HeartWare Inc
Industry: Company
DescriptionHeadquarters: Framingham, MA Parent organization: Medtronic, Inc. Subsidiaries: HeartWare Inc, HeartWare Ltd
HeartWare Inc List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at HeartWare Inc. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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HeartWare Inc Employees
Employee
Years
Job
Industry
Keely Langdon Keely Langdon's HeartWare Inc Experience January 2015 - Present
Job New Business Development and Strategic Marketing Analyst at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2015 - Present
Health Advances December 2014 - January 2015
Health Advances March 2013 - December 2014
Health Advances August 2011 - March 2013
Lindner Capital Advisors June 2010 - August 2010
DoCare International January 2010 - February 2010
Skills
Data Analysis, Primary Research, Pharmaceutical Industry, Biotechnology, Medical Devices, Medical Diagnostics, Strategy, Commercialization
Education
University of Pennsylvania 2007 — 2011
Bachelor of Arts, Health and Societies, Health Care Markets and Finance
HeartWare Inc January 2015 - Present
Health Advances December 2014 - January 2015
Health Advances March 2013 - December 2014
Health Advances August 2011 - March 2013
Lindner Capital Advisors June 2010 - August 2010
DoCare International January 2010 - February 2010
Skills
Data Analysis, Primary Research, Pharmaceutical Industry, Biotechnology, Medical Devices, Medical Diagnostics, Strategy, Commercialization
Education
University of Pennsylvania 2007 — 2011
Bachelor of Arts, Health and Societies, Health Care Markets and Finance
Nathan Longtin Nathan Longtin's HeartWare Inc Experience February 2014 - March 2015
Job Process Validation Engineer at Tecomet
Industry Medical Devices
Experience
Tecomet March 2015 - Present
HeartWare Inc February 2014 - March 2015
Thomas Publishing June 2013 - September 2013
University of Rhode Island May 2009 - May 2013
Skills
Medical Devices, Biomedical Engineering, V&V, Validation, System Requirements, Design Control, Scrum, Electronics, Mathematics, Computers, Analysis, cGMP, SOP, Databases, Business, Time Management, Management, Problem Resolution, Customer Service, Microsoft Excel, Teamwork, Basic Windows...
Education
University of Rhode Island 2007 — 2013
Bachelor of Science (B.S.), Mathematics
Smithfield High School 2003 — 2007
Academy of Finance
Tecomet March 2015 - Present
HeartWare Inc February 2014 - March 2015
Thomas Publishing June 2013 - September 2013
University of Rhode Island May 2009 - May 2013
Skills
Medical Devices, Biomedical Engineering, V&V, Validation, System Requirements, Design Control, Scrum, Electronics, Mathematics, Computers, Analysis, cGMP, SOP, Databases, Business, Time Management, Management, Problem Resolution, Customer Service, Microsoft Excel, Teamwork, Basic Windows...
Education
University of Rhode Island 2007 — 2013
Bachelor of Science (B.S.), Mathematics
Smithfield High School 2003 — 2007
Academy of Finance
Roberto Refeca Roberto Refeca's HeartWare Inc Experience August 2008 - May 2010
Job Associate Director Regulatory Affairs at Halyard Health
Industry Medical Devices
Experience
Halyard Health November 2014 - Present
Kimberly-Clark January 2013 - October 2014
Abbott Vascular April 2010 - January 2013
HeartWare Inc August 2008 - May 2010
Cordis Neurovascular a Johnson & Johnson Co. 2005 - 2008
Scripps Florida February 2003 - March 2004
DRI-University of Miami February 1999 - March 2004
Skills
Medical Devices, Design of Experiments, EMEA, APAC, IDE, Clinical Trials, Project Management, FDA, Regulatory Affairs, CAPA, Design Control, ISO 13485, ISO 14971, Biotechnology, Regulatory Submissions, V&V, Sop, International..., Validation, PMA, Change Control, 21 CFR Part 11, Regulatory Requirements, CE marking, Clinical Development, Quality System
Education
University of Miami - School of Business 2002 — 2004
MBA, Management
Maryville University 1995 — 1998
BS, Biology/Chemistry
Halyard Health November 2014 - Present
Kimberly-Clark January 2013 - October 2014
Abbott Vascular April 2010 - January 2013
HeartWare Inc August 2008 - May 2010
Cordis Neurovascular a Johnson & Johnson Co. 2005 - 2008
Scripps Florida February 2003 - March 2004
DRI-University of Miami February 1999 - March 2004
Skills
Medical Devices, Design of Experiments, EMEA, APAC, IDE, Clinical Trials, Project Management, FDA, Regulatory Affairs, CAPA, Design Control, ISO 13485, ISO 14971, Biotechnology, Regulatory Submissions, V&V, Sop, International..., Validation, PMA, Change Control, 21 CFR Part 11, Regulatory Requirements, CE marking, Clinical Development, Quality System
Education
University of Miami - School of Business 2002 — 2004
MBA, Management
Maryville University 1995 — 1998
BS, Biology/Chemistry
Nathalie Nunez Nathalie Nunez's HeartWare Inc Experience July 2015 - Present
Job Clinical Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc July 2015 - Present
HeartWare Inc June 2013 - July 2015
HeartWare Inc October 2010 - June 2013
University of Miami, Miller School of Medicine January 2010 - October 2010
Skills
Instrumentation, Microsoft Office, Programming, Logistics, Protocol Design, Testing, Procedure Development, Field Service, Animal Work, Clinical Research, Design Control, Medical Devices, ISO 13485, ISO 14971, FDA, Biomedical Engineering, R, CAPA, Design of Experiments, Quality System
Education
Univeristy of Miami 2010 — 2011
Master of Science (MS), Biomedical/Medical Engineering
University of Miami 2006 — 2011
Bachelor of Science (BS), Biomedical/Medical Engineering
HeartWare Inc July 2015 - Present
HeartWare Inc June 2013 - July 2015
HeartWare Inc October 2010 - June 2013
University of Miami, Miller School of Medicine January 2010 - October 2010
Skills
Instrumentation, Microsoft Office, Programming, Logistics, Protocol Design, Testing, Procedure Development, Field Service, Animal Work, Clinical Research, Design Control, Medical Devices, ISO 13485, ISO 14971, FDA, Biomedical Engineering, R, CAPA, Design of Experiments, Quality System
Education
Univeristy of Miami 2010 — 2011
Master of Science (MS), Biomedical/Medical Engineering
University of Miami 2006 — 2011
Bachelor of Science (BS), Biomedical/Medical Engineering
Jorge Salas, PE Jorge Salas, PE's HeartWare Inc Experience October 2014 - Present
Job Sr. Manufaturing Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc October 2014 - Present
Medtronic June 2009 - September 2014
Maquet Cardiovascular April 2006 - June 2009
Hamilton Sundstrand June 2004 - July 2004
Skills
Root Cause Analysis, Lean Manufacturing, Design for Manufacturing, Six Sigma, CAPA, CAD, ANSYS, Manufacturing Operations, Solidworks, AutoCad, AutoCAD Mechanical, Layout, Statistical Data..., Cost Reduction..., Cost Reduction..., Engineering Change..., Test Validation, New product, New Product..., Computer System..., Gage R&R, Medical Devices, Minitab, SolidWorks, FDA, Manufacturing, Mechanical Engineering, ISO 13485, FMEA, Quality System, DMAIC
Education
Universidad Politecnica de Puerto Rico 2013 — 2016
Master in Engineering Management
University of Puerto Rico-Mayaguez 2000 — 2006
Bachelor of Science (B.S.), Mechanical Engineering
HeartWare Inc October 2014 - Present
Medtronic June 2009 - September 2014
Maquet Cardiovascular April 2006 - June 2009
Hamilton Sundstrand June 2004 - July 2004
Skills
Root Cause Analysis, Lean Manufacturing, Design for Manufacturing, Six Sigma, CAPA, CAD, ANSYS, Manufacturing Operations, Solidworks, AutoCad, AutoCAD Mechanical, Layout, Statistical Data..., Cost Reduction..., Cost Reduction..., Engineering Change..., Test Validation, New product, New Product..., Computer System..., Gage R&R, Medical Devices, Minitab, SolidWorks, FDA, Manufacturing, Mechanical Engineering, ISO 13485, FMEA, Quality System, DMAIC
Education
Universidad Politecnica de Puerto Rico 2013 — 2016
Master in Engineering Management
University of Puerto Rico-Mayaguez 2000 — 2006
Bachelor of Science (B.S.), Mechanical Engineering
Monica Costello Monica Costello's HeartWare Inc Experience June 2014 - August 2014
Job Business Development Representative at Acquia
Industry Computer Software
Experience
Acquia 2015 - Present
Rhodes College August 2012 - Present
FedEx September 2014 - December 2014
HeartWare Inc June 2014 - August 2014
Green Streets Initiative May 2013 - July 2013
Rhodes College September 2011 - May 2012
Skills
Microsoft Excel, Cold Calling, Microsoft Office, Social Media, Time Management, Fundraising, Management, Customer Service, Leadership, Google Analytics, Camtasia, PowerPoint, Public Speaking
Education
Rhodes College 2012 — 2015
Bachelor of Science (B.S.), Economics/Commerce and Business Double Major, Junior
Oxford University 2013 — 2013
Foundations of Western Civilization
Acquia 2015 - Present
Rhodes College August 2012 - Present
FedEx September 2014 - December 2014
HeartWare Inc June 2014 - August 2014
Green Streets Initiative May 2013 - July 2013
Rhodes College September 2011 - May 2012
Skills
Microsoft Excel, Cold Calling, Microsoft Office, Social Media, Time Management, Fundraising, Management, Customer Service, Leadership, Google Analytics, Camtasia, PowerPoint, Public Speaking
Education
Rhodes College 2012 — 2015
Bachelor of Science (B.S.), Economics/Commerce and Business Double Major, Junior
Oxford University 2013 — 2013
Foundations of Western Civilization
Bill Wiggins Bill Wiggins's HeartWare Inc Experience November 2014 - August 2015
Job Sr. Manager, Field Assurance at MicroVention Terumo
Industry Medical Devices
Experience
MicroVention Terumo August 2015 - Present
HeartWare Inc November 2014 - August 2015
R & Q Solutions April 2014 - October 2014
Maetrics, LLC August 2012 - April 2014
Medical Device/Biotech February 2012 - September 2012
Medtronic April 2001 - January 2012
Vistakon, Inc March 1989 - April 2001
Skills
FDA, Quality Assurance, Quality Management, CAPA, Medical Devices, Validation, Sop, Cross-functional Team..., ISO 13485, V&V, Software Project..., Quality System, Auditing, Healthcare, GMP, Quality Complaint..., GMP Compliance Audits..., Quality Management..., 21 CFR Part 11, Team Management, Product Launch, SOPs, policies, plans,..., 21 CFR Parts 11, 803 &..., Quality Auditor, ISO, Continuous Improvement, Product Development, Complaint Management, Training, Design Control, Leadership, ISO 14971, Change Management, Quality Auditing, Regulatory Affairs, Coaching, Staff Development, Global Staff Management, Management, SOP
Education
University of Phoenix 2007 — 2010
BS, Nursing
Florida State College at Jacksonville
AS, Nursing
MicroVention Terumo August 2015 - Present
HeartWare Inc November 2014 - August 2015
R & Q Solutions April 2014 - October 2014
Maetrics, LLC August 2012 - April 2014
Medical Device/Biotech February 2012 - September 2012
Medtronic April 2001 - January 2012
Vistakon, Inc March 1989 - April 2001
Skills
FDA, Quality Assurance, Quality Management, CAPA, Medical Devices, Validation, Sop, Cross-functional Team..., ISO 13485, V&V, Software Project..., Quality System, Auditing, Healthcare, GMP, Quality Complaint..., GMP Compliance Audits..., Quality Management..., 21 CFR Part 11, Team Management, Product Launch, SOPs, policies, plans,..., 21 CFR Parts 11, 803 &..., Quality Auditor, ISO, Continuous Improvement, Product Development, Complaint Management, Training, Design Control, Leadership, ISO 14971, Change Management, Quality Auditing, Regulatory Affairs, Coaching, Staff Development, Global Staff Management, Management, SOP
Education
University of Phoenix 2007 — 2010
BS, Nursing
Florida State College at Jacksonville
AS, Nursing
Jessica Shuman's HeartWare Inc Experience March 2014 - January 2015
Job Vascular Product Expert at BSI America
Industry Medical Devices
Experience
BSI America February 2015 - Present
HeartWare Inc March 2014 - January 2015
HeartWare Inc March 2011 - March 2014
HeartWare Inc July 2008 - March 2011
Boston Scientific July 2007 - July 2008
Biotecknica December 2006 - July 2007
Cordis Neurovascular Johnson and Johnson May 2005 - December 2006
Arrow International May 2002 - May 2005
Skills
Medical Devices, Design Control, ISO 13485, Six Sigma, ISO 14971, CAPA, Product Development, Validation, Process Simulation, PMP, V&V, FDA, Quality Assurance, R&D, FMEA, Design of Experiments, GMP, Quality System, Project Management
Education
University of Pittsburgh 1997 — 2002
BS, Bioengineering - BioTechnology
BSI America February 2015 - Present
HeartWare Inc March 2014 - January 2015
HeartWare Inc March 2011 - March 2014
HeartWare Inc July 2008 - March 2011
Boston Scientific July 2007 - July 2008
Biotecknica December 2006 - July 2007
Cordis Neurovascular Johnson and Johnson May 2005 - December 2006
Arrow International May 2002 - May 2005
Skills
Medical Devices, Design Control, ISO 13485, Six Sigma, ISO 14971, CAPA, Product Development, Validation, Process Simulation, PMP, V&V, FDA, Quality Assurance, R&D, FMEA, Design of Experiments, GMP, Quality System, Project Management
Education
University of Pittsburgh 1997 — 2002
BS, Bioengineering - BioTechnology
Todor Mihajloski Todor Mihajloski's HeartWare Inc Experience September 2015 - Present
Job Clinical Engineering Intern at HeartWare Inc.
Industry Medical Devices
Experience
HeartWare Inc September 2015 - Present
HeartWare Inc January 2013 - Present
Skills
Matlab, Labview, MySQL, HTML, C/C++, C#, Electronics, php, Embedded Systems, Java, Medical Devices, Digital Signal..., Microsoft Office, Customer Service, Time Management, Team Leadership, Teaching, Student Mentoring, Android Development, Biomedical Engineering, C++
Education
University of Miami 2012 — 2015
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
University of Miami 2010 — 2011
Master of Science (M.S.), Biomedical/Medical Engineering
University of Miami 2006 — 2010
Bachelor of Science (B.S.), Biomedical/Medical Engineering
HeartWare Inc September 2015 - Present
HeartWare Inc January 2013 - Present
Skills
Matlab, Labview, MySQL, HTML, C/C++, C#, Electronics, php, Embedded Systems, Java, Medical Devices, Digital Signal..., Microsoft Office, Customer Service, Time Management, Team Leadership, Teaching, Student Mentoring, Android Development, Biomedical Engineering, C++
Education
University of Miami 2012 — 2015
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
University of Miami 2010 — 2011
Master of Science (M.S.), Biomedical/Medical Engineering
University of Miami 2006 — 2010
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Nicole Simpson Nicole Simpson's HeartWare Inc Experience February 2013 - Present
Job Verification and Validation Engineer II at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc February 2013 - Present
Siemens Healthcare November 2011 - February 2013
University of Rochester May 2009 - May 2010
University of Rochester Medical Center January 2008 - May 2009
ValSource, LLC May 2007 - August 2008
Skills
Matlab, Labview, Algorithms, Biomedical Engineering, Testing
Education
University of Pennsylvania 2010 — 2011
MEng, Bioengineering
University of Rochester 2006 — 2010
BS, Biomedical Engineer
HeartWare Inc February 2013 - Present
Siemens Healthcare November 2011 - February 2013
University of Rochester May 2009 - May 2010
University of Rochester Medical Center January 2008 - May 2009
ValSource, LLC May 2007 - August 2008
Skills
Matlab, Labview, Algorithms, Biomedical Engineering, Testing
Education
University of Pennsylvania 2010 — 2011
MEng, Bioengineering
University of Rochester 2006 — 2010
BS, Biomedical Engineer
Ximena Vial, PhD Ximena Vial, PhD's HeartWare Inc Experience October 2012 - June 2013
Job VAD Bioengineer Jackson Memorial Hospital
Industry Biotechnology
Experience
University of Miami January 2014 - Present
Jackson Memorial Hospital May 2013 - Present
University of Miami January 2011 - December 2013
University of Miami June 2006 - December 2013
HeartWare Inc October 2012 - June 2013
Skills
Biomaterials, Biomedical Engineering, Fluorescence Microscopy, Cell Culture, Western Blotting, Microscopy, Immunohistochemistry, Gel Electrophoresis, Molecular Biology, Cell Biology, Tissue Engineering, Flow Cytometry, Labview, Biochemistry, Lifesciences, ImageJ, Image Processing, Data Analysis, Biotechnology, Research, Medical Devices
Education
University of Miami 2009 — 2013
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
University of Miami 2006 — 2008
Master of Science (M.S.), Biomedical/Medical Engineering
University of Miami January 2014 - Present
Jackson Memorial Hospital May 2013 - Present
University of Miami January 2011 - December 2013
University of Miami June 2006 - December 2013
HeartWare Inc October 2012 - June 2013
Skills
Biomaterials, Biomedical Engineering, Fluorescence Microscopy, Cell Culture, Western Blotting, Microscopy, Immunohistochemistry, Gel Electrophoresis, Molecular Biology, Cell Biology, Tissue Engineering, Flow Cytometry, Labview, Biochemistry, Lifesciences, ImageJ, Image Processing, Data Analysis, Biotechnology, Research, Medical Devices
Education
University of Miami 2009 — 2013
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
University of Miami 2006 — 2008
Master of Science (M.S.), Biomedical/Medical Engineering
Lance Farb Lance Farb's HeartWare Inc Experience September 2015 - Present
Job Human Factors Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc September 2015 - Present
Baxter International Inc. November 2013 - Present
University of Michigan Health System May 2013 - June 2013
University of Michigan’s Biomedical Science Research Building January 2013 - April 2013
University of Michigan Health System January 2012 - April 2012
Skills
Data Analysis, Statistics, Matlab, PCR, Hip, Anesthesiology, Orthopedic, Elbow, Knee, ICU, Human Factors..., Human Factors, Heuristic Evaluation, Usability Engineering, FMEA, Genetic Engineering, CAPA, Industrial Design, Risk Management, Risk Assessment, Risk Analysis, Usability Testing, Formative Assessment, Product Development, Product Requirements, Use Case Analysis, Use Case Diagrams, Product Requirement..., Rapid Prototyping, Medical Devices, Medical Device R&D, Formal Verification, Test Validation, Testing, Study Monitoring, Continuous Improvement, Records Management, Design Control, GMP, GDP, User-centered Design, R&D, User Research, Microsoft Office, CAD/CAM, C++, Java, LabVIEW
Education
University of Michigan 2008 — 2013
Bachelor’s Degree, Biomedical/Medical Engineering, 3.3/4.0
Glenbrook North 2004 — 2008
High School, 4.2/5.0
HeartWare Inc September 2015 - Present
Baxter International Inc. November 2013 - Present
University of Michigan Health System May 2013 - June 2013
University of Michigan’s Biomedical Science Research Building January 2013 - April 2013
University of Michigan Health System January 2012 - April 2012
Skills
Data Analysis, Statistics, Matlab, PCR, Hip, Anesthesiology, Orthopedic, Elbow, Knee, ICU, Human Factors..., Human Factors, Heuristic Evaluation, Usability Engineering, FMEA, Genetic Engineering, CAPA, Industrial Design, Risk Management, Risk Assessment, Risk Analysis, Usability Testing, Formative Assessment, Product Development, Product Requirements, Use Case Analysis, Use Case Diagrams, Product Requirement..., Rapid Prototyping, Medical Devices, Medical Device R&D, Formal Verification, Test Validation, Testing, Study Monitoring, Continuous Improvement, Records Management, Design Control, GMP, GDP, User-centered Design, R&D, User Research, Microsoft Office, CAD/CAM, C++, Java, LabVIEW
Education
University of Michigan 2008 — 2013
Bachelor’s Degree, Biomedical/Medical Engineering, 3.3/4.0
Glenbrook North 2004 — 2008
High School, 4.2/5.0
Deepakkumar Ailani Deepakkumar Ailani's HeartWare Inc Experience October 2014 - Present
Job Project Lead [Verification & Validation] at HeartWare Inc (for IGATE Technologies Inc.)
Industry Computer Software
Experience
HeartWare Inc October 2014 - Present
Haemonetics August 2013 - October 2014
GE Healthcare March 2012 - August 2013
Alcon, a Novartis company January 2011 - March 2012
Patni Computer Systems Ltd August 2006 - June 2009
Skills
Java, Testing, Software Engineering, Test Automation, Linux, Tomcat, Oracle, MySQL, AJAX, Unix, Servlets, JSP, XML, Databases, Medical Devices, Agile Methodologies
Education
University of Southern California 2009 — 2011
Masters of Science, Computer Science
University of Mumbai 2002 — 2006
BE - IT, Information Technology, First Class with Distinction
HeartWare Inc October 2014 - Present
Haemonetics August 2013 - October 2014
GE Healthcare March 2012 - August 2013
Alcon, a Novartis company January 2011 - March 2012
Patni Computer Systems Ltd August 2006 - June 2009
Skills
Java, Testing, Software Engineering, Test Automation, Linux, Tomcat, Oracle, MySQL, AJAX, Unix, Servlets, JSP, XML, Databases, Medical Devices, Agile Methodologies
Education
University of Southern California 2009 — 2011
Masters of Science, Computer Science
University of Mumbai 2002 — 2006
BE - IT, Information Technology, First Class with Distinction
Garabed Tashian Garabed Tashian's HeartWare Inc Experience March 2012 - March 2013
Job Biomedical Engineer
Industry Biotechnology
Experience
ABM Industries April 2014 - Present
Armenian Youth Federation Eastern Region January 2014 - Present
Physicians Resource Network December 2013 - February 2014
Armenian Youth Federation Eastern Region January 2012 - December 2013
HeartWare Inc March 2012 - March 2013
Department of Veterans Affairs June 2011 - August 2011
Skills
Matlab, Biomedical Engineering, Validation, Medical Devices, FDA, ISO 13485, Public Speaking, Management, Circuit Design, Leadership, Test Cases, Microsoft Office, Microsoft Excel, Testing, Biotechnology, Customer Service, Microsoft Word, Seapine Test Track Pro, Product Management, Babylog 8000 Ventilator
Education
University of Rhode Island 2009 — 2013
Bachelor of Engineering (BEng), Biomedical Engineering
ABM Industries April 2014 - Present
Armenian Youth Federation Eastern Region January 2014 - Present
Physicians Resource Network December 2013 - February 2014
Armenian Youth Federation Eastern Region January 2012 - December 2013
HeartWare Inc March 2012 - March 2013
Department of Veterans Affairs June 2011 - August 2011
Skills
Matlab, Biomedical Engineering, Validation, Medical Devices, FDA, ISO 13485, Public Speaking, Management, Circuit Design, Leadership, Test Cases, Microsoft Office, Microsoft Excel, Testing, Biotechnology, Customer Service, Microsoft Word, Seapine Test Track Pro, Product Management, Babylog 8000 Ventilator
Education
University of Rhode Island 2009 — 2013
Bachelor of Engineering (BEng), Biomedical Engineering
Felix Le Felix Le's HeartWare Inc Experience April 2015 - Present
Job Medical Device Quality Consultant at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc April 2015 - Present
Biomet 3i May 2014 - February 2015
Smith & Nephew January 2014 - April 2014
Hospira August 2013 - December 2013
Terumo Medical January 2011 - August 2013
St. Jude Medical 2010 - February 2011
ATEK Medical July 2008 - September 2010
Medtronic 1991 - 2008
FMC 1984 - 1991
Skills
Software Quality..., Medical Devices, FDA, ISO 13485, Quality Systems, CAPA, Design Control, Quality System, Spreadsheet Validation, Software Validation, Supplier Quality, Medical Tourism, Medical Travel..., Design Assurance, Process Validation, Online Teaching, Manufacturing Quality, Japanese Culture, Quality Auditing, Quality Management, Contract Manufacturing, Manufacturing, Biomedical Engineering, ISO, DMAIC, V&V, Six Sigma, FMEA, SPC, Root Cause Analysis, Process Improvement, Testing, Quality Assurance, Quality Control, Continuous Improvement, ISO 14971, Lean Manufacturing, Validation, Iso 9000, Design of Experiments, 21 CFR Part 11, GMP, Change Control, Minitab, Process Simulation, Regulatory Affairs, 21 CFR, Software Documentation, Computer System..., CE marking
Education
University of Minnesota - Carlson School of Management
MBA, Finance & General Management
University of Minnesota-Twin Cities
BSEE, Microprocessor Design
France - French literature study in Nevers
None, International study in France
University of St. Thomas
HeartWare Inc April 2015 - Present
Biomet 3i May 2014 - February 2015
Smith & Nephew January 2014 - April 2014
Hospira August 2013 - December 2013
Terumo Medical January 2011 - August 2013
St. Jude Medical 2010 - February 2011
ATEK Medical July 2008 - September 2010
Medtronic 1991 - 2008
FMC 1984 - 1991
Skills
Software Quality..., Medical Devices, FDA, ISO 13485, Quality Systems, CAPA, Design Control, Quality System, Spreadsheet Validation, Software Validation, Supplier Quality, Medical Tourism, Medical Travel..., Design Assurance, Process Validation, Online Teaching, Manufacturing Quality, Japanese Culture, Quality Auditing, Quality Management, Contract Manufacturing, Manufacturing, Biomedical Engineering, ISO, DMAIC, V&V, Six Sigma, FMEA, SPC, Root Cause Analysis, Process Improvement, Testing, Quality Assurance, Quality Control, Continuous Improvement, ISO 14971, Lean Manufacturing, Validation, Iso 9000, Design of Experiments, 21 CFR Part 11, GMP, Change Control, Minitab, Process Simulation, Regulatory Affairs, 21 CFR, Software Documentation, Computer System..., CE marking
Education
University of Minnesota - Carlson School of Management
MBA, Finance & General Management
University of Minnesota-Twin Cities
BSEE, Microprocessor Design
France - French literature study in Nevers
None, International study in France
University of St. Thomas
Erin Driggers Erin Driggers's HeartWare Inc Experience November 2014 - Present
Job HeartWare Clinical Specialist
Industry Medical Devices
Experience
HeartWare Inc November 2014 - Present
Procirca January 2009 - November 2014
UPMC Artificial Heart Program November 2006 - November 2014
Skills
Medical Devices, Mechanical Circulatory..., Ventricular Assist...
Education
University of Pittsburgh 1999 — 2003
BS, Biomechanical Engineering
HeartWare Inc November 2014 - Present
Procirca January 2009 - November 2014
UPMC Artificial Heart Program November 2006 - November 2014
Skills
Medical Devices, Mechanical Circulatory..., Ventricular Assist...
Education
University of Pittsburgh 1999 — 2003
BS, Biomechanical Engineering
Milton Collazo's HeartWare Inc Experience October 2008 - December 2008
Job Principal at Engineering Validation Services, Inc.
Industry Mechanical or Industrial Engineering
Experience
Engineering Validation Services, Inc. October 2011 - Present
Medtronic November 2009 - October 2011
Hypermarcas S/A January 2009 - September 2009
HeartWare Inc October 2008 - December 2008
Beckman Coulter Inc. July 2007 - September 2008
Boston Scientific October 2006 - July 2007
Watson Laboratories November 2005 - October 2006
Cardinal Health July 2005 - November 2005
Linde Gas January 2005 - June 2005
Cordis January 2004 - December 2004
Skills
Validation, GMP, V&V, Manufacturing, Medical Devices, Project Management, Quality System, ISO 13485, FDA, Lean Manufacturing, Six Sigma, Design Control
Education
University of Puerto Rico-Mayaguez 1985 — 1989
Bachelor's in Science (BS), Mechanical Engineering (ME)
Colegio Marista, Manati, Puerto Rico
Engineering Validation Services, Inc. October 2011 - Present
Medtronic November 2009 - October 2011
Hypermarcas S/A January 2009 - September 2009
HeartWare Inc October 2008 - December 2008
Beckman Coulter Inc. July 2007 - September 2008
Boston Scientific October 2006 - July 2007
Watson Laboratories November 2005 - October 2006
Cardinal Health July 2005 - November 2005
Linde Gas January 2005 - June 2005
Cordis January 2004 - December 2004
Skills
Validation, GMP, V&V, Manufacturing, Medical Devices, Project Management, Quality System, ISO 13485, FDA, Lean Manufacturing, Six Sigma, Design Control
Education
University of Puerto Rico-Mayaguez 1985 — 1989
Bachelor's in Science (BS), Mechanical Engineering (ME)
Colegio Marista, Manati, Puerto Rico
Brian Kuhnley's HeartWare Inc Experience July 2014 - Present
Job Principal System Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc July 2014 - Present
Starkey Hearing Technologies April 2013 - July 2014
Apnex Medical Inc May 2007 - January 2013
Xiotech August 2000 - May 2007
Beckman Coulter February 1998 - August 2000
Pharma Target Inc January 1996 - November 1997
Guidant December 1985 - January 1996
Cardiac Pacemakers December 1985 - 1994
Honeywell Underseas Systems 1984 - December 1985
FMC Northern Ordinance Division 1978 - 1984
Education
University of Minnesota-Twin Cities 1976 — 1979
BSEE, Electronics
University of Minnesota Duluth 1975 — 1976
---, Pre-Engineering
HeartWare Inc July 2014 - Present
Starkey Hearing Technologies April 2013 - July 2014
Apnex Medical Inc May 2007 - January 2013
Xiotech August 2000 - May 2007
Beckman Coulter February 1998 - August 2000
Pharma Target Inc January 1996 - November 1997
Guidant December 1985 - January 1996
Cardiac Pacemakers December 1985 - 1994
Honeywell Underseas Systems 1984 - December 1985
FMC Northern Ordinance Division 1978 - 1984
Education
University of Minnesota-Twin Cities 1976 — 1979
BSEE, Electronics
University of Minnesota Duluth 1975 — 1976
---, Pre-Engineering
Michael Ruger's HeartWare Inc Experience January 2010 - Present
Job Director of North America Sales at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2010 - Present
Micrus Endovascular March 2008 - September 2010
Spectranetics 2006 - 2008
Medtronic 1999 - 2006
Johnson & Johnson 1988 - 1999
Education
University of Northern Colorado
Bachelor's Degree, Business Administration and Management, General
HeartWare Inc January 2010 - Present
Micrus Endovascular March 2008 - September 2010
Spectranetics 2006 - 2008
Medtronic 1999 - 2006
Johnson & Johnson 1988 - 1999
Education
University of Northern Colorado
Bachelor's Degree, Business Administration and Management, General
Rovina Salahuddin's HeartWare Inc Experience Senior Buyer/PlannerCordisApril 2006 - December 2007
Job Senior Buyer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc Senior Buyer/PlannerCordisApril 2006 - December 2007
Skills
Cross-functional Team..., Medical Devices, Strategic Sourcing, Purchasing, Supply Chain, Lean Manufacturing, ISO 13485, FDA, Quality System, Teamwork
Education
University of Phoenix 2003 — 2005
Master of Business Administration (MBA), Business Administration and Management, General
HeartWare Inc Senior Buyer/PlannerCordisApril 2006 - December 2007
Skills
Cross-functional Team..., Medical Devices, Strategic Sourcing, Purchasing, Supply Chain, Lean Manufacturing, ISO 13485, FDA, Quality System, Teamwork
Education
University of Phoenix 2003 — 2005
Master of Business Administration (MBA), Business Administration and Management, General
Nicholas Hiivala's HeartWare Inc Experience July 2015 - Present
Job Clinical education for Heartware
Industry Medical Devices
Experience
HeartWare Inc July 2015 - Present
University of Maryland Medical Center 2010 - July 2015
Skills
Medical Imaging, Biomedical Engineering, Data Analysis, Clinical Research, Medical Devices, Hospitals, Matlab, Healthcare, Research
Education
University of Minnesota-Twin Cities 2005 — 2008
B.S., Biomedical Engineering
HeartWare Inc July 2015 - Present
University of Maryland Medical Center 2010 - July 2015
Skills
Medical Imaging, Biomedical Engineering, Data Analysis, Clinical Research, Medical Devices, Hospitals, Matlab, Healthcare, Research
Education
University of Minnesota-Twin Cities 2005 — 2008
B.S., Biomedical Engineering
Donald Sandford's HeartWare Inc Experience August 2008 - March 2014
Job Product Development Consultant at Oxford International
Industry Medical Devices
Experience
Oxford International April 2014 - Present
HeartWare Inc August 2008 - March 2014
Cordis 2001 - 2003
Advanced Bionics 1999 - 2001
Cardiac Pacemakers Inc 1987 - 1995
3M 1986 - 1988
Skills
Design Control, Manufacturing, Biomedical Engineering, Product Development, ISO 13485, R&D, Medical Devices, Design of Experiments, CAPA, V&V, FDA, Validation, Design for Manufacturing, Medical Device R&D, Quality System, ISO 14971, FMEA, Catheters
Education
University of Minnesota-Twin Cities 1977 — 1981
BSME, Biomedical Engineering
Oxford International April 2014 - Present
HeartWare Inc August 2008 - March 2014
Cordis 2001 - 2003
Advanced Bionics 1999 - 2001
Cardiac Pacemakers Inc 1987 - 1995
3M 1986 - 1988
Skills
Design Control, Manufacturing, Biomedical Engineering, Product Development, ISO 13485, R&D, Medical Devices, Design of Experiments, CAPA, V&V, FDA, Validation, Design for Manufacturing, Medical Device R&D, Quality System, ISO 14971, FMEA, Catheters
Education
University of Minnesota-Twin Cities 1977 — 1981
BSME, Biomedical Engineering
Larry Knopf's HeartWare Inc Experience March 2011 - Present
Job SVP and General Counsel at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2011 - Present
Boston Scientific February 1993 - July 2010
Bingham McCutchen 1991 - 1993
Gaston Snow 1986 - 1991
Skills
Medical Devices, Venture Capital, Corporate Law, Intellectual Property, Mergers & Acquisitions, Strategic Planning, Start-ups, Due Diligence, FDA, Cross-functional Team..., Business Strategy, Entrepreneurship, Restructuring
Education
University of Michigan Law School 1983 — 1986
JD
University of Pennsylvania - The Wharton School 1979 — 1983
BSE, Accounting and Political Science
HeartWare Inc March 2011 - Present
Boston Scientific February 1993 - July 2010
Bingham McCutchen 1991 - 1993
Gaston Snow 1986 - 1991
Skills
Medical Devices, Venture Capital, Corporate Law, Intellectual Property, Mergers & Acquisitions, Strategic Planning, Start-ups, Due Diligence, FDA, Cross-functional Team..., Business Strategy, Entrepreneurship, Restructuring
Education
University of Michigan Law School 1983 — 1986
JD
University of Pennsylvania - The Wharton School 1979 — 1983
BSE, Accounting and Political Science
Matthew Saterbak's HeartWare Inc Experience September 2015 - Present
Job Senior Electrical Engineer at HeartWare Inc
Industry Electrical/Electronic Manufacturing
Experience
HeartWare Inc September 2015 - Present
Cardiovascular Systems, Inc. September 2014 - September 2015
Smiths Medical May 2013 - August 2014
Medtronic Inc. October 2011 - April 2013
Sauer-Danfoss June 2006 - October 2011
Skills
Electronics, Engineering, Electrical Engineering, Microcontrollers, Embedded Systems, Power Conversion, Motor Control, PCB design, Mixed Signal, Analog Circuit Design, Digital Signal..., Labview, Design of Experiments, Simulations, Medical Devices, FMEA, R&D, Design for Manufacturing, Matlab, C
Education
University of Minnesota-Twin Cities 2003 — 2007
BEE, Electrical Engineering, Political Science, Modern Dance
NDSU 2002 — 2003
Mechanical Engineering
HeartWare Inc September 2015 - Present
Cardiovascular Systems, Inc. September 2014 - September 2015
Smiths Medical May 2013 - August 2014
Medtronic Inc. October 2011 - April 2013
Sauer-Danfoss June 2006 - October 2011
Skills
Electronics, Engineering, Electrical Engineering, Microcontrollers, Embedded Systems, Power Conversion, Motor Control, PCB design, Mixed Signal, Analog Circuit Design, Digital Signal..., Labview, Design of Experiments, Simulations, Medical Devices, FMEA, R&D, Design for Manufacturing, Matlab, C
Education
University of Minnesota-Twin Cities 2003 — 2007
BEE, Electrical Engineering, Political Science, Modern Dance
NDSU 2002 — 2003
Mechanical Engineering
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY