HeartWare Inc

Industry: Company

Description

Headquarters: Framingham, MA Parent organization: Medtronic, Inc. Subsidiaries: HeartWare Inc, HeartWare Ltd

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HeartWare Inc Employees

Employee
Years
Job
Industry
Laura Marconi Laura Marconi Miami/Fort Lauderdale Area Details
Laura Marconi's HeartWare Inc Experience June 2014 - Present
Job QA Compliance Administrator at HeartWare Inc
Industry Medical Devices
Experience
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

Maureen Romagnoli Maureen Romagnoli Manchester, New Hampshire Details
Maureen Romagnoli's HeartWare Inc Experience February 2012 - Present
Job Technical Documentation Consultant at HeartWare Inc
Industry Computer Software
Experience
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)

Kimberly Urgo Kimberly Urgo Philadelphia, Pennsylvania Details
Kimberly Urgo's HeartWare Inc Experience MCSD CoordinatorUniversity of Pennsylvania Health System2009 - 2012
Job Clinical Specialist at HeartWare Inc
Industry Medical Devices
Experience
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

Chelsey Bishop Pjesky Chelsey Bishop Pjesky Greater Chicago Area Details
Chelsey Bishop Pjesky's HeartWare Inc Experience January 2014 - Present
Job North America Midwest Regional Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Lashawnda White Lashawnda White Miami/Fort Lauderdale Area Details
Lashawnda White's HeartWare Inc Experience September 2014 - Present
Job Quality Analyst
Industry Hospital & Health Care
Experience
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

Elena Yaikova Elena Yaikova Miami/Fort Lauderdale Area Details
Elena Yaikova's HeartWare Inc Experience July 2013 - May 2014
Job Staff Accountant at TwinStar International
Industry Accounting
Experience
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

Scott Impola Scott Impola Miami/Fort Lauderdale Area Details
Scott Impola's HeartWare Inc Experience September 2012 - December 2012
Job Optimizing Supply Chains Entrepreneur/Owner At Impola International
Industry International Trade and Development
Experience
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

Guilherme Von Zuben Guilherme Von Zuben Greater Boston Area Details
Guilherme Von Zuben's HeartWare Inc Experience 2012 - 2013
Job Sales Engineer at Olympus IMS
Industry Mechanical or Industrial Engineering
Experience
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

Jim Yearick Jim Yearick Greater Minneapolis-St. Paul Area Details
Jim Yearick's HeartWare Inc Experience August 2014 - Present
Job Vice President, Marketing at HeartWare Inc
Industry Medical Devices
Experience
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

Lisbert Avila-Yu Lisbert Avila-Yu Miami/Fort Lauderdale Area Details
Lisbert Avila-Yu's HeartWare Inc Experience March 2014 - Present
Job Associate Director of Regulatory Affairs at HeartWare Inc.
Industry Medical Devices
Experience
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

Marcel Gonzalez Marcel Gonzalez Fort Lauderdale, Florida Details
Marcel Gonzalez's HeartWare Inc Experience December 2007 - April 2014
Job Principal Technician at Applied MedTech LLC
Industry Medical Devices
Experience
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

Nicolas Norena Nicolas Norena Laurel, Maryland Details
Nicolas Norena's HeartWare Inc Experience May 2012 - August 2012
Job Software Systems Engineer at JHU/APL
Industry Biotechnology
Experience
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

Andre Castillo Andre Castillo Fort Lauderdale, Florida Details
Andre Castillo's HeartWare Inc Experience November 2014 - Present
Job Senior Mechanical Engineer, Advanced Product Development at HeartWare Inc
Industry Medical Devices
Experience
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)

Russell Johnson, EE Russell Johnson, EE Greater Boston Area Details
Russell Johnson, EE's HeartWare Inc Experience May 2013 - Present
Job Manager, Regulatory Affairs at HeartWare Inc
Industry Medical Devices
Experience
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

Jorge Zaldivar, CSCP, SPSM Jorge Zaldivar, CSCP, SPSM Miami/Fort Lauderdale Area Details
Jorge Zaldivar, CSCP, SPSM's HeartWare Inc Experience April 2013 - July 2014
Job Buyer at Actavis plc
Industry Medical Devices
Experience
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

Amanda Clinton Amanda Clinton Greater New York City Area Details
Amanda Clinton's HeartWare Inc Experience May 2011 - August 2011
Job NYU M.S. Global Affairs
Industry International Affairs
Experience
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

Noel Ramirez Noel Ramirez United States Details
Noel Ramirez's HeartWare Inc Experience October 2012 - Present
Job Supervisor New Product Intro at HeartWare Inc
Industry Medical Devices
Experience
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

Heather Harries Heather Harries Miami/Fort Lauderdale Area Details
Heather Harries's HeartWare Inc Experience January 2008 - September 2009
Job Vice President of Quality Assurance at Bolton Medical
Industry Medical Devices
Experience
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

Jonathan Eagle Jonathan Eagle Greater Boston Area Details
Jonathan Eagle's HeartWare Inc Experience April 2011 - Present
Job Principal Electronics Engineer at HeartWare Inc
Industry Medical Devices
Experience
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

Euler Ortega Euler Ortega Miami/Fort Lauderdale Area Details
Euler Ortega's HeartWare Inc Experience January 2011 - June 2013
Job Principal Engineer at Cordis
Industry Medical Devices
Experience
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

Mark Fennell Mark Fennell Greater Boston Area Details
Mark Fennell's HeartWare Inc Experience December 2013 - Present
Job Corporate Counsel at HeartWare Inc
Industry Law Practice
Experience
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

Catlin Steen Catlin Steen Boston, Massachusetts Details
Catlin Steen's HeartWare Inc Experience May 2013 - July 2014
Job Endoscopy Global Sales Training Projects and Events Administrative Assistant at Boston Scientific
Industry Medical Devices
Experience
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

Nicholas Stalford Nicholas Stalford Littleton, Massachusetts Details
Nicholas Stalford's HeartWare Inc Experience May 2015 - Present
Job Marketing Intern at HeartWare Inc
Industry Marketing and Advertising
Experience
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

Delia (Didi) Aquino Delia (Didi) Aquino Miami/Fort Lauderdale Area Details
Delia (Didi) Aquino's HeartWare Inc Experience June 2010 - Present
Job Administrative Assistant at HeartWare Inc
Industry Medical Devices
Experience
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

Juli-Anne Lee Juli-Anne Lee Miami/Fort Lauderdale Area Details
Juli-Anne Lee's HeartWare Inc Experience January 2010 - Present
Job Change Management Analyst at HeartWare Inc
Industry Pharmaceuticals
Experience
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

Jeffrey Kennington Jeffrey Kennington Flagstaff, Arizona Details
Jeffrey Kennington's HeartWare Inc Experience February 2013 - February 2015
Job Automation Engineer at W. L. Gore & Associates
Industry Medical Devices
Experience
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

Jeff Goriss Jeff Goriss Miami/Fort Lauderdale Area Details
Jeff Goriss's HeartWare Inc Experience October 2010 - Present
Job Manager of Financial Reporting at HeartWare Inc
Industry Consumer Services
Experience
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

Robert Park, MBA, PMP, CSM Robert Park, MBA, PMP, CSM Greater Boston Area Details
Robert Park, MBA, PMP, CSM's HeartWare Inc Experience December 2014 - Present
Job
Industry Information Technology and Services
Experience
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

Silvia Natalia Mann (Valencia) Silvia Natalia Mann (Valencia) Miami/Fort Lauderdale Area Details
Silvia Natalia Mann (Valencia)'s HeartWare Inc Experience October 2010 - Present
Job Master Planner at HeartWare Inc
Industry Medical Devices
Experience
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

Larry Spero Larry Spero Raleigh-Durham, North Carolina Area Details
Larry Spero's HeartWare Inc Experience January 2011 - Present
Job Software Architect at RAREdata = Solutions
Industry Information Technology and Services
Experience
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)

Ricardo Santivanez Ricardo Santivanez Key Biscayne, Florida Details
Ricardo Santivanez's HeartWare Inc Experience April 2015 - Present
Job Recent graduate of Florida International University
Industry Medical Devices
Experience
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

Jennifer Ippolito Jennifer Ippolito Miami/Fort Lauderdale Area Details
Jennifer Ippolito's HeartWare Inc Experience May 2015 - Present
Job Senior Project Manager at HeartWare Inc.
Industry Medical Devices
Experience
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

Avernell Bergan Avernell Bergan Miami, Florida Details
Avernell Bergan's HeartWare Inc Experience March 2012 - Present
Job Experienced Procurement and Sales Professional
Industry Medical Devices
Experience
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

Richard Pilcher Richard Pilcher Miami Beach, Florida Details
Richard Pilcher's HeartWare Inc Experience March 2015 - Present
Job Senior IT Project Manager at HeartWare Inc
Industry Information Technology and Services
Experience
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

Michael DeMello Michael DeMello Greater Boston Area Details
Michael DeMello's HeartWare Inc Experience March 2014 - Present
Job Verification and Validation Engineer II at HeartWare Inc
Industry Biotechnology
Experience
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

Michael Boisvert Michael Boisvert Greater Boston Area Details
Michael Boisvert's HeartWare Inc Experience July 2015 - Present
Job Director of Financial Planning and Analysis
Industry Medical Devices
Experience
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

Emmy Meireles Emmy Meireles Miami/Fort Lauderdale Area Details
Emmy Meireles's HeartWare Inc Experience January 2011 - Present
Job Sr. Human Resources Manager at HeartWare Inc
Industry Medical Devices
Experience
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)

Richard Lothian Richard Lothian Hallandale, Florida Details
Richard Lothian's HeartWare Inc Experience February 2012 - Present
Job Sr. Engineering Manager at HeartWare Inc
Industry Medical Devices
Experience
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

William Williamson William Williamson United States Details
William Williamson's HeartWare Inc Experience February 2015 - Present
Job Manufacturing Engineer
Industry Medical Devices
Experience
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.)

Casey Doherty, CPP Casey Doherty, CPP Miami/Fort Lauderdale Area Details
Casey Doherty, CPP's HeartWare Inc Experience August 2013 - Present
Job Sr. Packaging Engineer at HeartWare Inc
Industry Medical Devices
Experience
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

Ilsa Webeck Ilsa Webeck Greater Boston Area Details
Ilsa Webeck's HeartWare Inc Experience September 2013 - November 2014
Job Principal at MedTech Strategies/ Luminis Partners
Industry Medical Devices
Experience
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

Holly Ann Baldwin Holly Ann Baldwin Greater New York City Area Details
Holly Ann Baldwin's HeartWare Inc Experience August 2010 - Present
Job Training, Learning & Development Manager
Industry Medical Devices
Experience
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

JOAN ROJAS JOAN ROJAS Miami/Fort Lauderdale Area Details
JOAN ROJAS's HeartWare Inc Experience May 2013 - Present
Job CAPA Project Lead II at HeartWare Inc
Industry Medical Devices
Experience
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

Lori Almand Lori Almand Portland, Oregon Area Details
Lori Almand's HeartWare Inc Experience February 2011 - Present
Job U.S. Director, Market Access, Government Policy and Health Outcomes at HeartWare Inc
Industry Hospital & Health Care
Experience
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

Cynthia Feldmann Cynthia Feldmann Greater Boston Area Details
Cynthia Feldmann's HeartWare Inc Experience February 2012 - Present
Job Independent Board Member
Industry Hospital & Health Care
Experience
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

Dan Kritzer Dan Kritzer Miami/Fort Lauderdale Area Details
Dan Kritzer's HeartWare Inc Experience January 2015 - June 2015
Job Integration Engineer at Epic
Industry Medical Devices
Experience
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

Christina McGuire Christina McGuire Tampa/St. Petersburg, Florida Area Details
Christina McGuire's HeartWare Inc Experience March 2011 - March 2012
Job Principal Post Market Surveillance Specialist
Industry Medical Devices
Experience
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

Sue Rose Sue Rose Miami/Fort Lauderdale Area Details
Sue Rose's HeartWare Inc Experience September 2015 - Present
Job At HeartWare Inc
Industry Medical Devices
Experience
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

Eric Nielson Eric Nielson Greater Salt Lake City Area Details
Eric Nielson's HeartWare Inc Experience 2011 - 2011
Job Associate Patent Attorney at Van Cott, Bagley, Cornwall & McCarthy, P.C.
Industry Law Practice
Experience
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

Ravi Atmakuru MBA Ravi Atmakuru MBA Miami/Fort Lauderdale Area Details
Ravi Atmakuru MBA's HeartWare Inc Experience June 2010 - Present
Job Sr. Mechanical Engineer at HeartWare Inc
Industry Medical Devices
Experience
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

Erin Blattenberger Erin Blattenberger Devon, Pennsylvania Details
Erin Blattenberger's HeartWare Inc Experience July 2014 - Present
Job Territory Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Lynn Desroches Lynn Desroches Miami/Fort Lauderdale Area Details
Lynn Desroches's HeartWare Inc Experience July 2012 - July 2014
Job Clinician, Product Safety and Performance at Cordis
Industry Medical Devices
Experience
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

Michael Tajima Michael Tajima Greater Boston Area Details
Michael Tajima's HeartWare Inc Experience November 2011 - Present
Job Sr. Product Manager at HeartWare Inc
Industry Mechanical or Industrial Engineering
Experience
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

Peter McAree Peter McAree Greater Boston Area Details
Peter McAree's HeartWare Inc Experience July 2012 - Present
Job Senior Vice President & CFO at HeartWare Inc
Industry Biotechnology
Experience
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

Josue Josh Servalis Josue Josh Servalis Miami/Fort Lauderdale Area Details
Josue Josh Servalis's HeartWare Inc Experience March 2014 - Present
Job Sr. Manufacturing Engineer at HeartWare Inc
Industry Medical Devices
Experience
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

Betzaida Hernandez Betzaida Hernandez Greater Los Angeles Area Details
Betzaida Hernandez's HeartWare Inc Experience March 2015 - May 2015
Job Algorithm Development Engineer at Medtronic
Industry Biotechnology
Experience
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

Darleen Alexander Louis Darleen Alexander Louis Miami/Fort Lauderdale Area Details
Darleen Alexander Louis's HeartWare Inc Experience 2013 - Present
Job Project Coordinator at HeartWare, Inc.
Industry Real Estate
Experience
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

Alan Oslan Alan Oslan Greater Boston Area Details
Alan Oslan's HeartWare Inc Experience July 2011 - June 2014
Job President & Founder at ElectroSurge, LLC
Industry Medical Devices
Experience
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

Matt Mozur Matt Mozur Greater Boston Area Details
Matt Mozur's HeartWare Inc Experience April 2011 - Present
Job Engineering Manager Electrical Hardware Group at HeartWare Inc
Industry Medical Devices
Experience
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

Eliel Garcia Eliel Garcia Raleigh-Durham, North Carolina Area Details
Eliel Garcia's HeartWare Inc Experience August 2006 - March 2007
Job Quality Assurance Professional
Industry Biotechnology
Experience
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

Peter Chakoutis Peter Chakoutis Greater Boston Area Details
Peter Chakoutis's HeartWare Inc Experience May 2015 - Present
Job Director of Sales & Marketing Operations at HeartWare Inc
Industry Biotechnology
Experience
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

Sherri Moyen Sherri Moyen Greater Boston Area Details
Sherri Moyen's HeartWare Inc Experience February 2009 - May 2009
Job Corporate Controller at Aspect Software
Industry Computer Software
Experience
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

Dominic Cappelletti Dominic Cappelletti Louisville, Kentucky Area Details
Dominic Cappelletti's HeartWare Inc Experience January 2008 - January 2010
Job Clinical Perfusionist at University Cardiothoracic Surgical Associates/ University of Louisville Physicians.
Industry Medical Practice
Experience
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

Ralph Turhanbey Ng Ralph Turhanbey Ng Miami/Fort Lauderdale Area Details
Ralph Turhanbey Ng's HeartWare Inc Experience July 2007 - May 2009
Job On Call Consultant to Device Technology Consultant
Industry Medical Devices
Experience
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

Stephen Alam Stephen Alam Providence, Rhode Island Area Details
Stephen Alam's HeartWare Inc Experience March 2013 - Present
Job Senior Software Engineer at HeartWare Inc
Industry Biotechnology
Experience
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

Frank Butaric Frank Butaric Miami/Fort Lauderdale Area Details
Frank Butaric's HeartWare Inc Experience January 2008 - Present
Job Principal tecnician at Cordis
Industry Medical Devices
Experience
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

Kristen Foust - Smith Kristen Foust - Smith Miami/Fort Lauderdale Area Details
Kristen Foust - Smith's HeartWare Inc Experience August 2006 - June 2007
Job Sr Nuclear Analyst at Florida Power & Light
Industry Medical Devices
Experience
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

Pablo Arnold Guerra Pablo Arnold Guerra Miami/Fort Lauderdale Area Details
Pablo Arnold Guerra's HeartWare Inc Experience 2010 - 2011
Job Engineering Consultant and Project Lead Medical Devices and Compliance.
Industry Medical Devices
Experience
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

Bill Eifert Bill Eifert Miami/Fort Lauderdale Area Details
Bill Eifert's HeartWare Inc Experience October 2009 - February 2010
Job Validation Consultant at Edwards Lifesciences
Industry Medical Devices
Experience
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

Chris Wyman Chris Wyman Greater Boston Area Details
Chris Wyman's HeartWare Inc Experience December 2014 - Present
Job Principal Quality Statistician at HeartWare Inc
Industry Medical Devices
Experience
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

Jason Hokama, PhD Jason Hokama, PhD Greater Los Angeles Area Details
Jason Hokama, PhD's HeartWare Inc Experience March 2013 - Present
Job Scientific Medical Affairs Manager at HeartWare Inc
Industry Medical Devices
Experience
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.

Cassandra Quilala-Nickel Cassandra Quilala-Nickel Petaluma, California Details
Cassandra Quilala-Nickel's HeartWare Inc Experience April 2015 - Present
Job Contractor at HeartWare Inc
Industry Medical Devices
Experience
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

Jeffrey Curtis Jeffrey Curtis Greater Boston Area Details
Jeffrey Curtis's HeartWare Inc Experience March 2014 - March 2015
Job Group Manager, Commercial Therapy @ Stryker Neurovascular
Industry Medical Devices
Experience
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

Jennifer C. Babitsky Jennifer C. Babitsky Greater Boston Area Details
Jennifer C. Babitsky's HeartWare Inc Experience July 2012 - Present
Job HR Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Vaughn Usher Vaughn Usher Miami/Fort Lauderdale Area Details
Vaughn Usher's HeartWare Inc Experience December 2002 - November 2005
Job Product Development Engineer at Nipro Diabetes Systems
Industry Medical Devices
Experience
Nipro Diabetes Systems  December 2005 - Present
HeartWare Inc   December 2002 - November 2005
Cordis/Johnson & Johnson   1983 - 2002

Education
Barry University

Miami Dade College

Tatyana Chorny Tatyana Chorny Miami/Fort Lauderdale Area Details
Tatyana Chorny's HeartWare Inc Experience December 2014 - Present
Job Manager, Complaints at HeartWare Inc
Industry Medical Devices
Experience
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

Dayami Lopez Dayami Lopez Miami/Fort Lauderdale Area Details
Dayami Lopez's HeartWare Inc Experience May 2012 - Present
Job Senior Process Development Engineer at HeartWare Inc
Industry Medical Devices
Experience
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

Vaughn Usher Vaughn Usher Miami/Fort Lauderdale Area Details
Vaughn Usher's HeartWare Inc Experience November 2002 - September 2005
Job Mechanical · Electrical · BioMedical · Manufacturing · Product & Process Design · Engineering & Leadership
Industry Medical Devices
Experience
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

Adolfo Sotil Adolfo Sotil Miami/Fort Lauderdale Area Details
Adolfo Sotil's HeartWare Inc Experience January 2012 - Present
Job Senior Accountant at Heartware Inc.
Industry Hospitality
Experience
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

Harry Rubright Harry Rubright Miami/Fort Lauderdale Area Details
Harry Rubright's HeartWare Inc Experience May 2002 - Present
Job Manufacturing Engineer at HeartWare Inc
Industry Medical Devices
Experience
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

Ryun Guthrie Ryun Guthrie Dallas/Fort Worth Area Details
Ryun Guthrie's HeartWare Inc Experience July 2013 - Present
Job Territory Manager North Texas/Arkansas at HeartWare Inc
Industry Medical Devices
Experience
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

Alexander Capo Alexander Capo Miami/Fort Lauderdale Area Details
Alexander Capo's HeartWare Inc Experience June 2010 - Present
Job Test Engineer
Industry Medical Devices
Experience
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

Christopher Linden Christopher Linden Miami/Fort Lauderdale Area Details
Christopher Linden's HeartWare Inc Experience July 2014 - Present
Job Principal Mechanical Engineer at HeartWare Inc
Industry Medical Devices
Experience
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

Kristin Neff Kristin Neff Greater Boston Area Details
Kristin Neff's HeartWare Inc Experience August 2008 - April 2009
Job VP of Clinical Operations and Project Management at InVivo Therapeutics
Industry Medical Devices
Experience
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

Rosario Chinchay Rosario Chinchay Miami/Fort Lauderdale Area Details
Rosario Chinchay's HeartWare Inc Experience February 2013 - January 2015
Job Senior Accountant at Zumba
Industry Accounting
Experience
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

Osvaldo Perez-Maiy Osvaldo Perez-Maiy Miami/Fort Lauderdale Area Details
Osvaldo Perez-Maiy's HeartWare Inc Experience September 2013 - August 2014
Job RN Care Team Manager at AIDS Healthcare Foundation
Industry Hospital & Health Care
Experience
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

Doug Godshall Doug Godshall Greater Boston Area Details
Doug Godshall's HeartWare Inc Experience September 2006 - Present
Job CEO at HeartWare Inc
Industry Medical Devices
Experience
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

Vivian Perez, MBA, RAC Vivian Perez, MBA, RAC Miami/Fort Lauderdale Area Details
Vivian Perez, MBA, RAC's HeartWare Inc Experience November 2011 - Present
Job Regulatory Affairs Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Dana Vittum, CPA/PFS CFP Dana Vittum, CPA/PFS CFP Greater Boston Area Details
Dana Vittum, CPA/PFS CFP's HeartWare Inc Experience January 2015 - Present
Job Director Tax and Treasury at HeartWare Inc
Industry Accounting
Experience
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

Michael Ashenuga Michael Ashenuga Greater Boston Area Details
Michael Ashenuga's HeartWare Inc Experience April 2008 - Present
Job Senior Global Product Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Eric Darcy Eric Darcy San Francisco Bay Area Details
Eric Darcy's HeartWare Inc Experience October 2011 - April 2013
Job Quality Engineer at AlterG
Industry Medical Devices
Experience
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

Vega Augusto Vega Augusto Miami/Fort Lauderdale Area Details
Vega Augusto's HeartWare Inc Experience Sr. PlannerBolton Medical2004 - 2006
Job Supply Chain Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Stuart Logan Stuart Logan Greater Boston Area Details
Stuart Logan's HeartWare Inc Experience February 2014 - Present
Job Director, New Business Development and Strategic Planning at HeartWare Inc
Industry Medical Devices
Experience
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

Karina Hernandez Karina Hernandez Miami/Fort Lauderdale Area Details
Karina Hernandez's HeartWare Inc Experience September 2014 - February 2015
Job Human Resources
Industry Human Resources
Experience
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

Raymond Diaz Raymond Diaz Miami/Fort Lauderdale Area Details
Raymond Diaz's HeartWare Inc Experience April 2012 - Present
Job Senior Director of Manufacturing & Production Support at HeartWare Inc
Industry Medical Devices
Experience
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

Vega Augusto Vega Augusto Miami/Fort Lauderdale Area Details
Vega Augusto's HeartWare Inc Experience PlannerIVAX2002 - 2004
Job Supply Chain Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc   PlannerIVAX2002 - 2004

Skills
FDA

Education
Florida International University   2000 — 2004
Bachelor, International Business

Alan Gill Alan Gill Miami/Fort Lauderdale Area Details
Alan Gill's HeartWare Inc Experience 2010 - Present
Job Principal Process Development Engineer
Industry Medical Devices
Experience
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

Nitin Ghige Nitin Ghige Framingham, Massachusetts Details
Nitin Ghige's HeartWare Inc Experience September 2014 - Present
Job Technical Lead Hardware at Capgemini (iGATE)
Industry Medical Devices
Experience
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

Janny Garcia Janny Garcia Miami/Fort Lauderdale Area Details
Janny Garcia's HeartWare Inc Experience May 2013 - Present
Job Clinical Engineer
Industry Medical Devices
Experience
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

Jing Yu Jing Yu Belmont, Massachusetts Details
Jing Yu's HeartWare Inc Experience October 2014 - Present
Job Statistician II at HeartWare Inc
Industry Hospital & Health Care
Experience
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

John-Michael Sungur John-Michael Sungur Greater Boston Area Details
John-Michael Sungur's HeartWare Inc Experience 2015 - Present
Job Product Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Angelica Pabon Angelica Pabon Greater Boston Area Details
Angelica Pabon's HeartWare Inc Experience July 2014 - Present
Job Administrative Assistant at HeartWare Inc.
Industry Medical Devices
Experience
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

Bill Gearhart Bill Gearhart Miami/Fort Lauderdale Area Details
Bill Gearhart's HeartWare Inc Experience April 2015 - Present
Job Manufacturing Controller at HeartWare Inc
Industry Packaging and Containers
Experience
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

Rozelle Smith, MSQSM, CQA Rozelle Smith, MSQSM, CQA Miami/Fort Lauderdale Area Details
Rozelle Smith, MSQSM, CQA's HeartWare Inc Experience February 2011 - March 2015
Job Director of QA at ECI Pharmaceuticals LLC
Industry Pharmaceuticals
Experience
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

Esteban Molina Esteban Molina Miami/Fort Lauderdale Area Details
Esteban Molina's HeartWare Inc Experience March 2011 - Present
Job Test engineer
Industry Medical Devices
Experience
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

Manuel Pagan Manuel Pagan Miami/Fort Lauderdale Area Details
Manuel Pagan's HeartWare Inc Experience October 2010 - Present
Job QAEE/MDT at HeartWare Inc
Industry Medical Devices
Experience
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

Antonio Daniel Antonio Daniel Miami/Fort Lauderdale Area Details
Antonio Daniel's HeartWare Inc Experience January 2012 - June 2012
Job Senior Mechanical Designer
Industry Mechanical or Industrial Engineering
Experience
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

Ming Jay Chow Ming Jay Chow Greater Boston Area Details
Ming Jay Chow's HeartWare Inc Experience February 2014 - Present
Job Medical Writer at HeartWare Inc
Industry Mechanical or Industrial Engineering
Experience
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

David A. Llana David A. Llana Miami/Fort Lauderdale Area Details
David A. Llana's HeartWare Inc Experience March 2014 - May 2014
Job MEDICAL DEVICE ENGINEERING CONSULTANT
Industry Medical Devices
Experience
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

Erika Campos Erika Campos Miami, Florida Details
Erika Campos's HeartWare Inc Experience October 2012 - Present
Job Senior Product Specialist
Industry Medical Devices
Experience
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

Neal Moawed Neal Moawed Greater Boston Area Details
Neal Moawed's HeartWare Inc Experience June 2014 - August 2014
Job CustomerFocused Life Sciences Marketing Professional
Industry Biotechnology
Experience
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

Jennifer Rautine Jennifer Rautine Erie, Pennsylvania Area Details
Jennifer Rautine's HeartWare Inc Experience January 2009 - January 2010
Job Director of Sales/Marketing and Clinical Operations
Industry Medical Devices
Experience
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

Veronica Ramos Veronica Ramos Miami, Florida Details
Veronica Ramos's HeartWare Inc Experience October 2013 - Present
Job Clinical Engineer at HeartWare Inc
Industry Computer Networking
Experience
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

Jane Gates Jane Gates Fort Lauderdale, Florida Details
Jane Gates's HeartWare Inc Experience March 2012 - Present
Job Training Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Michelle Valentine Michelle Valentine Monclova, Ohio Details
Michelle Valentine's HeartWare Inc Experience February 2013 - Present
Job Territory Manager at HeartWare Inc
Industry Medical Devices
Experience
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

Anthony Palacios Anthony Palacios Miami, Florida Details
Anthony Palacios's HeartWare Inc Experience March 2015 - Present
Job Quality Engineer at HeartWare
Industry Medical Devices
Experience
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

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