editing, HTML, Online Help, Software Documentation, Technical Writing, Manuals, Newsletters, Web Content, Technical Documentation, Agile Methodologies, Technical Communication, CMS, Proofreading, CSS, Business Process, Software Project..., Databases
Education
Simmons College 1979 — 1980
MBA, Business
Boston University 1971 — 1973
BA, English Language & Literature
Boston University
Bachelor of Arts (BA), English
Simmons College
Master of Business Administration (MBA)
HeartWare Inc MCSD CoordinatorUniversity of Pennsylvania Health System2009 - 2012
University of Pennsylvania Health System 2005 - 2009
Skills
Medical Devices, Cardiac Surgery, Heart Failure, Clinical Research, Critical Care, Clinical Trials, Healthcare, Healthcare Management, ICU, Medicine, Nursing, Operating Room, Surgery, Patient Safety, Ventricular Assist...
Education
Drexel University
Bachelor of Science (BS), Nursing
La Salle University
Bachelor of Arts (BA), Biology
HeartWare Inc January 2014 - Present
HeartWare Inc January 2012 - December 2013
Concentric Medical/ Stryker Neurovascular March 2011 - January 2012
Medtronic Invatec Cardiovascular August 2008 - March 2011
Cordis March 2004 - January 2008
Cordis November 2000 - February 2004
Ortho-McNeil Pharmaceutical September 1996 - October 2000
Skills
Neurology, Product Launches, Vascular, Surgeons, Medical Devices, Product Launch, Cardiology, Clinical Trials, Operating Room, Surgery, Vascular Surgery, Capital Equipment, Disposables, Interventional..., Radiology, Sales Operations, Spine, Market Development
Education
DePaul University - Charles H. Kellstadt Graduate School of Business 1998 — 2000
MBA, Marketing
Kent State University 1990 — 1994
BS, Business Management
HeartWare Inc September 2014 - Present
Florida Department of Health October 2011 - June 2014
Florida Department of Health June 2006 - March 2012
D1 Master Paint January 2006 - May 2006
Georgia Department of Human Resources January 2003 - October 2005
Florida Department of Health January 2002 - December 2002
Skills
Epidemiology, Biostatistics, Data Analysis, Literature Reviews, Public Health, Statistics, SPSS, Infectious Diseases, Data Collection, Data Management, Statistical Data..., Geospatial Mapping, Microsoft Office Suite, Environmental Impact..., Analytical Reports, FDA Food Regulatory..., Food Safety, Office Administration, Certified Food Safety..., Research, Grant Writing, Analysis
Education
Florida Agricultural and Mechanical University 1999 — 2001
Master, Public Health
Florida Agricultural and Mechanical University 1995 — 1999
Bachelor of Science (BS), Psychology
Twin-Star International May 2014 - Present
HeartWare Inc July 2013 - May 2014
Alaris Aerospace Systems LLC February 2011 - July 2013
Skills
Financial Reporting, General Ledger, Internal Controls, Accruals, US GAAP, Revenue Recognition, Accounting, Auditing, Account Reconciliation, Journal Entries, Payroll, Outlook, Accounts Payable, Microsoft Word, Microsoft Excel, Forecasting, Microsoft Office
Education
Florida Atlantic University 2010 — 2013
Bachelor's degree, Accounting
Impola International Incorporated August 2015 - Present
Del Monte Fresh Produce N.A., Inc August 2014 - August 2015
Auxis December 2012 - August 2014
HeartWare Inc September 2012 - December 2012
ChemPoint August 2010 - May 2011
ChemPoint January 2010 - August 2010
ChemPoint October 2009 - January 2010
ChemPoint March 2009 - October 2009
Chempoint.com August 2008 - February 2009
Bryant Christie Inc. December 2007 - March 2008
Skills
Microsoft Office, Global Logistics, Data Analysis, Cultural Awareness, Languages, Procurement, Purchasing, Logistics, Resource Allocation, Strategic Consulting, Supply Chain Management, Supply Chain..., Word, Inventory Management, Excel, Teamwork, International Business, Supply Chain, Product Development, Contract Negotiation, Customer Service, Strategic Planning, Outlook, Customer Relations, Budgeting, Process Improvement, Business Strategy, PowerPoint, Spanish, Analysis, Forecasting, Problem Solving, Team Leadership, New Business Development, Team Building, Account Management, Start-ups, Competitive Analysis, Research, Program Management, Business Analysis, Product Management, Administration, Market Analysis, Planning, Product Marketing, Management Consulting, Leadership, Market Research, Project Management
Education
Trinity International University 2012 — 2015
Masters In Counseling/Psychology
Chile 2011 — 2011
Fluency in Spanish
Seattle Pacific University 2006 — 2008
B.A., Business Administration/International Business
Seattle Pacific University - School of Business and Economics 2006 — 2008
BA, International Business
Xi Nan Da Xue (Chongqing, China) 2007 — 2007
International Business
Everett Community College 2003 — 2005
AA, Arts and Sciences
Olympus IMS January 2014 - Present
HeartWare Inc 2012 - 2013
Sportservice Agganis Arena October 2009 - November 2012
Skills
Microsoft Excel, Matlab, Solidworks, Microsoft Office, Management, Customer Service, Teamwork, OS X, Windows, Engineering
Education
Boston University 2009 — 2013
Bachelor of Science (BS), Mechanical Engineering
HeartWare Inc August 2014 - Present
Sunshine Heart, Inc September 2011 - August 2014
Medtronic May 2008 - September 2011
Medtronic January 2005 - April 2008
Medtronic March 2003 - December 2004
Genzyme January 2000 - March 2003
Boston Scientific January 1992 - January 2000
Unilever January 1989 - January 1992
Procter & Gamble December 1984 - January 1989
Skills
Global Marketing, Marketing Strategy, Sales Management, Product Management, Market Development, Medical Devices, Competitive Analysis, Product Development, Strategy, Leadership, Management, Market Planning, Marketing, Marketing Management, P, Pricing, Product Launch, Sales, Product Marketing, Start-ups, Strategic Planning, Business Strategy, Cardiology, Commercialization, Cross-functional Team..., Healthcare, International Sales, Coaching
Education
Northeastern University - Graduate School of Business Administration 1997 — 1999
MBA, Business
University of Delaware 1980 — 1984
BSBA, Business Administration
HeartWare Inc. March 2014 - Present
HeartWare Inc April 2010 - March 2014
RAPS Annual Conference 2013 - 2013
Cordis Corporation 2001 - 2010
Duke University 1999 - 2000
Skills
Design Control, ISO 13485, ICH-GCP, Hospitals, FDA, Biotechnology, Medical Devices, Regulatory Affairs, CAPA, Quality System, Regulatory Submissions, V&V, ISO 14971, Validation, GMP, Change Control, 21 CFR, 21 CFR Part 11, Biomedical Engineering, FDA GMP, Medical Device Directive, CE marking, CQA, Regulatory Requirements
Education
Duke University 1996 — 2000
Miami Springs Senior High School
Applied MedTech LLC April 2014 - Present
Florida Arcade & Pinball Exposition March 2012 - Present
HeartWare Inc December 2007 - April 2014
Cordis 1997 - 2007
Boston Scientific (was Symbiosis) February 1994 - August 1996
US Navy August 1989 - August 1993
Skills
Medical Devices, ISO 13485, FDA, Biomedical Engineering, Troubleshooting, Validation, V&V, CAPA, Electronics, Catheters, Quality System, Design of Experiments, Technical Writing, Technical Documentation, Graphic Design, Website Development, CAD/CAM, Solidworks, AutoCAD, NEMA, FDA GMP, Machining, Minitab, Design Control, SolidWorks
Education
ATI Career Training Center-Miami 1994 — 1997
Associate's degree, Electrical and Electronics Engineering
The Johns Hopkins University Applied Physics Laboratory May 2015 - Present
BlackBerry August 2014 - May 2015
Avionica inc February 2014 - June 2014
Research January 2012 - December 2013
Demetech March 2013 - June 2013
HeartWare Inc May 2012 - August 2012
Skills
Microcontrollers, Labview, Embedded Systems, Solidworks, Matlab, Multisim, C++, Medical Devices, AutoCAD, Mastercam, Microfluidics, GMP, Testing, Troubleshooting, Embedded Linux, Data Acquisition, Embedded Software, Digital Electronics, Analog Circuit Design, HFSS Designer, Altium Designer, Data Analysis, Circuit Design, RF Design, Microelectronics, PCB Design, C, Java, Digital Signal..., Communication Systems, Wireless Communications..., Serial Communications, PLC
Education
Florida International University 2014 — 2015
Master's Degree, Electrical Engineering, 3.93
Florida International University 2010 — 2013
Bachelor's Degree, Computer Engineer, 3.3
HeartWare Inc November 2014 - Present
Stryker May 2013 - November 2014
Biomet 3i August 2011 - May 2013
University of Miami September 2006 - May 2010
Skills
Biomedical Engineering, FDA, R&D, Validation, Manufacturing, Design Control, Medical Devices, Design of Experiments, V&V, Quality System, Inventor, Pro Engineer, Biomaterials, Machining, FMEA, Product Development, Engineering, Lean Manufacturing, Minitab, SolidWorks, Cross-functional Team..., Root Cause Analysis, Mechanical Engineering, Design for Manufacturing
Education
Florida Atlantic University 2013 — 2016
Master's Degree, Mechanical Engineering
University of Miami 2006 — 2010
Bachelor of Science, Biomedical Engineering (Mechanical Concentration)
HeartWare Inc May 2013 - Present
Emergo Group January 2011 - Present
Fresenius Medical Care April 2011 - April 2013
Orthofix Inc April 2010 - 2010
Chattanooga Group 2003 - 2009
Computer Closeouts November 2001 - April 2003
SunTrust Bank February 1996 - November 2001
Olympus America June 1995 - January 1996
Colgate Palmolive January 1993 - June 1995
United States Air Force January 1986 - August 1991
Skills
Medical Devices, ISO 13485, FDA, Quality System, Regulatory Affairs, Sop
Education
DeVry Institute of Technology 1991 — 1994
Engineering, Electronics
Community College of the Air Force 1986 — 1991
Avionics, Aircraft Electronic Systems
Bradley Central
Actavis plc July 2014 - Present
HeartWare Inc April 2013 - July 2014
HeartWare Inc August 2011 - March 2013
HeartWare Inc June 2010 - July 2011
Boston Scientific May 2009 - June 2010
Uniferag, S.L. November 2005 - November 2008
Rubicas Import-Export, S.L. June 2003 - October 2005
MediCuba July 1998 - February 2003
Skills
Data Analysis, Forecasting, Cost Management, Inventory Control, Materials Management, Material Flow, Supplier Evaluation, Transportation Planning, Regulated Industry, Cultural Diversity, Challenge Driven, Global Sourcing, Global Operations, Logistics, Purchasing, Manufacturing, Procurement, Leadership, Supply Chain..., Project Management, Supply Chain Management, Supply Chain, Strategic Sourcing, Negotiation, Quality System, Six Sigma
Education
Colorado Technical University 2011 — 2012
Master of Business Administration (MBA), Logistics and Supply Chain Management
Miami Dade College 2009 — 2010
VESOL Graduate, English Language (REVEST Program)
Higher Institute of International Relations 1984 — 1990
Bachelor of Arts (B.A.), International Relations
Frederic Goodman Fine Jewelers November 2013 - Present
Seeds of Peace October 2014 - December 2014
Kelliher Samets Volk January 2012 - May 2012
Champlain College September 2009 - May 2012
Champlain College September 2011 - December 2011
ECHO Lake Aquarium and Science Center August 2011 - December 2011
HeartWare Inc May 2011 - August 2011
Energy Options Inc. May 2010 - August 2010
Skills
Event Planning, Public Relations, Customer Service, Blogging, Facebook, Time Management, Social Media, Public Speaking, Management, Nonprofits, Editing, Event Management, Social Media Marketing, Social Networking, International Relations, Marketing Strategy, PR Campaign Development, Business Strategy, Foreign Affairs, Foreign Policy Analysis, International Project..., Luxury Brand Marketing, Political Risk Analysis
Education
New York University 2012 — 2014
M.S. in Global Affairs, Private Sector Concentration, Masters Degree
Champlain College 2008 — 2012
Bachelor of Public Relations, Public Relations
HeartWare Inc October 2012 - Present
Boston Scientific October 2010 - February 2012
Boston Scientific August 2005 - October 2010
Boston Scientific February 2004 - August 2005
Boston Scientific September 2000 - February 2004
Skills
Lean Manufacturing, Critical..., Project Management &..., Good Manufacturing..., Six Sigma, Manufacturing, Problem Solving, Medical Devices, Supervisory Skills, Quality Systems, FDA, ISO, Continuous Improvement, 5S, Kaizen, SAP, Compliance, Root Cause Analysis, Process Improvement, Training Delivery, Train the Trainer, Employee Engagement, Learning Management..., Facility Relocation, Technology Transfer, Project Management, Quality System, GMP, Training, Operations Management, CAPA, V&V, ISO 13485, Validation, Quality Assurance, Software Documentation, Employee Training, Design of Experiments, Leadership, Program Management, Quality Control, Quality Management, Minitab, Cross-functional Team..., DMAIC, Product Development, MRP, Process Engineering, SPC, Quality Auditing
Education
Miami Dade College 2011 — 2014
BAS- SUPERVISION & MANAGEMENT, Opr Management, 3.56
FIU 2009 — 2013
Human Resources Management/Personnel Administration, General
Miami Dade College 2008 — 2011
Associate of Arts (A.A.), Business Administration and Management, General, Graduated with Honors
Baker University 2010 — 2010
Certified, Six Sigma Green Belt, ASQ
Bolton Medical April 2015 - Present
Heather Harries Medical Device Consulting, Inc. November 2009 - Present
Johnson & Johnson November 2012 - April 2015
Cordis July 2010 - November 2012
HeartWare Inc January 2008 - September 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY May 2005 - December 2007
Cordis March 2003 - May 2005
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY December 2000 - March 2003
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1998 - December 2000
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1997 - July 1998
Skills
Healthcare, R&D, Medical Devices, Quality Assurance, Program Management, Product Development, Quality Engineering, Quality Auditing, ISO standards, Risk Management, Change Management, Change Control, FDA, Engineering, Problem Solving, Testing, Technical Writing, Design Control, ISO 13485, Cross-functional Team..., Quality Management, Product Launch, Project Planning, Biotechnology, Quality System, FMEA, Manufacturing, Design of Experiments, Root Cause Analysis, ISO, Validation, Quality Control, CAPA, V&V, Team Leadership, Regulatory Affairs, Process Engineering, GMP, Sop, Software Documentation, Minitab, DMAIC, ISO 14971, Process Simulation, 21 CFR Part 11, Biomedical Engineering, SPC, Commercialization, Technology Transfer, Leadership
Education
Florida International University 1999 — 2001
M.S., Engineering Management
Dartmouth College 1995 — 1997
M.S., Biomaterials Engineering
Duke University 1991 — 1995
BS, Biomedical and Mechanical Engineering and Materials Science
Ellenville Central 1979 — 1991
High School Degree, General
HeartWare Inc April 2011 - Present
Foliage September 2010 - April 2011
Haemonetics October 2007 - September 2010
Analog Devices February 1997 - October 2007
Analog Devices January 1986 - January 1996
Dectroswiss 1985 - 1986
Asulab 1981 - 1985
Skills
Analog Circuit Design, Embedded Software, Testing, Embedded Systems, Digital Signal..., Electronics, C, Medical Devices, System Architecture, ASIC, Labview, Device Drivers, Digital Circuit Design, Mixed Signal, PCB design, Debugging, Analog, Hardware, System Design, Product Development, Firmware, Design Control, Integrated Circuit..., Digital Signal..., Design for Manufacturing, Signal Processing, Hardware Architecture, IC, Embedded SW development, R&D, Engineering, FDA, Cross-functional Team..., Validation, fmea, FTA, Test Driven Development, Matlab
Education
Duke University 1974 — 1978
BME, Biomedical Engineer
Cordis July 2013 - Present
HeartWare Inc January 2011 - June 2013
Cordis January 2007 - January 2011
Cordis August 2003 - January 2007
Cordis August 2002 - August 2003
Cordis February 2001 - August 2002
Janssen Pharmaceuticals November 1997 - February 2001
Ethicon, Inc. October 1993 - November 1997
Skills
Process Engineering, Process Improvement, Maintenance Engineering, Validation Engineering, Project Management, Process Transfer, Manufacturing Operations, Start-up Implementation, Lean Manufacturing, Six Sigma, ME2, Recruitment and Team..., Medical Devices, Pharmacueticals, CAPA, Process Simulation, V&V, Design Control, Engineering, ISO 13485, People Development, FDA, Integration, Validation, Manufacturing, Design of Experiments, FMEA, Minitab, Quality Assurance, Design for Manufacturing, Root Cause Analysis, DMAIC, Manufacturing..., SPC, ISO 14971
Education
Florida International University - College of Business Administration 2004 — 2005
Executive MBA
Universidad Politécnica de Puerto Rico 1991 — 1994
Mechanical Engineering
Universidad Nacional de Trujillo 1988 — 1991
Engineering
HeartWare Inc December 2013 - Present
Choate, Hall & Stewart January 2010 - December 2013
Choate, Hall & Stewart May 2008 - August 2008
The Hon. David S. Doty, Federal District Court of Minnesota May 2007 - August 2007
Consumer Bankruptcy Assistance Project (CBAP) August 2005 - August 2006
Skills
Private Equity, Corporate Law, Securities Regulation, Venture Capital, Cross-border M&A, Securities, Corporate Governance, Start-ups, Corporate Finance, Mergers & Acquisitions
Education
University of Notre Dame Law School 2006 — 2009
J.D., Law
Boston College 2001 — 2005
B.A., Political Science; Theology
University of Oxford 2003 — 2004
JYA, Politics, Philosophy and Economics (PPE)
St. Paul Academy & Summit School 1995 — 2001
College Prep
Boston Scientific July 2014 - Present
J.Crew November 2012 - Present
Fairlife, LLC August 2012 - Present
HeartWare Inc May 2013 - July 2014
Conventures, Inc. January 2013 - March 2013
Westin Hotels & Resorts June 2011 - September 2011
Starwood Hotels & Resorts Worldwide, Inc. September 2010 - June 2011
Starwood Hotels & Resorts Worldwide, Inc. October 2009 - September 2010
Starwood Hotels & Resorts Worldwide, Inc. September 2008 - January 2009
Skills
Event Management, Customer Service, Event Planning, PowerPoint, Microsoft Word, Meeting Planning, Microsoft Office, Hospitality Industry, Marketing, Microsoft Excel, Hospitality, Delphi, Leadership, Marketing Communications
Education
Endicott College 2004 — 2009
Bachelor of Arts (BA), Liberal Arts and Sciences/Liberal Studies
HeartWare Inc May 2015 - Present
EMcomm September 2012 - Present
Five Cent Sound Magazine September 2013 - Present
Music-Mine September 2014 - Present
AMP'd Tour Marketing September 2014 - May 2015
Paul's Diner 2009 - September 2014
DSI Marketing Communications June 2013 - August 2013
DSI Marketing Communications May 2013 - August 2013
Skills
Marketing Communications, Creative Concept Design, Copywriting, Advertising, Creative Concepting, Organization Skills, SLR Photography, Adobe PhotoShop, Adobe InDesign, Logo Design, Microsoft Office, Social Media, Microsoft Excel, Graphic Design, Adobe Illustrator, Adobe Creative Suite, Twitter Marketing, Blogging, Reception
Education
Emerson College 2012 — 2015
Bachelor's Degree, Marketing Communications
HeartWare Inc June 2010 - Present
Teva Pharmaceuticals April 2005 - July 2010
Ivax / DVM Pharmaceuticals August 1998 - April 2005
Skills
Outlook, Medical Devices, Microsoft Word, Microsoft Excel, Microsoft Office, Pharmaceutical Industry, PowerPoint, Software Documentation, Microsoft Publisher, CA Clarity, Quality Assurance, Customer Service, Data Analysis, Troubleshooting, Visio, ISO 13485, Lotus Notes
Education
Florida Atlantic University 2013 — 2013
Project Management Certificate, Project Management
Miami Dade College 2009 — 2012
Associate of Arts (A.A.), English Language and Literature, General
HeartWare Inc January 2010 - Present
Ortho Clinical Diagnostics January 2008 - January 2010
Skills
Event Planning, Change Management, Employee Training, Public Speaking, Event Management, Project Management, Analysis, Marketing, Marketing Strategy, Microsoft Excel, Microsoft Office, PowerPoint, Research, Social Networking, Strategic Planning, Training
Education
Benjamin Cardozo School of Law 1995 — 1998
J.D., Law
City University of New York-Brooklyn College 1989 — 1993
BA, psych and Philosophy
W. L. Gore & Associates February 2015 - Present
HeartWare Inc February 2013 - February 2015
HeartWare Inc July 2011 - February 2013
Purdue University July 2009 - July 2011
McKinney Precision Tile April 2008 - December 2008
BYU-Idaho April 2008 - December 2008
Woodgrain Millwork December 2007 - April 2008
Idaho National Laboratory April 2007 - July 2007
Skills
Labview, CAD, Medical Devices, CFD, Solidworks, Testing, Validation, PIV, PLC Programming, Heat Transfer, Fluid Dynamics, Minitab, GD&T, Design of Experiments, Bench Testing, Design Verification..., Test Development, Engineering, Design Control, FDA, Product Development, ISO 13485, Fluid Mechanics, Biomedical Engineering, R&D, FMEA
Education
Purdue University 2009 — 2011
MS, Mechanical Engineering
Brigham Young University - Idaho 2002 — 2008
BS, Mechanical Engineering
HeartWare Inc October 2010 - Present
Republic Services, Inc. March 2007 - December 2009
Republic Services, Inc. January 2000 - January 2004
Republic Services, Inc. October 1997 - January 2000
Sensormatic Electronics Corporation January 1997 - October 1997
InPhyNet Medical Management January 1996 - January 1997
InPhyNet Medical Management January 1995 - January 1996
Skills
General Ledger, Essbase, Accounts Payable, Financial Reporting, Accounts Receivable, Cash Flow, Microsoft Excel, Spreadsheets, Acquisitions, Microsoft Word, Microsoft Office, Software Installation, Financial Analysis, Sarbanes-Oxley Act, Forecasting, Account Reconciliation, Variance Analysis, Budgets, Outlook, Management, Financial Accounting, Internal Controls, Finance, Accounting, Financial Statements, Income Statement, GAAP, Cost Accounting, Analysis, Process Improvement, Fixed Assets, SEC filings, P&L, Business Process...
Education
Florida Atlantic University 1996 — 1996
B.B.A., Accounting
Florida State University - College of Business 1990 — 1994
B.S., Finance
HeartWare Inc December 2014 - Present
HeartWare Inc November 2013 - December 2014
BackOffice Associates December 2010 - October 2013
Automation Engineering March 2010 - December 2010
Bank of New York Mellon May 2007 - 2009
Brooks Automation December 2005 - April 2007
Applied Materials 2007 - 2007
Brooks Automation March 2003 - December 2005
FASTech, Inc. 1997 - 1999
LCC 1996 - 1997
Skills
Program Management, Project Management, Management, SAP, Business Analysis, SDLC, Business Intelligence, Requirements Analysis, Enterprise Software, Software Project..., Software Development, Agile Methodologies, ERP, PMP, Databases, SQL, Scrum, Project Portfolio..., Vendor Management, Cross-functional Team..., Enterprise Architecture, Requirements Gathering, Process Improvement, Budgets, Integration, Quality Management, Product Management, Strategy, Manufacturing
Education
Babson College - Franklin W. Olin Graduate School of Business 2004 — 2008
MBA
Tufts University 1990 — 1994
B.S
Chapel School 1985 — 1990
High School
HeartWare Inc October 2010 - Present
Walgreens February 2007 - October 2010
Johnson & Johnson - Cordis 2005 - 2007
Johnson & Johnson 2005 - 2005
Skills
Medical Devices, Six Sigma, Lean Manufacturing, FDA, Minitab, Root Cause Analysis, Supply Chain Management, Continuous Improvement, CAPA, Engineering, Industrial Engineering, Cross-functional Team..., Quality System, Design of Experiments, DMAIC, Manufacturing, Validation, Kaizen
Education
University of Florida 2009 — 2011
Engineering Management
Florida International University 2003 — 2005
Industrial & Systems Engineering
Universidad de Los Andes 2001 — 2002
Bachelor's Degree, Industrial Engineering
RARE-data = Solutions January 2015 - Present
HeartWare, Inc January 2011 - Present
Invisiwave March 2009 - March 2010
HeartWare, Inc October 1991 - January 2009
Duke University Medical Center January 1990 - October 1999
Skills
DICOM, Medical Imaging, Cardiology Information..., Healthcare Information..., Agile Application..., IT Project & Program..., Software Development
Education
Duke University - The Fuqua School of Business 1996 — 1997
Master of Business Administration (MBA)
Duke University 1988 — 1990
Master of Science Engineering, Biomedical Engineering (BME)
Duke University 1983 — 1986
Bachelor of Science (BSE), Biomedical & Electrical Engineering (BME/EE)
HeartWare Inc April 2015 - Present
ChenMed August 2014 - April 2015
Miami Children's Hospital April 2014 - March 2015
Essia Health April 2014 - August 2014
University of Miami Tissue Bank March 2013 - February 2014
Skills
Minitab, Solidworks, Microsoft Word, Microsoft Excel, Matlab, Biomedical Engineering, Labview, Statistics, PowerPoint, MS Project, Team Leadership, Spanish, Medical Devices, Finite Element Analysis, Teamwork, English, Orthopedic, Lifesciences, Critical Thinking, Cell Biology, Spine, Time Management, GMP, Tissue Engineering, FDA, Chromatography, Physiology, Analytical Skills, Hospitals, Medical Terminology, HIPAA, EMR, SolidWorks, Research, Data Analysis, Leadership, Healthcare, Engineering, Design Control, Biomaterials, R, Quality Assurance
Education
Florida International University 2015 — 2016
Master of Engineering (MEng), Mechanical Engineering
Florida International University 2008 — 2013
Biomedical Engineering
St. Brendan Highschool 2004 — 2008
High School Diploma
HeartWare Inc May 2015 - Present
OrbusNeich May 2011 - May 2015
OrbusNeich July 2006 - May 2011
FIU Physiology Engineering Lab September 2005 - August 2006
Skills
Biomedical Engineering, R&D, Medical Devices, Six Sigma, Manufacturing, Stents, Design Control, Microsoft Office, Quality Systems, Product Development, Validation, Engineering, GMP, Program Management, Excel, Cardiology, CAD, Team Leadership, Cell Culture, Process Improvement, Problem Solving, AutoCAD, Word, Product Management, Process Engineering, Budgeting, PowerPoint, Quality System, V&V, Commercialization, FMEA, CAPA, Product Launch, Biomaterials, Design of Experiments, Market Development
Education
Florida International University 2009 — 2009
Six Sigma Green Belt, DMAIC
Florida International University 2003 — 2006
BS, Biomedical Engineering
Broward College 2001 — 2003
AA, Pre-medicine/ Biology
HeartWare Inc March 2012 - Present
D.O.O.R. 2009 - Present
Univision May 2011 - March 2012
Hospitality Purveyors Inc., an affiliate Sandals® Beach Resorts October 2007 - November 2009
Norwegian Cruise Line November 1992 - October 2007
Skills
Event Management, Contract Negotiation, Project Management, Management, Sales Operations, Marketing, Training, Business Development, Sales, Event Planning, Purchasing, Sourcing, Recruiting, Retail, Tourism, Analysis, Customer Service, Logistics, Negotiation, Supply Chain
Education
Barry University
Bachelor of Science, Professional Business Administration
Barry University
Human Resources Certificate
HeartWare Inc March 2015 - Present
HeartWare Inc December 2013 - March 2015
HeartWare Inc August 2011 - May 2013
Qsource Networks November 2007 - June 2011
USAF May 2005 - May 2007
Skills
Microsoft Exchange, Process Improvement, Cloud Computing, Networking, Servers, Active Directory, Network Security, SaaS, Data Center, Integration, VMware, Software Documentation, Managed Services, Leadership, Professional Services, Windows Server, Disaster Recovery, VoIP, Microsoft Technologies, New Business Development, Hardware, Software Development, Software Validation, Regulatory Compliance, Customer Service, Customer Satisfaction, Process Excellence, Software Deployment, Training Delivery, ERP Software, Oracle Agile PLM, Cisco Technologies, QAD, Camstar, MES, Lean Manufacturing, Medical Devices
Education
Community College of the Air Force 2005 — 2007
AAS, Information Systems
The University of Georgia 1999 — 2003
BS, Psychology
HeartWare Inc March 2014 - Present
HeartWare Inc June 2011 - February 2014
Draper Laboratory September 2009 - May 2010
Skills
Biomedical Engineering, Medical Devices, V&V, FDA, Matlab, Design Control, ISO 13485, Validation
Education
Boston University 2006 — 2010
BS, Biomedical Engineering
HeartWare Inc July 2015 - Present
NxStage Medical July 2013 - July 2015
NxStage Medical July 2012 - July 2013
NxStage Medical March 2011 - July 2012
NxStage Medical September 2008 - March 2011
Moldflow 2007 - August 2008
Moldflow Corporation 2004 - 2007
Monstermoving 2003 - 2004
Aspect Medical Systems 2000 - 2003
Nova Biomedical Corporation 1992 - 2000
Skills
Forecasting, Budgeting, Excel, Account Management, Marketing Strategy, Accounting, Budgets, Analysis, Business Analysis, ERP, CRM, Finance, Financial Analysis, Leadership, Management, Managerial Finance, Manufacturing, Marketing, Microsoft Excel, Process Improvement, Sales, Sales Operations, Sales Process, Salesforce.com, Strategic Financial..., Time Management
Education
Bentley University
BS, Accounting
HeartWare Inc January 2011 - Present
American Medical Depot January 2007 - January 2011
General Stair Corporation April 2005 - January 2007
Magnivision, Inc. March 1993 - March 2005
Skills
Performance Management, Employee Benefits, Medical Devices, Payroll, International HR, Training, Process Improvement, Complaint Management, Coaching, Contract Negotiations, Employee Relations, Employment Law, HRIS, Workers' Compensation, Safety Management, Personnel Management, Workers Compensation
Education
Barry University 1998 — 2001
Bachelor of Business Administration, Human Resources Management
Keiser College 1996 — 1996
Human Resources Management/Personnel Administration, General
Miami Dade College 1979 — 1982
Associate of Arts (AA)
HeartWare Inc February 2012 - Present
Pall Aeropower Corporation February 2011 - February 2012
Pall Aeropower Corporation June 2006 - February 2011
Real-Time Laboratories May 2004 - June 2006
ECOA Industrial Products, Inc. September 2001 - April 2004
Bishamon Industries Corp. March 1999 - September 2001
Skills
Engineering, Design for Manufacturing, FMEA, Engineering Management, Root Cause Analysis, Finite Element Analysis, Kaizen, CAD, GD&T, Six Sigma, Aerospace, Mechanical Engineering, Medical Devices, Geometric Dimensioning..., Quality System, Design of Experiments
Education
Florida International University 1996 — 1998
Bachelor of Science (B.S.), Mechanical Engineering, 3.69 GPA (cum Laude)
Miami Dade College 1992 — 1996
Associate of Arts (AA), Engineering Science, 3.97 GPA
HeartWare Inc February 2015 - Present
HeartWare Inc May 2014 - January 2015
Nipro Diagnostics (formerly Home Diagnostics) January 2012 - May 2014
FIU 2011 - 2013
Florida International University July 2010 - August 2012
Mount Sinai Medical Center February 2011 - January 2012
Miami Dade College January 2008 - July 2010
Miami Dade College April 2010 - June 2010
Skills
Research, Matlab, PowerPoint, Statistics, Microsoft Excel, Microsoft Office, Solidworks, Data Analysis, Biomedical Engineering, SPSS, Quality Assurance, DHF, Root Cause Analysis, Failure Modes, FMEA, Cell Culture, Laboratory, Minitab, Labview, Science, Training, Teamwork, Public Speaking, FDA, Medical Devices
Education
Florida International University 2014 — 2015
Master of Science in Engineering Management (MSEM)
Florida International University 2011 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Miami Dade College 2009 — 2011
Associate of Arts and Sciences (A.A.S.)
HeartWare Inc August 2013 - Present
Medtronic Spine & Biologics July 2012 - July 2013
Medtronic Spine & Biologics August 2010 - June 2012
Medtronic Spine & Biologics November 2008 - August 2010
Clemson University October 2006 - August 2008
Robert Bosch Corp. August 2005 - December 2005
Skills
Case and Tray Design, Sterile Barrier System..., Distribution Simulation..., Medical Device Packaging, Medical Device Delivery..., Traceability, CPP, Medical Devices, Packaging, Design Control, Packaging Engineering, Validation, FDA, ProE, Creo, Equipment Qualification, Testing, Six Sigma
Education
Clemson University 2003 — 2008
BS, Packaging Science
Luminis Partners May 2015 - Present
MedTech Strategies, LLC November 2014 - Present
HeartWare Inc September 2013 - November 2014
Biogen Idec February 2011 - September 2013
DePuy Spine, a Johnson and Johnson Company April 2009 - February 2011
DePuy Spine, a Johnson and Johnson Company May 2006 - June 2009
DePuy Spine, a Johnson and Johnson Company May 2003 - May 2009
Health Advances 2001 - 2003
Guidant 2000 - 2000
Regeneration Technologies (University of Florida Tissue Bank) January 1997 - August 1999
Skills
Healthcare, Strategy, Leadership, Strategic Planning, Business Development, Market Development, Marketing Strategy, Medical Devices, Competitive Analysis, Product Development, Commercialization, Product Launch, Global Marketing, Cross-functional Team..., Product Management, Product Marketing, Market Analysis, Surgical Instruments, Capital Equipment, Life Sciences
Education
Dartmouth College - The Tuck School of Business at Dartmouth 1999 — 2001
MBA
Dartmouth College 1990 — 1995
BA, Biology
HeartWare Inc August 2010 - Present
HeartWare Inc August 2010 - September 2011
The College of New Jersey May 2009 - August 2010
Medtronic 2006 - 2009
Cardiac Consultants, Inc January 2005 - 2009
Education
Seton Hall University 2003 — 2005
Master's Degree, Adult Nurse Practitioner
US Army - Academy of Health Sciences 1994 — 1996
Licensed practice nurse, Nursing Science
Rutgers, The State University of New Jersey-Newark 1999 — 2002
Bachelor's Degree, Nursing Science
Brookdale Community College 1996 — 1999
Associate's Degree, Nursing Science
HeartWare Inc May 2013 - Present
Heartware Inc January 2012 - May 2013
HeartWare Inc February 2011 - January 2012
Kelly Scientific Resources June 2010 - January 2011
University of Miami October 2008 - June 2010
Johnson & Johnson April 2007 - October 2008
Skills
Validation, FDA, V&V, Medical Devices, CAPA, Process Improvement, Process Engineering, Problem Solving, Product Transfer, Document Review, Document Drafting, 21 CFR Part 280, Six Sigma, Project Management, Water Systems, Biomedical Engineering, Investigation, Risk Assessment, Minitab, Design of Experiments, DMAIC, Quality System, GMP, Root Cause Analysis, Process Simulation, Change Control
Education
DeVry University's Keller Graduate School of Management-Florida 2013 — 2015
Master of Business Administration (MBA)
Keller Graduate School of Management of DeVry University 2013 — 2014
Graduate Certificate, Project Management
DeVry University 2005 — 2008
BS, Biomedical Engineering Technology
HeartWare Inc February 2011 - Present
Ethicon Endo-Surgery August 2005 - February 2011
Ethicon Endo-Surgery, A Johnson & Johnson Company 2005 - February 2011
Smiths Medical 2002 - 2005
Skills
Orthopedic, Urology, Oncology, Clinical Research, Biotechnology, Market Access, Healthcare Reimbursement, Health Policy, Pharmaceutical Sales, Product Launch, Neurology, Sales Operations, Capital Equipment, Clinical Trials, Operating Room Sales, Operating Room, Surgeons
Education
California State University-Fullerton
Bachelor of Business Administration (B.B.A.)
University of Southern California
HeartWare Inc February 2012 - Present
STERIS Corporation September 2005 - Present
Hanger Orthopedic Group September 2003 - Present
Falmouth Academy September 2013 - Present
Atrius Health January 2012 - September 2013
Hayes Lemmerz International 2006 - 2009
Palmer & Dodge LLP 2002 - 2004
New Directions 2002 - 2003
KPMG June 1994 - September 2002
PwC September 1975 - May 1994
Skills
Due Diligence, Mergers, Auditing, Acquisition Integration, Venture Capital, Mergers & Acquisitions, Start-ups, Corporate Governance, Strategic Planning, Finance, Business Development, Strategy, Financial Analysis, Business Strategy, Management Consulting, Business Planning, Financial Modeling, Corporate Finance, Cross-functional Team..., Business Process..., Restructuring, Executive Management
Education
Boston College 1972 — 1975
Bachelor's degree, Accounting
Chamberlayne Junior College 1970 — 1972
AS, Retailing
Epic July 2015 - Present
HeartWare Inc January 2015 - June 2015
A.I. Dupont Hospital for Children March 2014 - September 2014
Delavau LLC November 2011 - September 2014
Skills
Biomedical Engineering, Matlab, SolidWorks, Medical Devices, Biotechnology, SPSS, OpenSim, Biomechanics, Microsoft Excel, PowerPoint, AutoCAD, GMP, Laboratory, Data Analysis, Validation, Research, Microsoft Office, Public Speaking, R&D
Education
Drexel University 2013 — 2015
Master of Science (M.S.), Biomedical/Medical Engineering
Franklin & Marshall College
Bachelor's degree, Chemistry/Biochemistry
Fresenius Medical Care November 2014 - Present
Validant August 2014 - November 2014
DOHMEN March 2014 - June 2014
Maetrics, LLC January 2013 - October 2013
HeartWare Inc March 2011 - March 2012
Cordis Corporation February 2005 - March 2011
Baxter Healthcare Corporation January 1999 - January 2001
Skills
Medical Devices, Validation, ISO 13485, FDA, Quality System, Quality Assurance, CAPA, Quality Management, 21 CFR, GMP, ISO 14971, V, Complaint Management, Software Documentation, Sop, V&V, Regulatory Affairs
Education
Florida International University 2006 — 2008
Bachelors, International Business and Management
HeartWare Inc September 2015 - Present
Goodwin Biotechnology, Inc. October 2013 - Present
Medical Products Laboratories, Inc. January 2011 - July 2013
FLUID ENERGY PROCESSING AND EQUIPMENT Company February 2010 - July 2010
Thomas Medical Products, a GE Healthcare Company November 2008 - November 2009
NATIONAL LABEL COMPANY January 1998 - February 2008
Skills
CAPA, V&V, GMP, FDA, ISO 13485, Change Control, Validation, Sop, Medical Devices, Quality System, Regulatory Affairs, 21 CFR Part 11, Quality Assurance, Manufacturing, GLP, Design Control, Pharmaceutical Industry, ISO 14971, Technology Transfer, Quality Auditing, FDA GMP, Quality Control, Root Cause Analysis, Regulatory Submissions, Quality Management, ISO, Pharmaceutics, Computer System..., HPLC, Biotechnology, Analytical Chemistry, Cleaning Validation, Six Sigma, LIMS, UV/Vis, GxP, Regulatory Requirements, Chemistry, SOP
Education
Temple University 2008 — 2009
Medical Devices Certificate
Drexel University 1993 — 1997
BS, Chemical Engineer
Katun Corporation September 2013 - December 2013
University of Minnesota September 2011 - December 2013
Frommer Lawrence & Haug LLP May 2013 - August 2013
University of Minnesota Office of Technology Transfer September 2012 - May 2013
Holaira February 2011 - May 2013
Hennepin County Courts June 2012 - August 2012
HeartWare Inc 2011 - 2011
Calypso Medical May 2006 - August 2010
Boston Scientific January 1999 - March 2006
InControl, Inc. 1997 - 1998
Skills
Biomedical Engineering, Medical Devices, Design of Experiments, R&D, Design Control, FDA, Patents, Statistics, Polymers, Intellectual Property
Education
University of Minnesota 2011 — 2013
J.D., Law, 3.548 magna cum laude
University of Washington 2000 — 2004
Master of Medical Engineering, Bioengineering, 3.66
Brigham Young University 1990 — 1997
B.S., Chemical Engineering, 3.14
Bellevue Senior High School 1986 — 1990
HeartWare Inc June 2010 - Present
Parkson Corporation June 2009 - January 2010
B/E Aerospace May 2004 - April 2009
Infotech Enterprises Limited March 2002 - December 2006
UTC Power July 2003 - December 2003
Skills
Mechanical Engineering, Solidworks, Systems Engineering, Process Engineering, Unigraphics, Engineering Management, Composites, Finite Element Analysis, R&D, Engineering, Pro Engineer, Manufacturing, CAD, Lean Manufacturing, AutoCAD, Six Sigma, Sheet Metal, Product Development, Project Engineering, Design for Manufacturing, Aerospace, Quality System, Kaizen, Manufacturing..., Root Cause Analysis, FMEA, GD, Medical Devices, Design of Experiments, Product Design, Machining, FDA, ANSYS, Continuous Improvement, Design Engineering, Automotive, Program Management, V, Inventor, Solid Modeling, Teamcenter, CAPA, ISO 13485, Design Control, Testing, Machine Design, PDM, Industrial Engineering, SolidWorks, PTC Creo
Education
Florida International University 2014 — 2015
Master of Business Administration (M.B.A.), Business Administration and Management, General
Sri Venkateswara University 1995 — 1999
B.S, Mechanical Engineering
HeartWare Inc July 2014 - Present
Boston Scientific July 2012 - June 2014
Boston Scientific September 2010 - July 2012
Stryker August 2004 - September 2010
Cardinal Health September 2002 - July 2004
Cardinal Health September 2001 - August 2002
Education
Cornell University 1997 — 2001
Cordis July 2014 - Present
HeartWare Inc July 2012 - July 2014
Kelly Scientific Resources March 2011 - July 2012
Westside Regional Medical Center October 2010 - October 2011
Abiomed, Inc August 2007 - January 2010
Cordis Corporation a Division of Johnson & Johnson August 2004 - August 2007
Florida Medical Center March 2000 - August 2004
Delray Medical Center September 1996 - March 2000
Royal Victoria Hospital May 1994 - July 1996
Medical Center Hospital November 1994 - February 1995
Skills
Medical Devices, Critical Care, Cardiology, Interventional..., Hospitals, Nursing, Healthcare, ICU, Cardiac Surgery, Vascular, Cath Lab, Interventional Radiology, FDA, Clinical Trials, Acute Care, ACLS, Leadership, Quality Assurance, ISO 13485, Surgery, Clinical Research, Market Development, Capital Equipment, Product Launch
Education
Capella University 2005 — 2008
MBA, Business
University of Manitoba 1988 — 1989
AICNP, Adult Intensive Care Nursing Program
Western University 1983 — 1987
BScN, Nursing
HeartWare Inc November 2011 - Present
OmniGuide August 2010 - November 2011
Massachusetts Institute of Technology June 2008 - June 2010
Spirit AeroSystems June 2009 - December 2009
L-3 Communications June 2005 - June 2008
Skills
Product Development, Product Management, Medical Devices, Six Sigma, Manufacturing, Design of Experiments, Cross-functional Team..., Strategy, Product Design, Mechanical Engineering, Management, Program Management, R&D, Engineering, Lean Manufacturing, Engineering Management, Optics, ENT, Process Improvement, Product Launch, Product Marketing, Project Management, Design for Manufacturing, Solidworks, Surgery, Continuous Improvement, Biomedical Engineering
Education
Massachusetts Institute of Technology 2008 — 2010
MS, Mechanical Engineering
Massachusetts Institute of Technology - Sloan School of Management 2008 — 2010
MBA, Operations and Strategy
Cornell University 2003 — 2005
BS, Mechanical Engineering
HeartWare Inc July 2012 - Present
Caliper Life Sciences November 2000 - December 2011
Iconomy.com, Inc. January 2000 - November 2000
Independent Consultant January 1999 - December 1999
Elcom Systems 1997 - 1998
Geerlings & Wade, Inc. 1995 - 1996
Arthur Andersen LLP 1986 - 1995
Skills
Mergers, Venture Capital, Due Diligence, SEC filings, Accounting, Financial Analysis, Financial Modeling, Revenue Recognition, Restructuring, Forecasting, Biotechnology, Strategic Planning, Start-ups, Budgets, Executive Management, Mergers & Acquisitions
Education
Bentley University 1982 — 1986
BS, Accounting
HeartWare Inc March 2014 - Present
HeartWare Inc January 2011 - February 2014
Biomet 3i October 2008 - January 2011
GCI Biotech, Inc June 2006 - October 2008
Boston Scientific 2006 - 2008
Skills
Biomedical Engineering, CAPA, Continuous Improvement, DMAIC, Design Control, Design of Experiments, Engineering, FDA, FMEA, GMP, ISO, ISO 13485, ISO 14971, Lean Manufacturing, Manufacturing, Medical Devices, Minitab, Process Engineering, Product Development, Program Management, Quality Assurance, Quality System, Root Cause Analysis, SPC, Six Sigma, Solidworks, Testing, V, Validation
Education
Florida International University 2009 — 2011
Master, Engineering
Florida International University
Bachelor of Science, Biomedical Engineering
Medtronic May 2015 - Present
HeartWare Inc March 2015 - May 2015
NeuroVigil July 2014 - April 2015
Florida International University August 2013 - May 2014
Starbucks June 2012 - February 2014
Florida Atlantic University May 2013 - June 2013
Florida International University January 2012 - August 2012
Skills
PowerPoint, Customer Service, Research, Matlab, Microsoft Office, Microsoft Word, Data Analysis, Spanish, Teamwork, Microsoft Excel, Public Speaking, Event Planning, Time Management, Social Networking, MikroBasic, Signal Processing, Programming, Leadership, Statistics, Facebook, Social Media, QuickBooks, Python, Final Cut Pro, Machine Learning, Software Documentation, Data Mining
Education
Florida International University 2011 — 2014
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Boston University
HeartWare Inc 2013 - Present
Kahane & Associates, P.A. June 2011 - June 2013
Kahane & Associates, P.A. December 2008 - June 2011
Rewards Network April 2007 - August 2008
Keystone Title & Escrow, Inc May 2004 - April 2007
Skills
Real Estate, Real Estate Transactions, Single Family Homes, Foreclosures, REO, Commercial Real Estate, Property, Construction, Contract Negotiation, Marketing, Sales, Due Diligence, Strategic Planning
Education
Keller Graduate School of Management of DeVry University 2006 — 2007
Master of Project Management, Project Management
Florida International University 2000 — 2004
Bachelor of Arts (B.A.), International Relations and Affairs
Sir Arthur Lewis Community College 1998 — 2000
GCE Certificate, Economics, Spanish
ElectroSurge, LLC January 2010 - Present
HeartWare Inc July 2011 - June 2014
Depuy Mitek/ Johnson & Johnson April 2006 - June 2011
Bard EP, a division of CR Bard June 2004 - May 2006
Boston Scientific 2005 - 2005
Aurora Imaging Technology, Inc. 2000 - 2003
Smith & Nephew Endoscopy 1998 - 2000
Boston Scientific 1991 - 1995
Microwave Medical Systems 1987 - 1990
Skills
Medical Devices, Design Control, Product Development, Cross-functional Team..., R&D, Biomedical Engineering, FDA, Biotechnology, Technology licensing &..., Technology Transfer, Catheters, Product Launch, Healthcare, Lifesciences, Radiofrequency ablation..., ISO 13485, Capital Equipment, Quality System, Start-ups, Validation, Management, Manufacturing, V&V
Education
Babson College - Franklin W. Olin Graduate School of Business
MBA (with Honors), Technology Management, Lifesciences
Boston University
MS Biomedical Engineering, Neuromuscular signal processing
The University of Connecticut
BSEE, Biomedical Engineering
HeartWare Inc April 2011 - Present
HeartWare Inc March 2009 - May 2011
TransMedics, Inc. April 2006 - February 2009
Draeger Medical Systems 2004 - 2006
Siemens Medical Systems July 1986 - July 2004
Analogic May 1984 - July 1986
Norland Corporation June 1981 - May 1984
Cordis Corporation July 1978 - June 1981
Skills
Medical Devices, Engineering, PCB design, Troubleshooting, Electrical Engineering, Design Control, FMEA, ISO 13485, ISO 14971, Project Management, Testing, R&D, Quality Assurance, GMP, V&V, CAD, Electronics, Medical Monitoring, Analog, Cross-functional Team..., CAPA, PCB Design
Education
Duke University 1974 — 1978
BSE, Biomedical Engineering/Electrical Engineering
Micell Technologies November 2011 - Present
Teleflex Medical March 2007 - November 2011
HeartWare Inc. August 2006 - March 2007
Boston Scientific October 2005 - August 2006
Cordis Johnson & Johnson June 2000 - October 2005
Skills
ISO 13485, Medical Devices, FDA, Design Control, V&V, CAPA, Quality System, Quality Assurance, Validation, Minitab, Gage R, Computer System..., GLP
Education
Florida International University 2000 — 2003
MS, Biomedical Engineering
Florida International University 1996 — 2000
BS, Electrical Engineer
HeartWare Inc May 2015 - Present
HeartWare Inc August 2012 - April 2015
Caliper Life Sciences, a PerkinElmer Company 2007 - 2012
RenaMed 2006 - 2006
DUSA Pharmaceuticals 2000 - 2005
State Street Bank 1996 - 2000
Skills
Forecasting, Mergers & Acquisitions, SEC filings, Accounting, Financial Modeling, Strategic Financial..., Finance, Microsoft Excel, Equities, Strategy, Interpersonal..., Consolidation, Advanced Excel Modeling, Equity Compensation, Acquisition-Divestiture..., Strong Interpersonal..., Strong Communication..., Stong Presentation..., SEC Reporting, Financial Reporting &..., Forecasting Modeling, Communication Skills, Management, Global Revenue Planning, Develop Sales..., Develop Sales...
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1994 — 1996
Masters, Finance
Norwich University 1983 — 1987
BS, Accounting
Aspect Software May 2014 - Present
Aspect Software April 2013 - May 2014
Aspect Software November 2012 - April 2013
Aspect Software May 2009 - November 2012
HeartWare Inc February 2009 - May 2009
IONA Technologies March 2006 - January 2009
3Com Corporation May 2005 - March 2006
Skyworks Solutions Inc. August 2002 - May 2005
Allmerica Financial Corporation May 1998 - August 2002
Skills
Financial Reporting, SOX, Accounting, Mergers, SEC reporting, Forecasting, Process Improvement, Financial Analysis, Financial Accounting, Sarbanes-Oxley Act, SEC filings, Revenue Recognition, Auditing, Internal Controls, Financial Modeling, US GAAP, Sarbanes-Oxley, Due Diligence, Treasury, GAAP, PeopleSoft, Accounts Payable, Cash Management, IFRS, Hyperion Enterprise, Consolidation, Managerial Finance, Variance Analysis, Finance, Budgets, Payroll, Management, SAP, Mergers & Acquisitions, Financial Statements, Cost Accounting, Account Reconciliation, Strategic Financial..., Acquisition Integration, General Ledger, Internal Audit, Essbase, Accounts Receivable, External Audit, Leadership, Business Process..., ERP, Executive Management, Analysis
Education
Nichols College 1999 — 2002
Masters, Business Administration
Fitchburg State University 1994 — 1998
Bachelors, Business Administration
Leominster High
University of Louisville Physicians-UCSA. August 2013 - Present
HEME Management 2010 - June 2013
EVAHEART-Medical January 2010 - May 2013
HeartWare Inc January 2008 - January 2010
Thoratec June 2005 - January 2010
United Extracorporeal Support Inc June 1995 - January 2010
Clarian Health Partners June 1989 - June 1995
Skills
Ventricular Assist..., Medical Devices, Cardiovascular..., Circulation technology, Surgery, Biomedical Engineering, Heart Failure, Clinical Trials, Lifesciences, Clinical Research, Critical Care, Healthcare, ECMO, Transplant, Nursing, IABP, Cardiology, Perfusion, Cardiac Surgery, Interventional..., ICU, Cardiopulmonary, Cardiothoracic Surgery, Operating Room, Medicine, Hospitals, Life Sciences
Education
The Ohio State University/Cleveland Clinic Fnd. School of Cardiovascular Perfusion 1993 — 1995
Certificate, Circulation Technology
Butler University 1984 — 1988
BS, Pre-Med/Biology
Device Technology Consultant July 2009 - Present
Device Technology Consultant LLc July 1999 - Present
Device Technology Consultant LLc August 2007 - December 2009
HeartWare Inc July 2007 - May 2009
Johnson & Johnson July 1996 - July 2007
Cordis June 1992 - July 1996
Alison Plating Corporation August 1988 - July 1992
Dow Chemical July 1980 - July 1988
Colgate Palmolive July 1974 - July 1980
Education
City University of New York 1972 — 1974
BS, Electro-mechanical Engineering
Voorhees technical Institute 1970 — 1972
AA, tool & Die Making
Universidad Nacional de la Plata, Argentina 1965 — 1969
BA, Mechanical Engineering
HeartWare Inc March 2013 - Present
Bay Compuer Associates November 2011 - December 2012
Cytonome, LLC November 2005 - August 2011
CytonomeST LLC November 2005 - August 2011
PointCare Technologies September 2003 - November 2005
Medicept Inc. 2001 - 2003
Harvard Apparatus November 1997 - September 2001
Ethicon Endo-Surgery May 1995 - November 1997
UltraCision 1989 - 1995
Haemonetics 1989 - 1990
Skills
C++, Embedded Systems, cGMP/ISO design process..., Motorola (68HC11)..., Intel (8051) Assembly..., RTOS develompemt..., Cern/ROOT graphics and..., motor and sensor..., VBScript, PLD design, PID design and tuning, Carnegie Mellon SEI,..., Subversion, Codesonar, Trac, UL/CE testing, ANSI C, Multivariate Analysis, Medical
Education
Boston University 1990 — 1995
BS, Computer Science
LSI gate array design training
Heartware Inc. January 2008 - Present
Cordis Corporation, a Johnson & Johnson Company 1992 - Present
Johnson & Johnson 1992 - Present
Johnson & Johnson - Cordis Division March 1992 - October 2007
Cordis Corporation 1992 - 2007
Eastern Air Lines October 1976 - March 1989
Education
Broward College 1989 — 1993
Florida Power & Light June 2007 - March 2011
HeartWare Inc August 2006 - June 2007
VeinRx January 2006 - June 2006
Johnson & Johnson September 2005 - December 2005
Johnson & Johnson June 2005 - December 2005
Cordis May 2004 - September 2005
Cordis January 2002 - July 2004
Cordis May 2001 - December 2001
Education
Florida International University 1997 — 2003
BS, Mechanical Engineering
Oxford Global Resources July 2013 - February 2014
Oxford Global Resources April 2012 - June 2013
Oxford Global Resources May 2010 - November 2011
HeartWare Inc 2010 - 2011
Cordis, a Johnson & Johnson Company June 1998 - December 2008
Skills
Design Control, Manufacturing, Medical Devices, ISO 13485, FDA, Manufacturing..., Validation, V&V, Biomedical Engineering, Kaizen, Lean Manufacturing, Six Sigma, Root Cause Analysis, Design for Manufacturing, Injection Molding, Quality System, FMEA, SPC, Value Stream Mapping, R&D, Product Development, Catheters, GMP, DMAIC, Minitab, Project Management, ISO 14971, Design of Experiments, CAPA, Product Design, Testing, ISO, Process Simulation, Change Control, Design Controls, Simulation
Education
Florida International University 2004 — 2006
Master of Science (MSc), Engineering Management, Systems Engineering
Universidad de La Habana 1973 — 1975
Bachelor of Science (BSc), Mechanical Engineering, Machine Design and Technology
Saint Petersburg State Polytechnical University 1969 — 1973
Bachelor of Science (BSc), Metallurgical Engineering, Metallurgy-Metal Forming and Heat Treatment
Edwards Lifesciences March 2015 - July 2015
Edwards Lifesciences October 2013 - March 2015
Edwards Lifesciences January 2013 - September 2013
Edwards Lifesciences March 2011 - December 2012
Edwards Lifesciences March 2010 - March 2011
HeartWare Inc October 2009 - February 2010
Cordis Corporation, a Johnson and Johnson Company 2006 - 2008
Cordis Corporation, a Johnson and Johnson Company 2002 - 2006
Cordis Corporation, a Johnson and Johnson Company 2000 - 2002
Cordis Corporation, a Johnson and Johnson Company 1996 - 2000
Skills
Materials Science, Visio, PMP, SAP, Polymers, Validation, Design Control, Design of Experiments, Minitab, Quality Auditing, Technology Transfer, Engineering Management, Project Management, Packaging, ISO 13485, Medical Devices, V&V, CAPA, R&D, Six Sigma, FMEA, DMAIC, Manufacturing, Lean Manufacturing, Cross-functional Team..., Manufacturing..., Process Engineering, Process Excellence, Black Belt, Value Stream Mapping, Engineering, 21 CFR Part 11, Quality System, ISO, Quality Assurance, Root Cause Analysis, GMP, FDA, Continuous Improvement, Biomedical Engineering, Quality Control, Testing, Process Simulation, SPC, Product Development, Commercialization, ISO 14971, Change Control, Quality Management, Design for Manufacturing
Education
Florida International University 1977 — 1980
BA, Psychology: course study related to industry and human behavior
Miami Dade College 1974 — 1976
AA, General Education: major courses included Physics, Chemistry, Materials of Industry, Social Science
Penn State University 1970 — 1972
Mechanical Engineering
Industrial Management Institute 1966 — 1968
Tool Design, Tool Design, Strength of Materials, Motion & Time Study, Mathematics, Physics
HeartWare Inc December 2014 - Present
Allergan Medical September 2013 - November 2014
Boston Scientific Corporation October 2007 - September 2013
Boston Scientific May 2004 - September 2007
Boston Scientific Corporation 2000 - 2002
Boston Scientific Corporation 1997 - 2002
Resource Applications, Inc. 1992 - 1994
Skills
Statistics, DOE, DMAIC, Manufacturing, Continuous Improvement, Design of Experiments, Minitab, SPC, FDA, Process Improvement, Problem Solving, Data Analysis, Quality Engineering, Medical Devices, CAPA, Design Control, Quality Systems, Validation, Root Cause Analysis, Data Mining, Reliability, ISO 13485, Quality System, Process Simulation, R&D, ISO 14971, Six Sigma, Quality Control
Education
The Pennsylvania State University 2011 — 2016
Master's of Applied Statistics, Applied Statistics
Colby College 1987 — 1991
BA, Biology/Biological Sciences, General
HeartWare Inc March 2013 - Present
HeartWare Inc September 2011 - March 2013
SynCardia Systems, Inc. January 2008 - September 2011
University of California, Irvine May 2003 - June 2007
International Beauty Design, Inc. August 2001 - February 2003
International Beauty Design, Inc. August 2000 - August 2001
Skills
Clinical Research, Cardiovascular Disease, Diabetes, Hospitals, Research, Medical Devices, Medical Education, Operating Room, Cardiology, FDA, Interventional..., Small Business, Entrepreneurship, Cross-functional Team..., Quality System, Clinical Trials, Knowledge Transfer, Analysis, Mechanical Circulatory..., Surgery, Medicine
Education
Harvard Medical School 1999 — 2000
Postdoctoral Fellow
University of Arizona 1995 — 1999
Ph.D.
University of Arizona 1993 — 1995
M.S.
California State University-Long Beach 1987 — 1993
B.S.
HeartWare Inc April 2015 - Present
Nickel Household Inc. July 2008 - March 2015
St. Joseph Health System October 2007 - June 2008
Tellabs, Inc. (formerly Advanced Fibre Communications) 2005 - 2006
Advanced Fibre Communications May 2000 - October 2005
iOwn, Inc 1999 - 2000
Fireman's Fund Insurance Company December 1995 - June 1999
Skills
Benefits Administration, Human Resources, HRIS, Employee Relations, Onboarding, Employee Benefits, Deferred Compensation, Training, Applicant Tracking..., Talent Acquisition, Talent Management, PeopleSoft, Succession Planning, College Recruiting, Employee Engagement, Team Building
Education
Sonoma State University 1993 — 1995
Political Science
California State University-Long Beach
Stryker March 2015 - Present
HeartWare Inc March 2014 - March 2015
Stryker Neurovascular January 2013 - March 2014
Stryker Neurovascular April 2011 - December 2012
Boston Scientific/Stryker August 2005 - April 2011
Boston Scientific January 2001 - August 2005
Skills
Product Launch, Medical Devices, Sales Operations, Integration, Cross-functional Team..., Supply Chain, Finance, Customer Service, Sales, Capital Equipment, Neurology, Management, Sales Effectiveness, Product Development, Cardiology, Market Development, Operating Room, Surgeons
Education
Boston College - Wallace E. Carroll Graduate School of Management 2000 — 2005
MBA, Management
Bentley University 1993 — 1997
HeartWare Inc July 2012 - Present
LabCorp December 2010 - June 2012
Genzyme September 2004 - November 2010
Harvard University 2003 - August 2005
Education
Northeastern University - Graduate School of Business Administration
MBA
Simmons College 1994 — 1998
BA, Economics & Sociology
Falmouth High School
Falmouth High School
Nipro Diabetes Systems December 2005 - Present
HeartWare Inc December 2002 - November 2005
Cordis/Johnson & Johnson 1983 - 2002
Education
Barry University
Miami Dade College
HeartWare Inc December 2014 - Present
Philips Healthcare August 1996 - November 2014
Bell+Howell PSC March 1993 - August 1996
Gould Electronics July 1992 - March 1993
Skills
Medical Devices, FDA, CAPA, Regulatory Affairs, QSR, Quality Systems, Complaints Management, Design Control, Clinical Validation, Complaint Management, Biomedical Engineering, Teamwork, Engineering, Quality System, Six Sigma, Integration, Product Development, Manufacturing, Testing, Process Improvement, Cross-functional Team..., Validation, ISO 13485, Project Management, Management, Lean Manufacturing
Education
Case Western Reserve University 1993 — 1996
MSCE/MBA, Engineering
HeartWare Inc May 2012 - Present
HeartWare Inc July 2010 - May 2012
HeartWare Inc June 2005 - July 2010
Boston Scientific 2000 - 2005
Skills
Design Control, ISO 13485, V&V, Gage R&R, CAPA, Medical Devices, Design of Experiments, Process Capability, FDA, Measurement System..., Minitab, Design for Manufacturing, Validation, Control Charts, FMEA, SPC, Quality System, GD&T
Education
Florida International University 2000 — 2006
Bachelor's degree, Industrial Engineering
Cirle February 2014 - Present
Q’STRAINT August 2012 - February 2014
CYCLONE POWER October 2011 - August 2012
Syntheon LLC May 2009 - April 2010
Nipro Diabetes Systems September 2005 - October 2008
HeartWare Inc November 2002 - September 2005
Cordis/Johnson & Johnson 1983 - October 2002
Skills
ISO 13485, Design Control, Medical Devices, FDA, V&V, Validation, CAPA, Complaint Management, Product Development, Quality System, Product Launch, R&D, Manufacturing..., Product Design, GD&T, Design of Experiments, Design for Manufacturing, Injection Molding, Biomedical Engineering, Manufacturing, Quality Control, Minitab, Solidworks, Capital Equipment, DMAIC, Engineering, ISO 14971, FMEA, Orthopedic, Lean Manufacturing, SPC, Cross-functional Team..., ISO, GMP, Catheters, Commercialization, Six Sigma, Quality Assurance, Root Cause Analysis, Machining, Gage R&R, Plastics, Mechanical Engineering, Failure Analysis, Process Simulation, Testing, Engineering Management, Continuous Improvement, Project Management, Process Improvement
Education
Barry University
Bachelor of Science (BS), Professional Administration & Minor Information Technology
Miami Dade College
Associate's degree, Industrial Electronics
University of Miami
Bachelor’s Degree, Mechanical Engineering 60% complete
HeartWare Inc. January 2012 - Present
Kerzner International September 2008 - December 2012
The RAM Group April 2007 - July 2008
Skills
Accounting, General Ledger, Microsoft Office, Accounts Payable, Budgets, Financial Reporting, Account Reconciliation, Accounts Receivable, US GAAP, Auditing, Microsoft Word, Corporate Finance, Financial Analysis, Sarbanes-Oxley Act, PeopleSoft, Fixed Assets, Finance, Internal Controls, Forecasting, Financial Modeling, Cash Flow, Customer Service, Inventory Management
Education
Nova Southeastern University 2008 — 2009
MBA, Business
Nova Southeastern University 2008 — 2009
MBA, Business
Florida International University 1998 — 2000
Bachelor's Degree, International Business and Marketing
HeartWare Inc May 2002 - Present
HeartWare, Inc. Miami/Fort Lauderdale Area 2002 - Present
Honeywell Aerospace 1976 - 1999
Honeywell Aerospace 1976 - 1999
Skills
ISO 13485, FDA, Root Cause Analysis, Product Development, Manufacturing, Medical Devices, Design Control, Design of Experiments, CAPA, Validation, Minitab, Design for Manufacturing, Six Sigma, V&V, Quality System
Education
Broward College
HeartWare Inc July 2013 - Present
St Jude Medical April 2006 - Present
St. Jude Medical April 2002 - April 2006
Bristol-Myers Squibb August 1997 - April 2002
Washington Township Schools August 1996 - July 1997
Skills
Medical Devices, Cardiology, Surgeons, Capital Equipment, Interventional Radiology, Vascular, Disposables, Vascular Surgery, Medical Sales, Sales Operations, Cardiac Surgery, Capital Equipment Sales, Medicine, Pharmaceutical Sales, Operating Room, Selling Skills, Sales, Cath Lab, Catheters, Urology, Selling, Market Development
Education
Texas A&M University-Commerce 2012 — 2013
Master of Business Administration (MBA)
Southern Methodist University 2009 — 2009
Graduate Certificate- Fundamentals of Corporate Finance
Ball State University 1991 — 1996
B.S., Elementary Education
HeartWare, Inc June 2010 - Present
Boston Scientific March 2008 - June 2010
University of Miami September 2005 - January 2007
Bernstein and Maryanoff June 2004 - August 2005
Skills
Design Control, Biomedical Engineering, Medical Devices, FDA, V&V, Minitab, CAPA, Validation, Quality System, Quality Assurance, Solidworks, Statistics, Software Documentation, Testing, Cross-functional Team...
Education
University of Miami 2005 — 2008
BS, Biomedical Engineering
Florida International University 2002 — 2004
HeartWare Inc July 2014 - Present
MEDCOMP/MARTECH/POINT medical November 2011 - July 2014
MEDCOMP/MARTECH/POINT medical July 2010 - November 2011
MEDCOMP/MARTECH/POINT medical July 2009 - July 2010
MEDCOMP/MARTECH/POINT medical July 2005 - July 2009
Skills
Solidworks, Pro Engineer, Mechanical Engineering, Finite Element Analysis, Design for Manufacturing, GD&T, Project Engineering, Engineering, Design Control, Machine Design, Injection Molding, Engineering Management, FMEA, Manufacturing..., Medical Devices, ISO 13485, Design History, Manufacturing, ISO 14971, FDA, Quality System, Minitab, R&D, SolidWorks
Education
Duke University 1999 — 2005
BS, Mechanical Engineering
Lehigh University 1999 — 1999
InVivo Therapeutics August 2013 - Present
Taris Biomedical July 2010 - July 2013
ConforMIS, Inc. May 2009 - July 2010
HeartWare Inc August 2008 - April 2009
Boston Scientific October 2004 - August 2008
Vertex Pharmaceuticals March 2003 - October 2004
PAREXEL November 1997 - February 2003
Skills
Clinical Trials, Clinical Data Management, Trial Management, Clinical Operations, FDA, Medical Devices, Biotechnology, Clinical Development, Pharmaceutical Industry, Quality Assurance, GCP
Education
Boston University 1988 — 2000
MS, Biomedical Engineering
University of Massachusetts, Amherst 1984 — 1988
BS, Electrical Engineering
Zumba February 2015 - Present
HeartWare Inc February 2013 - January 2015
Amcor Rigid Plastics September 2011 - February 2013
Citrix Systems November 2006 - September 2011
GKR, LLC April 2003 - July 2006
Skills
Sarbanes-Oxley Act, US GAAP, Consolidation, Hyperion Enterprise, Internal Controls, Financial Reporting, Payroll, Variance Analysis, Financial Accounting, General Ledger, Financial Analysis, Accounting, Auditing, Forecasting, Sarbanes-Oxley, GAAP, Finance
Education
Florida Atlantic University 2008 — 2010
Bachelor's Degree, Finance
Florida Atlantic University 2001 — 2003
BS, Accounting
AIDS Healthcare Foundation August 2014 - Present
HeartWare Inc September 2013 - August 2014
AHF/ Positive Healthcare November 2010 - August 2013
Noven Pharmaceuticals December 2004 - October 2010
US Navy July 1978 - October 2006
Schering-Plough January 2004 - December 2004
OPM Health Consulting, Inc. May 1998 - December 2003
GE Aviation May 1998 - December 2001
Skills
Healthcare, Hospitals, Occupational Health, Infection Control, Infectious Diseases, Safety, Community Health, Military Medicine, Disability Management, Workers' Compensation..., Health and Wellness, Medical Case Management, Drug Free Workplace, Preventive Medicine, Six Sigma, Cross-functional Team..., Pharmaceutical Industry, Healthcare Management, Healthcare Consulting, Nursing, Process Improvement, Clinical Research, Oncology, FDA, Medical Devices, Informatics, Patient Advocacy, Medicine, Leadership, Training
Education
Nova Southeastern University 2007 — 2009
M.S., Organizational Leadership
Barry University 1991 — 1992
B.S., Nursing
Florida International University 1985 — 1987
B.A., Psychology
Miami Senior High
HeartWare Inc September 2006 - Present
Boston Scientific 2005 - 2006
Boston Scientific 2000 - 2005
Education
Northeastern University - Graduate School of Business Administration 1997 — 1998
Master of Business Administration (MBA)
Lafayette College 1982 — 1986
BA, Economics
HeartWare Inc November 2011 - Present
HeartWare Inc October 2010 - October 2011
Cordis Corporation August 2005 - October 2010
Cordis Corporation August 2001 - August 2005
Skills
Packaging, Medical Devices, FDA, Continuous Improvement, Cardiology, Regulatory Affairs
Education
Florida Atlantic University 2004 — 2006
Master, Business Administration
HeartWare Inc January 2015 - Present
Vittum Financial Group February 2004 - Present
Euro-Pro September 2010 - January 2015
Suffolk Construction July 2007 - 2010
Monitor Company Group LP 2004 - 2007
McGladrey & Pullen 1999 - 2004
Ernst & Young 1998 - 1999
Skills
Management Consulting, Financial Reporting, Manufacturing, Financial Analysis, Accounting, Tax Research, Tax, Microsoft Word, Auditing, Internal Controls, Strategy, Business Strategy, Start-ups, Financial Accounting, Mergers & Acquisitions, Forecasting, Sarbanes-Oxley Act, GAAP, US GAAP, CPA, Strategic Planning, Budgets, Due Diligence, SEC filings, Internal Audit, Financial Modeling, Process Improvement, Analysis, Business Planning, Restructuring, Strategic Financial..., Tax Accounting
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1997 — 1998
Master, Personal Financial Planning
Bentley University 1993 — 1997
BS, Accounting
HeartWare Inc April 2008 - Present
HeartWare Inc October 2005 - April 2008
HeartWare Inc May 2002 - October 2005
Compaq Computer Corporation 2000 - 2001
Compaq Computer Corporation (Microcom subsidiary) 1997 - 2000
Compaq Computer Corporation (Microcom subsidiary) 1994 - 1997
Compaq Computer Corporation (Microcom subsidiary) 1993 - 1994
Skills
Design Control, Product Launch, Medical Devices, ISO 13485, Project Management, FDA, Product Management, Business Strategy, Biomedical Engineering, Marketing Strategy, Cross-functional Team..., Product Development, Commercialization, Market Development, Quality System, Engineering, R&D, Manufacturing
Education
FLORIDA INTERNATIONAL UNIVERSITY, CHAPMAN GRADUATE SCHOOL OF BUISINESS 2003 — 2006
Master of Business Administration (MBA), International Business
BOSTON UNIVERSITY, COLLEGE OF ENGINEERING 1988 — 1992
Bachelor of Science (B.S.), Electrical Engineering
Kings College
AlterG June 2014 - Present
DRC Contract Quality Assurance Specialist July 2012 - Present
Maquet Getinge Group January 2014 - April 2014
Johnson & Johnson April 2013 - October 2013
HeartWare Inc October 2011 - April 2013
Maetrics, LLC 2013 - 2013
Maetrics, LLC 2013 - 2013
Oxford Global Resources October 2011 - May 2012
Screen-Tech, Inc May 2010 - March 2011
Fantastic Fan Filters LLC 2009 - 2011
Skills
Certified Quality..., Six Sigma, ISO 13485, CAPA, Engineering Change..., Change Control Board, ISO 9000, Supplier Risk Management, Supplier Quality..., Supplier Evaluation, Supplier Performance, Iso 9000, CQA, DMAIC, Electronics, SPC, Manufacturing, Engineering, Design of Experiments, Quality Control, Quality Assurance, Supplier Quality
Education
San Jose State University 2001 — 2003
MS, Quality Assurance
California State University-Chico 1988 — 1992
BS, Electronic & Computer Technology
HeartWare Inc Sr. PlannerBolton Medical2004 - 2006
Medtronic 2001 - 2002
Skills
Medical Devices, CAPA, Forecasting, Supply Chain, Materials Management, Manufacturing, ISO 13485, Purchasing, Quality System, Continuous Improvement, FDA, Six Sigma, ISO, Cross-functional Team..., Validation, Design Control
Education
Florida International University 2000 — 2004
Bachelor of Business Administration (B.B.A.), Business Administration, Management and Operations
HeartWare Inc February 2014 - Present
HeartWare Inc January 2013 - February 2014
HeartWare Inc 2011 - 2013
HeartWare Inc 2010 - 2011
Boston Scientific October 2007 - January 2010
HeartWare Inc 2010 - 2010
Boston Scientific September 2006 - October 2007
Boston Scientific July 2005 - May 2007
Gillette June 2004 - August 2004
Fortis Insurance Belgium November 1999 - June 2003
Skills
Product Development, Cardiac, Cardiology, Product Marketing, Healthcare, Product Management, Product Strategy, Medical Devices, Marketing Strategy, Cross-functional Team..., Market Development, Product Launch, Commercialization, Strategic Planning, New Business Development, Competitive Analysis
Education
Dartmouth College - The Tuck School of Business at Dartmouth 2003 — 2005
MBA, General Management
Bowdoin College 1993 — 1997
BA, Government and Legal Studies; Economics
St. Paul's School 1990 — 1993
High School
Blake School 1989 — 1990
Warren Henry Automotive Group February 2015 - Present
HeartWare Inc September 2014 - February 2015
Harley-Davidson Motor Company April 2012 - September 2014
Bupa Worldwide Corporation November 2009 - March 2012
Carnival Cruise Lines February 1990 - March 2009
Skills
Employee Benefits, Human Resources, FMLA, Exit Interviews, Benefits Administration, Employee Relations, Temporary Placement, HRIS, Kronos, Management, SAP HR, HR Policies, Talent Acquisition, Payroll, Policy, Time Management, Employee Engagement, Performance Management, ADP HRB, ADP Payroll, Administration, Recruiting, Administrative..., Applicant Tracking..., Workforce Planning, System Administration, Onboarding
Education
DeVry University 2010 — 2012
Bachelor's Degree, Human Resources Management
Miami Dade College 2010 — 2010
Human Resources Professional Certificate
Miami Dade College 1987 — 1991
Associate of Science (AS), Travel & Tourism Industry Management
HeartWare Inc April 2012 - Present
HeartWare Inc. October 2011 - April 2012
HeartWare Inc October 2007 - October 2011
SCION CARDIO-VASCULAR, INC January 2001 - October 2007
Cordis Corp October 1995 - October 2001
THERATEK INTERNATIONAL, INC 1988 - 1995
General Electric Aircraft Engine Business Group - Lynn MA July 1984 - January 1988
Skills
Manufacturing, Product Development, Engineering, V&V, Medical Devices, Design Control, ISO 13485, FDA, ISO 14971, CAPA, Quality Assurance, Quality System, QA Engineering, FMEA, Design of Experiments, Validation, Design for Manufacturing, Biomedical Engineering, ISO, Minitab, R&D, GMP, Root Cause Analysis, Manufacturing..., Process Simulation, SPC, Lean Manufacturing, Change Control, Six Sigma, Quality Auditing, FDA GMP, Cross-functional Team..., Supplier Quality, Quality Management, Process Engineering, Project Management, Product Engineering
Education
Boston University 1980 — 1984
BS, ME
HeartWare Inc PlannerIVAX2002 - 2004
Skills
FDA
Education
Florida International University 2000 — 2004
Bachelor, International Business
HeartWare Inc 2010 - Present
Bausch & Lomb 2004 - 2009
Baxter Healthcare 2000 - 2003
Althin Medical 1997 - 2000
Skills
Lean Manufacturing, CAPA, V&V, ISO 13485, Medical Devices, Quality System, R&D, Validation, Design for Manufacturing, Design of Experiments, Design Control, Root Cause Analysis, FDA, Manufacturing, Biomedical Engineering, Product Development
Education
Florida International University
BS, Mechanical Engineering
HeartWare Inc September 2014 - Present
iGATE April 2011 - Present
Manas Microsystems Private Limited March 2008 - April 2011
Skills
C, Embedded Systems, Requirements Analysis, Embedded C, Project Planning, Analog Circuit Design, Digital Circuit Design, Emissions Control, Medical Devices, industrial..., Automation, SPI, I2C, I2S, LabVIEW, RS232, RS485, Modbus, USB, GSM, Signal Integrity, FPGA, Microcontrollers, Audio Amplifiers, Audio Codecs, Battery Management..., RoHS
Education
Genba Sopanrao Moze College Of Engineering 2003 — 2007
Bachelor's Degree, Electrical, Electronics and Communications Engineering
HeartWare Inc May 2013 - Present
Ageless Institute November 2011 - May 2013
Ageless Regenerative Institute May 2011 - May 2013
Bio-Tissue Inc. November 2010 - February 2011
Beckman Coulter 2010 - 2011
Bioheart Inc April 2010 - September 2010
Florida International University June 2009 - August 2010
Florida International University September 2008 - May 2009
Skills
Western Blotting, Spanish, Protein Chemistry, Microsoft Office, Cell, Stem Cells, Manufacturing, Cell Culture, Matlab, GMP, Research, cGMP practices, ISO 13485
Education
Florida International University 2006 — 2011
Florida International University 2006 — 2011
Bachelor of Science, Biomedical Engineering
HeartWare Inc October 2014 - Present
Cubist Pharmaceuticals October 2013 - September 2014
New England Research Institutes, Inc. (NERI) June 2012 - May 2013
Biostatistics department in University of Massachusetts, Amherst, MA, USA September 2011 - June 2012
Population Health and Health Disparities (CPHHD) in Northeastern University, Boston, MA, USA May 2011 - June 2012
Department of Pediatrics and Neurobiology Duke University School of Medicine, Durham, USA August 2009 - August 2010
Skills
Biostatistics, Survival Analysis, Bioinformatics, Epidemiology, Microsoft Excel, R, SAS, Data Analysis, Statistics, SAS Programming, Clinical Research, CRO, Pharmaceutical Industry, Clinical Trials, Protocol, SOP
Education
University of Massachusetts Amherst, MA 2010 — 2012
Master of Science (MS), Biostatistics
Central South University 2001 — 2004
Master of Science (MS), Cardiovascular Pharmacology
Xiangya Medical School, Central South University 1995 — 2000
Doctor of Medicine (MD), Clinic Medicine
HeartWare Inc 2015 - Present
HeartWare Inc 2013 - 2015
NxStage Medical 2013 - 2013
Wyss Institute for Biologically Inspired Engineering 2011 - 2012
Boston University 2010 - 2011
Skills
Medical Devices, Biomedical Engineering, Matlab, Biotechnology, FDA, Data Analysis, Life Sciences, SolidWorks, Cross-functional Team..., Product Development
Education
Boston University
BS, Biomedical Engineering
HeartWare Inc July 2014 - Present
UMass Boston August 2011 - July 2014
East Boston Montessori School January 2009 - June 2014
Golden Mittens Montessori January 2008 - December 2008
Infinity Retail Services January 2007 - June 2007
Skills
Editing, Creative Writing, Research, Microsoft Office, Public Speaking, Copy Editing, Facebook, Proofreading, Customer Service, Oral & Written..., Outstanding..., Clerical Skills, Organization, Comfortable working..., Teamwork, Bilingual-English/Spanis..., Superior Work Ethic, Grasp New Concepts..., Analytical Skills, Eager to learn new...
Education
University of Massachusetts Boston 2009 — 2014
Bachelor's Degree, Psychology & English Literature
Florida International University 2007 — 2008
Undergraduate Studies
HeartWare Inc April 2015 - Present
Hollander Home Fashions, LLC February 2012 - April 2015
Flexsol packaging May 2007 - March 2012
Cordis December 2000 - May 2007
Xcellerate 1997 - 2000
Alamo 1994 - 1997
Education
Florida International University 1983 — 1988
BBA, Accounting
HeartWare Inc February 2011 - March 2015
QRCC Consulting March 2009 - August 2012
Nautilus Water Co. Ltd. 2008 - 2009
Swiss Caps USA 2006 - 2007
Watson Pharmaceuticals (formerly Andrx Pharmaceuticals) 2002 - 2006
Centers for Disease Control, National Center for Environmental Health 2002 - 2002
Centers for Disease Control, National Center for Environmental Health 2001 - 2001
Skills
USP, Training, LIMS, CAPA, FDA GMP, Root Cause Analysis, CQA, ISO 13485, Lifesciences, Quality Assurance, Validation, Quality Auditing, Quality Control, Change Control, Medical Devices, GxP, GMP, Regulatory Affairs, 21 CFR Part 11, Quality System, HPLC, GCP, Sop, Quality Management, Document Management, GAMP, R&D, Clinical Development, Aseptic Processing, Analytical Chemistry, Cross-functional Team..., 21 CFR, Pharmaceutics, V&V, Raw Materials, Manufacturing, ISO, Process Improvement, Software Documentation, Design Control, Laboratory, Regulatory Requirements, Biotechnology, Deviations, Pharmaceutical Industry, Regulatory Submissions, Chromatography, Trackwise, FDA, Biopharmaceuticals
Education
The National Graduate School of Quality Management (NGS) 2013 — 2014
Master's Degree
Florida Memorial University 1998 — 2001
Bachelor of Science Degree
Akademia Medyczna w Warszawie
HeartWare Inc March 2011 - Present
G6 Productions LLC May 2010 - Present
HeartWare Inc October 2010 - March 2011
Skills
Biomedical Engineering, Medical Devices, Solidworks, Design Verification..., Product Development, Validation, GMP, Engineering, Labview, GD&T, Matlab, Microsoft Office, Testing
Education
Florida International University 2006 — 2010
B.S., Biomedical engineering
HeartWare Inc October 2010 - Present
HeartWare Inc May 2009 - October 2010
Skills
Design Control, Medical Devices, CAPA, Quality System, FDA, FMEA, Quality Assurance, Validation, Biomedical Engineering, Testing, Solidworks, CAD/CAM, ISO 14971, SolidWorks, V&V
Education
Broward Community College 2013 — 2016
BSN/MSN/CRNA, Registered Nursing/Registered Nurse
Central Florida Fire Academy 2006 — 2008
Fire-Fighter/EMT Certification, Fire Science/Paramedics
Florida Universal Technical Institute 2003 — 2005
Electronics and Mechanical Certification, Engine Electronics/Mechanical Design
Phiston Technologies May 2013 - April 2014
Beckman Coulter June 2012 - May 2013
HeartWare Inc January 2012 - June 2012
TUUCI November 2009 - January 2012
Northrop Grumman Corporation April 2008 - November 2009
EMTEQ January 2008 - April 2008
Protective Materials Group July 2006 - January 2008
Boston Scientific June 1996 - July 2006
Americ Disc June 1991 - June 1996
U.S Airforce August 1989 - August 1991
Skills
Design for Manufacturing, Solid Modeling, Solidworks, Product Design, GD&T, Sheet Metal, Medical Devices, CAD, Manufacturing, Pro Engineer, Product Development, Tolerance Analysis, Mechanical Engineering, Machining, Design of Experiments, Rapid Prototyping, Machine Design, Manufacturing..., AutoCAD, Finite Element Analysis, FDA, FMEA, Troubleshooting, Engineering Design, Design Control, Engineering, Geometric Dimensioning, Injection Molding, Lean Manufacturing, Machine Tools, Materials, PDM, SolidWorks, Testing, Geometric Dimensioning...
Education
Florida International University 1990 — 1993
Bachelor of Science (BS), Mechanical Engineering
Miami Dade College 1988 — 1990
Associate of Arts (A.A.)
Miami Jackson Senior High 1980 — 1984
Diploma, General
HeartWare Inc February 2014 - Present
Boston University August 2008 - January 2014
Education
Boston University
PhD, Mechanical Engineering
Boston University
2008M.S, Biomedical Engineering
Harvey Mudd College
2005B.A, General Engineering
Terumo Cardiovascular Systems January 2015 - Present
Terumo Cardiovascular Systems May 2014 - December 2014
HeartWare Inc March 2014 - May 2014
UMTB Biomedical Inc. October 2013 - January 2014
Biomet 3i October 2013 - October 2013
University of Miami Brain Endowment Bank October 2013 - October 2013
Hospira August 2013 - October 2013
Zimmer October 2011 - July 2013
Florida Department of Transportation District 6 January 2010 - October 2011
Florida International University, Department of Chemistry and Biochemistry January 2009 - May 2011
Skills
Validation, Design of Experiments, Design Control, Biomedical Engineering, ISO 13485, FDA, Quality System, V&V, Minitab, Cleaning Validation, Statistics, Quality System..., 21 CFR Part 11, Quality Control, CAPA, Testing, Medical Devices, Labview, R&D, Manufacturing, GMP, Sop, Biomechanics, Solidworks, ISO 14971, FMEA, Cell Culture, SPC, Matlab, Root Cause Analysis, Biotechnology, SOP, LabVIEW
Education
Florida International University
Bachelor of Science, Biomedical Engineering
HeartWare Inc October 2012 - Present
Natures Product's January 2011 - January 2012
BioTissue Inc. January 2007 - June 2009
Noven Pharmaceuticals January 1998 - January 2003
Ivax Pharmaceuticals January 1994 - January 1998
Skills
Pharmaceutical Industry, Project Management, Biotechnology, Clinical Trials, PowerPoint, Microsoft Word, Validation, Change Management, Customer Service, Training, Compliance, FDA, Healthcare, Software Documentation, Quality Assurance, ISO 13485, CAPA, Quality System, Cross-functional Team..., Sop
Education
DeVry University-Florida 2009 — 2013
Bachelor of Business Administration (B.S.), Human Resources Management and Services, 3.75
Philips Health Systems August 2015 - Present
HeartWare Inc June 2014 - August 2014
JoVE April 2012 - June 2013
Genetic Services, Inc. March 2010 - March 2012
BU Culture Shock February 2010 - May 2011
Akmal Inc 2007 - 2009
Brigham and Women's Hospital October 2007 - August 2008
Skills
B2B Marketing Strategy, Market Intelligence, Microsoft Excel, PowerPoint, Online Marketing, Strategy, SPSS, Public Speaking, Blogging, Social Media, Press Releases, Editing, Creative Writing, Microsoft Access, HTML + CSS, Microsoft Office, Web Analytics, Database Management, Wordpress, Research, Data Analysis, Trade Shows, Marketing, Feature Writing, Science Writing, Facebook Advertising, Twitter Advertising, LinkedIn Advertising, Conference Coordination, Trade Show Exhibitor, Trade Show Strategy, Trade Show Presentations, Email Marketing, Genetics, Management, Social Media Marketing
Education
Boston University Graduate School of Management 2013 — 2015
Master of Business Administration (M.B.A.)
Boston University 2007 — 2011
Bachelor of Arts (B.A.)
Sharon High School 2003 — 2007
High School Diploma
Med-Sonics August 2014 - Present
HeartWare Inc January 2009 - January 2010
Beth Israel Deaconess Medical Ctr January 2006 - January 2008
St. Elizabeth’s Medical Center January 1999 - January 2006
Northeastern University January 1995 - January 2005
Beth Israel Deaconess Med Ctr January 1993 - January 1999
Massachusetts General Hospital January 1992 - January 1993
Skills
Microsoft Office, Microsoft Excel, Customer Service, Microsoft Word, PowerPoint, Outlook, Windows, English, Research, Budgets, Strategic Planning, C++, Medical Devices, Clinical Research, Healthcare, Clinical Trials
Education
University of Massachusetts, Amherst 2010 — 2013
Master of Business Administration (MBA), 3.8
Northeastern University
Certificate, Perfusion Technology/Perfusionist
Boston University 1988 — 1991
B.S, Biomedical Engineering
West Virginia University
B.S, Pre-Medical Studies
HeartWare Inc October 2013 - Present
International Consulting Group, Inc March 2011 - September 2013
TigerDirect.com 2009 - 2011
Centro Nacional de Genetíca y Biotecnología February 2006 - January 2009
Skills
Vendor Management, Procurement, Computer Hardware, Six Sigma, Project Management, Inventory Management, Matlab, Product Management, Product Development, VHDL, Testing, Engineering, Labview, Hardware, Process Engineering, Electronics, Lean Manufacturing, Automation, Instrumentation, Multisim, Inventory Control
Education
Florida International University 2012 — 2013
Bachelor of Engineering (B.E.), Electrical and Electronics Engineering
Florida International University 2012 — 2012
Certificate, Six Sigma-Green Belt
Instituto Superior Politécnico Jose A. Echeverria 2004 — 2009
Automation Control Engineer, Engineering/Industrial Management
HeartWare Inc March 2012 - Present
Boston Scientific 2007 - 2012
Skills
Medical Devices, FDA, ISO 13485, CAPA, Quality System, Six Sigma, Process Improvement, Cross-functional Team..., Lean Manufacturing, Continuous Improvement, Quality Assurance, Performance Management, Manufacturing, GMP, Minitab, Root Cause Analysis, Team Building, DMAIC
Education
Seton Hall University 2000 — 2001
Master of Arts (M.A.), Strategic Communication and Leadership
Duquesne University 1992 — 1996
Bachelor of Arts (B.A.), Journalism and Sociology
HeartWare Inc February 2013 - Present
Covidien (Acquired Somanetic's July 2010) October 2005 - February 2013
Somanetics Corporation October 2005 - August 2010
Arrow International March 2004 - October 2005
Cleveland Clinic August 1997 - March 2004
Skills
Cardiac Device Sales, Operating Room, Cardiac Surgery, Vascular, Medical Sales, Surgeons, Disposables, Capital Equipment, Interventional..., Interventional Radiology, Surgical Instruments, Cardiology, Vascular Surgery, Medical Devices, Orthopedic, Urology, Surgery, Market Development, Neurosurgery
Education
Case Western Reserve University
Bachelor of Science (B.S.) Nursing, Registered Nurse
HeartWare Inc March 2015 - Present
HeartWare Inc December 2014 - Present
HeartWare Inc May 2014 - December 2014
HeartWare Inc August 2013 - May 2014
Skills
Minitab, SolidWorks, Clinical Research, Biomedical Engineering, NI LabVIEW, Medical Devices, Microsoft Excel, Microsoft Word, Engineering, Six Sigma, GLP, Matlab, LabVIEW, Microsoft Office, FDA, Microsoft Access
Education
Florida International University 2008 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering