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
David Neugaard David Neugaard's HeartWare Inc Experience May 2014 - October 2014
Job QA Compliance Administration
Industry Medical Devices
Mitch Falter Mitch Falter's HeartWare Inc Experience September 2013 - October 2014
Job Product Quality Engineer at HeartWare International
Industry Medical Devices
Experience
HeartWare International October 2014 - Present
HeartWare Inc September 2013 - October 2014
Miami Brain Endowment Bank June 2013 - September 2013
Bascom Palmer Eye Institute June 2012 - May 2013
Skills
Medical Devices, Sop, Clinical Research, Software Documentation, Quality Management, Product Development, Engineering, Quality Control, Biomedical Engineering, Design Control, ISO 13485, FDA, CAPA
Education
University of Miami 2009 — 2014
Master of Science (M.S.)/Bachelor of Science, Biomedical/Medical Engineering
HeartWare International October 2014 - Present
HeartWare Inc September 2013 - October 2014
Miami Brain Endowment Bank June 2013 - September 2013
Bascom Palmer Eye Institute June 2012 - May 2013
Skills
Medical Devices, Sop, Clinical Research, Software Documentation, Quality Management, Product Development, Engineering, Quality Control, Biomedical Engineering, Design Control, ISO 13485, FDA, CAPA
Education
University of Miami 2009 — 2014
Master of Science (M.S.)/Bachelor of Science, Biomedical/Medical Engineering
Sherrie Stutz-Lazzara Sherrie Stutz-Lazzara's HeartWare Inc Experience June 2013 - Present
Job Clinical Specialist at HeartWare Inc
Industry Medical Practice
Experience
HeartWare Inc June 2013 - Present
UPMC Presbyterian/Shadyside April 2012 - August 2012
Allegheny General Hospital July 2006 - November 2011
Allegheny General Hospital 2004 - July 2006
Arrow International 1998 - 2004
Skills
Healthcare, Hospitals, Nursing, Clinical, Critical Care, Cardiac Care, Heart Transplant, Mechanical Heart Assist, Health Education, Leadership, Operations Management, Medical Sales, Presenter, Presentation Development, Friendliness, Caring, Clinical Research, Cardiac, Acute Care, Inpatient, Surgery, ICU, Medical Devices, Epic Systems, Cardiology
Education
Robert Morris University 2006 — 2008
MSN, Nursing Administration
Carlow University 1999 — 2001
BSN, Nursing Science
St. Francis School of Nursing 1982 — 1985
Diploma in Nursing, Registered Nursing/Registered Nurse
HeartWare Inc June 2013 - Present
UPMC Presbyterian/Shadyside April 2012 - August 2012
Allegheny General Hospital July 2006 - November 2011
Allegheny General Hospital 2004 - July 2006
Arrow International 1998 - 2004
Skills
Healthcare, Hospitals, Nursing, Clinical, Critical Care, Cardiac Care, Heart Transplant, Mechanical Heart Assist, Health Education, Leadership, Operations Management, Medical Sales, Presenter, Presentation Development, Friendliness, Caring, Clinical Research, Cardiac, Acute Care, Inpatient, Surgery, ICU, Medical Devices, Epic Systems, Cardiology
Education
Robert Morris University 2006 — 2008
MSN, Nursing Administration
Carlow University 1999 — 2001
BSN, Nursing Science
St. Francis School of Nursing 1982 — 1985
Diploma in Nursing, Registered Nursing/Registered Nurse
Mallie Chery Mallie Chery's HeartWare Inc Experience Customer ServiceNYSE EuronextSeptember 2001 - November 2006
Job Customer Service at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc Customer ServiceNYSE EuronextSeptember 2001 - November 2006
Education
UC Santa Barbara
HeartWare Inc Customer ServiceNYSE EuronextSeptember 2001 - November 2006
Education
UC Santa Barbara
Nancy Arnold Nancy Arnold's HeartWare Inc Experience October 2013 - August 2014
Job Principal Consultant Nancy Arnold Consulting
Industry Medical Devices
Experience
Nancy Arnold Consulting August 2014 - Present
HeartWare Inc October 2013 - August 2014
Nancy Arnold Consulting LLC July 2012 - October 2013
Genzyme October 2011 - July 2012
Boston Scientific 2008 - October 2011
Haemonetics 2000 - 2008
American Red Cross 1998 - 2000
Hemasure December 1995 - December 1997
American Red Cross New England 1987 - 1995
Various Labs and Hospitals 1978 - 1988
Education
Northeastern University
MS, Health Science - Microbiology, Virology
University at Albany, SUNY
BS, Biology
Nancy Arnold Consulting August 2014 - Present
HeartWare Inc October 2013 - August 2014
Nancy Arnold Consulting LLC July 2012 - October 2013
Genzyme October 2011 - July 2012
Boston Scientific 2008 - October 2011
Haemonetics 2000 - 2008
American Red Cross 1998 - 2000
Hemasure December 1995 - December 1997
American Red Cross New England 1987 - 1995
Various Labs and Hospitals 1978 - 1988
Education
Northeastern University
MS, Health Science - Microbiology, Virology
University at Albany, SUNY
BS, Biology
Mark Strong Mark Strong's HeartWare Inc Experience July 2014 - Present
Job Senior Vice President at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc July 2014 - Present
HeartWare Inc September 2013 - July 2014
Boston Scientific June 2011 - August 2013
Boston Scientific November 2009 - June 2011
Boston Scientific 2006 - 2009
Guidant 2004 - 2006
Guidant 2002 - 2004
Guidant 2000 - 2002
Guidant 1999 - 2000
Guidant 1998 - 1999
Skills
FDA, Quality System, Design Control, Medical Devices, CAPA, ISO 13485, Design of Experiments, Biomedical Engineering, V&V, R&D, Validation, Cross-functional Team..., Testing, ISO, Process Engineering, Six Sigma, Clinical Trials, Systems Engineering, Quality Assurance, Strategic Leadership, Root Cause Problem..., Innovation, Strategic Vision, Product Development, Mobile Applications, Strong Business Acumen, Financial Analysis, Global Talent..., Talent Management, Mentoring Of Staff, Project Portfolio..., Customer Engagement, Cloud Computing, Competitive Analysis, Global Sourcing, Service Delivery, Collaborative Leadership, Operational Efficiency, Team Building, Business Strategy, Department Budgeting, Quality Management, Software Quality..., Design Research, Strategic Partnerships, Strategic Sourcing, Mergers & Acquisitions, Cardiology, System Verification, Team Leadership
Education
University of St. Thomas - Opus College of Business 1995 — 1998
MBA, Business
University of Minnesota-Twin Cities 1994 — 1997
MSEE, Semiconductor Design
North Dakota State University
BSEE, Electrical and Electronics Engineering
HeartWare Inc July 2014 - Present
HeartWare Inc September 2013 - July 2014
Boston Scientific June 2011 - August 2013
Boston Scientific November 2009 - June 2011
Boston Scientific 2006 - 2009
Guidant 2004 - 2006
Guidant 2002 - 2004
Guidant 2000 - 2002
Guidant 1999 - 2000
Guidant 1998 - 1999
Skills
FDA, Quality System, Design Control, Medical Devices, CAPA, ISO 13485, Design of Experiments, Biomedical Engineering, V&V, R&D, Validation, Cross-functional Team..., Testing, ISO, Process Engineering, Six Sigma, Clinical Trials, Systems Engineering, Quality Assurance, Strategic Leadership, Root Cause Problem..., Innovation, Strategic Vision, Product Development, Mobile Applications, Strong Business Acumen, Financial Analysis, Global Talent..., Talent Management, Mentoring Of Staff, Project Portfolio..., Customer Engagement, Cloud Computing, Competitive Analysis, Global Sourcing, Service Delivery, Collaborative Leadership, Operational Efficiency, Team Building, Business Strategy, Department Budgeting, Quality Management, Software Quality..., Design Research, Strategic Partnerships, Strategic Sourcing, Mergers & Acquisitions, Cardiology, System Verification, Team Leadership
Education
University of St. Thomas - Opus College of Business 1995 — 1998
MBA, Business
University of Minnesota-Twin Cities 1994 — 1997
MSEE, Semiconductor Design
North Dakota State University
BSEE, Electrical and Electronics Engineering
Elizabeth Brule's HeartWare Inc Experience September 2015 - Present
Job Product Manager, HeartWare
Industry Medical Devices
Experience
HeartWare Inc September 2015 - Present
Edwards Lifesciences January 2012 - August 2015
Edwards Lifesciences July 2010 - January 2012
Regeneron Pharmaceuticals May 2008 - August 2008
Skills
Cross-functional Team..., Medical Devices, Biomedical Engineering, R&D, Quality System, FDA, Minitab, Microsoft Office
Education
Rensselaer Polytechnic Institute 2006 — 2010
Bachelor of Science, Biomedical Engineering
HeartWare Inc September 2015 - Present
Edwards Lifesciences January 2012 - August 2015
Edwards Lifesciences July 2010 - January 2012
Regeneron Pharmaceuticals May 2008 - August 2008
Skills
Cross-functional Team..., Medical Devices, Biomedical Engineering, R&D, Quality System, FDA, Minitab, Microsoft Office
Education
Rensselaer Polytechnic Institute 2006 — 2010
Bachelor of Science, Biomedical Engineering
Carla Ouellette's HeartWare Inc Experience June 2014 - Present
Job Human Resource Associate at HeartWare Inc
Industry Human Resources
Experience
HeartWare Inc June 2014 - Present
The MathWorks May 2011 - May 2014
Micronet Mobile Technologies, Inc. January 2011 - April 2011
National Datacomputer January 2010 - January 2011
National Datacomputer September 2003 - January 2010
Skills
Onboarding, Corporate Recruiting, Talent Acquisition, Applicant Tracking..., Screening Resumes, HRIS, Human Resources, Interviews, Behavioral Interviewing, Accounts Receivable, Personnel Management, Internet Recruiting, Recruiting, Payroll, Temporary Placement, Accounts Payable, Taleo, Leadership, Training, Microsoft Office
Education
Lasell College 2009 — 2011
Masters, Human Resource Management
University of Massachusetts Boston 2003 — 2008
Bachelor's, Psychology
Waltham High
Waltham High
Waltham High
Waltham High School
HeartWare Inc June 2014 - Present
The MathWorks May 2011 - May 2014
Micronet Mobile Technologies, Inc. January 2011 - April 2011
National Datacomputer January 2010 - January 2011
National Datacomputer September 2003 - January 2010
Skills
Onboarding, Corporate Recruiting, Talent Acquisition, Applicant Tracking..., Screening Resumes, HRIS, Human Resources, Interviews, Behavioral Interviewing, Accounts Receivable, Personnel Management, Internet Recruiting, Recruiting, Payroll, Temporary Placement, Accounts Payable, Taleo, Leadership, Training, Microsoft Office
Education
Lasell College 2009 — 2011
Masters, Human Resource Management
University of Massachusetts Boston 2003 — 2008
Bachelor's, Psychology
Waltham High
Waltham High
Waltham High
Waltham High School
Hector Salvador Hector Salvador's HeartWare Inc Experience January 2014 - Present
Job Complain Handling Analyst at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2014 - Present
Cordis 2005 - January 2014
Skills
Microsoft Word, Microsoft Excel, Outlook, Microsoft Office, Claims Management, Problem Solving, Claims Resolution, Claim Investigation, Healthcare, Medical Devices, Quality System, Process Improvement, Clinical Research, FDA, Quality Assurance
Education
Miami Dade College
Associate's Degree, Biology/Biological Sciences, General
Coral Gables High
High School
HeartWare Inc January 2014 - Present
Cordis 2005 - January 2014
Skills
Microsoft Word, Microsoft Excel, Outlook, Microsoft Office, Claims Management, Problem Solving, Claims Resolution, Claim Investigation, Healthcare, Medical Devices, Quality System, Process Improvement, Clinical Research, FDA, Quality Assurance
Education
Miami Dade College
Associate's Degree, Biology/Biological Sciences, General
Coral Gables High
High School
Wilberto Torres-Ortiz's HeartWare Inc Experience June 2014 - Present
Job R&D Project Engineer Packaging
Industry Medical Devices
Experience
HeartWare Inc June 2014 - Present
McNeil Consumer Health with Equity Packaging, Inc. May 2012 - May 2014
Volimania November 2012 - April 2014
Volimania May 2008 - September 2012
Merck Sharp & Dome June 2004 - May 2012
Skills
Manufacturing, GMP, Quality System, Cross-functional Team..., FDA, Validation, Pharmaceutical Industry, Six Sigma, Product Development, Project Management, Lean Manufacturing, Change Control, Medical Devices, 21 CFR Part 11, SOP, Budget Management, ISO 9000, ISO 11607 Part 1 & 2, Pharmaceutical Packaging, Packaging Development, ISO 13485, Packaging
Education
University of Puerto Rico-Mayaguez 1999 — 2004
BS Mechanical Engineer
Universidad Politécnica de Puerto Rico
Project Management Methodology Course, Certificate of Completion
CROEM - Centro Residencial Oportunidades Educativas de Mayaguez 1997 — 1999
High School
HeartWare Inc June 2014 - Present
McNeil Consumer Health with Equity Packaging, Inc. May 2012 - May 2014
Volimania November 2012 - April 2014
Volimania May 2008 - September 2012
Merck Sharp & Dome June 2004 - May 2012
Skills
Manufacturing, GMP, Quality System, Cross-functional Team..., FDA, Validation, Pharmaceutical Industry, Six Sigma, Product Development, Project Management, Lean Manufacturing, Change Control, Medical Devices, 21 CFR Part 11, SOP, Budget Management, ISO 9000, ISO 11607 Part 1 & 2, Pharmaceutical Packaging, Packaging Development, ISO 13485, Packaging
Education
University of Puerto Rico-Mayaguez 1999 — 2004
BS Mechanical Engineer
Universidad Politécnica de Puerto Rico
Project Management Methodology Course, Certificate of Completion
CROEM - Centro Residencial Oportunidades Educativas de Mayaguez 1997 — 1999
High School
Eddy Segura Eddy Segura's HeartWare Inc Experience June 2014 - August 2014
Job Sr. Manufacturing Engineer at Codman a Johnson and Johnson Company
Industry Medical Devices
Experience
Codman Neurovascular - DePuySynthes - J&J August 2014 - Present
HeartWare Inc June 2014 - August 2014
Cordis Johnson & Johnson May 2014 - June 2014
International Medical Industries, Inc. February 2013 - May 2014
Aveva Drug Delivery Systems May 2006 - September 2012
Boston Scientific 2003 - 2006
Cordis Johnson & Johnson January 1996 - January 2003
French Fragrances January 1994 - January 1996
Skills
Validation, FDA, Quality System, Six Sigma, GMP, Manufacturing, V&V, R&D, FMEA, Design of Experiments, ISO, Product Development, Process Improvement, Software Documentation, Process Simulation, Quality Control, Troubleshooting, Management, Calibration, Training, Sop, Change Control, Design Control
Education
Polytechnic University 2003 — 2005
Bachelor’s Degree, Computer Science (BSCS), Polytechnic University, Miami Campus, FL,
ISPJAE - Havana, Cuba 1991 — 1994
Bachelor’s Degree, Electrical Engineering (BSEE) Equipment’s & Components, ISPJAE, Havana, Cuba
Codman Neurovascular - DePuySynthes - J&J August 2014 - Present
HeartWare Inc June 2014 - August 2014
Cordis Johnson & Johnson May 2014 - June 2014
International Medical Industries, Inc. February 2013 - May 2014
Aveva Drug Delivery Systems May 2006 - September 2012
Boston Scientific 2003 - 2006
Cordis Johnson & Johnson January 1996 - January 2003
French Fragrances January 1994 - January 1996
Skills
Validation, FDA, Quality System, Six Sigma, GMP, Manufacturing, V&V, R&D, FMEA, Design of Experiments, ISO, Product Development, Process Improvement, Software Documentation, Process Simulation, Quality Control, Troubleshooting, Management, Calibration, Training, Sop, Change Control, Design Control
Education
Polytechnic University 2003 — 2005
Bachelor’s Degree, Computer Science (BSCS), Polytechnic University, Miami Campus, FL,
ISPJAE - Havana, Cuba 1991 — 1994
Bachelor’s Degree, Electrical Engineering (BSEE) Equipment’s & Components, ISPJAE, Havana, Cuba
Ginger Dunn's HeartWare Inc Experience June 2013 - Present
Job Territory Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc June 2013 - Present
St. Jude Medical April 2010 - May 2013
Boyan Research Group May 2009 - December 2009
Wonalancet Textiles August 2004 - August 2008
Skills
Medical Devices, Operating Room
Education
Georgia Institute of Technology 2005 — 2009
B.S., Biomedical Engineering
HeartWare Inc June 2013 - Present
St. Jude Medical April 2010 - May 2013
Boyan Research Group May 2009 - December 2009
Wonalancet Textiles August 2004 - August 2008
Skills
Medical Devices, Operating Room
Education
Georgia Institute of Technology 2005 — 2009
B.S., Biomedical Engineering
Katherine Chorpenning Katherine Chorpenning's HeartWare Inc Experience April 2013 - Present
Job Clinical Research Associate at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc April 2013 - Present
HeartWare Inc July 2010 - April 2013
Penn State University 2005 - 2010
Kensey Nash Corporation June 2007 - August 2007
Skills
Biomedical Engineering, Clinical Research, Field Service..., Protocol Design, Minitab, Design Control, Biomaterials, Clinical Development, FDA, Medical Devices, Design of Experiments, R&D, V&V, Labview
Education
Penn State University 2008 — 2010
Master of Science, Bioengineering
Penn State University 2005 — 2010
Bachelor of Science, Bioengineering
HeartWare Inc April 2013 - Present
HeartWare Inc July 2010 - April 2013
Penn State University 2005 - 2010
Kensey Nash Corporation June 2007 - August 2007
Skills
Biomedical Engineering, Clinical Research, Field Service..., Protocol Design, Minitab, Design Control, Biomaterials, Clinical Development, FDA, Medical Devices, Design of Experiments, R&D, V&V, Labview
Education
Penn State University 2008 — 2010
Master of Science, Bioengineering
Penn State University 2005 — 2010
Bachelor of Science, Bioengineering
Christopher Michelena's HeartWare Inc Experience January 2015 - Present
Job Clinical Engineering Intern at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2015 - Present
University of Miami September 2014 - December 2014
University of Miami August 2012 - January 2014
Miami Project to Cure Paralysis August 2011 - July 2012
Nike November 2010 - August 2011
Skills
Biomedical Engineering, Labview, Tissue Culture, Microsoft Office, Matlab, Research, Laboratory, Biomaterials, AutoCAD, Data Analysis, NI LabVIEW, Signal Processing, Soldering, Pspice, Microsoft Excel, Bench Work, Cell Culture, Experimentation, Microscopy, Confocal Microscopy, Scientific Writing, Medical Research, Teamwork, Microsoft Word, Spanish, Computers, Electrical Engineering, Eagle PCB, Microelectronics, PowerPoint, Public Speaking, LabVIEW, Medical Devices, SolidWorks
Education
University of Miami 2014 — 2015
Master of Science (M.S.), Biomedical Engineering (Medical Devices)
University of Miami 2011 — 2015
Bachelor of Science (B.S.), Biomedical Engineering (Electrical Concentration), Senior
Miami Dade College 2009 — 2011
Biomedical/Medical Engineering
HeartWare Inc January 2015 - Present
University of Miami September 2014 - December 2014
University of Miami August 2012 - January 2014
Miami Project to Cure Paralysis August 2011 - July 2012
Nike November 2010 - August 2011
Skills
Biomedical Engineering, Labview, Tissue Culture, Microsoft Office, Matlab, Research, Laboratory, Biomaterials, AutoCAD, Data Analysis, NI LabVIEW, Signal Processing, Soldering, Pspice, Microsoft Excel, Bench Work, Cell Culture, Experimentation, Microscopy, Confocal Microscopy, Scientific Writing, Medical Research, Teamwork, Microsoft Word, Spanish, Computers, Electrical Engineering, Eagle PCB, Microelectronics, PowerPoint, Public Speaking, LabVIEW, Medical Devices, SolidWorks
Education
University of Miami 2014 — 2015
Master of Science (M.S.), Biomedical Engineering (Medical Devices)
University of Miami 2011 — 2015
Bachelor of Science (B.S.), Biomedical Engineering (Electrical Concentration), Senior
Miami Dade College 2009 — 2011
Biomedical/Medical Engineering
James Photis James Photis's HeartWare Inc Experience December 2013 - March 2014
Job Independent Consultant at JPDevelopment
Industry Electrical/Electronic Manufacturing
Experience
BAE Systems December 2014 - April 2015
HeartWare Inc December 2013 - March 2014
Philips Lifeline July 2013 - October 2013
United Electronic Industries January 2011 - December 2011
iRobot November 2009 - December 2010
Analog Devices January 2003 - December 2008
MKS Instruments January 2002 - December 2002
Nortel January 2001 - December 2001
Polaroid January 1980 - December 2000
Skills
Labview, Visual C++, Electrical, Electronics, Test Engineering, Semiconductors, Electricians, Device Drivers, Testing, ASIC, PCB design, USB, FPGA, Embedded Systems, R&D, Hardware, Manufacturing, Systems Engineering, Test Equipment, Integration, Engineering Management, Root Cause Analysis, Engineering, I2C, Automation, Sensors, Analog, Simulations, IC, Electrical Engineering, Embedded Software, Digital Signal..., Robotics, Mixed Signal, Verilog, RF, Failure Analysis, Circuit Design, Design of Experiments, Analog Circuit Design, Design for Manufacturing, Optics, SPC, GPIB, Data Acquisition, Medical Devices, SPI, Firmware, RS232, Validation
Education
Northeastern University
BSCE, Computer Engineering
Northeastern University
Associate's Degree, Electrical Engineering
BAE Systems December 2014 - April 2015
HeartWare Inc December 2013 - March 2014
Philips Lifeline July 2013 - October 2013
United Electronic Industries January 2011 - December 2011
iRobot November 2009 - December 2010
Analog Devices January 2003 - December 2008
MKS Instruments January 2002 - December 2002
Nortel January 2001 - December 2001
Polaroid January 1980 - December 2000
Skills
Labview, Visual C++, Electrical, Electronics, Test Engineering, Semiconductors, Electricians, Device Drivers, Testing, ASIC, PCB design, USB, FPGA, Embedded Systems, R&D, Hardware, Manufacturing, Systems Engineering, Test Equipment, Integration, Engineering Management, Root Cause Analysis, Engineering, I2C, Automation, Sensors, Analog, Simulations, IC, Electrical Engineering, Embedded Software, Digital Signal..., Robotics, Mixed Signal, Verilog, RF, Failure Analysis, Circuit Design, Design of Experiments, Analog Circuit Design, Design for Manufacturing, Optics, SPC, GPIB, Data Acquisition, Medical Devices, SPI, Firmware, RS232, Validation
Education
Northeastern University
BSCE, Computer Engineering
Northeastern University
Associate's Degree, Electrical Engineering
Alfredo Garcell Alfredo Garcell's HeartWare Inc Experience November 2005 - Present
Job Mechanical Designer at HeartWare Inc
Industry Mechanical or Industrial Engineering
Experience
Alymar Designs Inc. 2010 - Present
HeartWare Inc November 2005 - Present
Beckman Coulter June 1999 - November 2005
Rally Mfg 1999 - 2000
Mark 2 Engineering 1999 - 1999
Advanced Electronics 1998 - 1998
American Express 1997 - 1998
Coulter Corp. June 1989 - June 1996
Skills
Solidworks, Pro/Engineer, Product Development, CAD, Medical Devices, Engineering, Microsoft Office, GD&T, Inventory Management, Problem Solving, Documentation, Production, FDA, ISO, Team Building, Continuous Improvement, Quality Systems, Troubleshooting, Validation, Excel, Word, PowerPoint, Photoshop, Design for Manufacturing, Design Control, Assembly, Illustrator, Microsoft Word, Quality System, Manufacturing, Pro Engineer, Design of Experiments, FMEA, Quality Assurance, Product Design, Process Improvement, Machining, Software Documentation, Testing, ISO 13485, R&D, SolidWorks
Education
Miami Dade College 1988 — 1990
Architecture
Southwest Miami Senior High 1985 — 1988
Diploma, Architecture
PTC - Beckman Coulter
Wildfire 2, Intralink, Pro-Engineer
MLEC
Alymar Designs Inc. 2010 - Present
HeartWare Inc November 2005 - Present
Beckman Coulter June 1999 - November 2005
Rally Mfg 1999 - 2000
Mark 2 Engineering 1999 - 1999
Advanced Electronics 1998 - 1998
American Express 1997 - 1998
Coulter Corp. June 1989 - June 1996
Skills
Solidworks, Pro/Engineer, Product Development, CAD, Medical Devices, Engineering, Microsoft Office, GD&T, Inventory Management, Problem Solving, Documentation, Production, FDA, ISO, Team Building, Continuous Improvement, Quality Systems, Troubleshooting, Validation, Excel, Word, PowerPoint, Photoshop, Design for Manufacturing, Design Control, Assembly, Illustrator, Microsoft Word, Quality System, Manufacturing, Pro Engineer, Design of Experiments, FMEA, Quality Assurance, Product Design, Process Improvement, Machining, Software Documentation, Testing, ISO 13485, R&D, SolidWorks
Education
Miami Dade College 1988 — 1990
Architecture
Southwest Miami Senior High 1985 — 1988
Diploma, Architecture
PTC - Beckman Coulter
Wildfire 2, Intralink, Pro-Engineer
MLEC
Patricia Rivera Patricia Rivera's HeartWare Inc Experience October 2011 - January 2014
Job Sr Process Development Engineer at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical February 2014 - Present
HeartWare Inc October 2011 - January 2014
Boston Scientific 2001 - 2011
Boston Scientific 2001 - 2008
Education
Universidad Nacional de Colombia 1990 — 1995
Bolton Medical February 2014 - Present
HeartWare Inc October 2011 - January 2014
Boston Scientific 2001 - 2011
Boston Scientific 2001 - 2008
Education
Universidad Nacional de Colombia 1990 — 1995
Irina Shishko's HeartWare Inc Experience June 2015 - Present
Job Sr. Systems Engineer, QA Lead at HeartWare Inc
Industry Hospital & Health Care
Experience
HeartWare Inc June 2015 - Present
Siemens Healthcare January 2007 - March 2015
BAYER HEALTHCARE O&I-NORTH AMERICA January 2003 - January 2007
ABBOTT September 1999 - January 2003
Skills
Medical Devices, Product Management, ISO 13485, Minitab, Design Control, Agile Methodologies, Quality System, Root Cause Analysis, R&D, Validation, FDA, Labview, Software Engineering, Testing, Product Launch, Product Development, CAPA, Automation, Quality Assurance, Process Simulation
Education
University of Massachusetts Lowell 1996 — 1999
BS, Computer Sience
HeartWare Inc June 2015 - Present
Siemens Healthcare January 2007 - March 2015
BAYER HEALTHCARE O&I-NORTH AMERICA January 2003 - January 2007
ABBOTT September 1999 - January 2003
Skills
Medical Devices, Product Management, ISO 13485, Minitab, Design Control, Agile Methodologies, Quality System, Root Cause Analysis, R&D, Validation, FDA, Labview, Software Engineering, Testing, Product Launch, Product Development, CAPA, Automation, Quality Assurance, Process Simulation
Education
University of Massachusetts Lowell 1996 — 1999
BS, Computer Sience
Ellen Garven Ellen Garven's HeartWare Inc Experience June 2014 - Present
Job Algorithm Engineer at HeartWare Inc
Industry Research
Experience
HeartWare Inc June 2014 - Present
Tufts University January 2011 - May 2014
Tufts University September 2013 - December 2013
Agios Pharmaceuticals June 2013 - August 2013
Skills
Matlab, Data Analysis, Microsoft Excel, C++, LaTeX, Statistics, Spectroscopy, FTIR, UV/Vis, SDS-PAGE, Raman Microscopy, Mathematical Modeling, Physics, Mathematica, Research, Microscopy
Education
Tufts University 2010 — 2014
B.S., Physics, Mathematics
HeartWare Inc June 2014 - Present
Tufts University January 2011 - May 2014
Tufts University September 2013 - December 2013
Agios Pharmaceuticals June 2013 - August 2013
Skills
Matlab, Data Analysis, Microsoft Excel, C++, LaTeX, Statistics, Spectroscopy, FTIR, UV/Vis, SDS-PAGE, Raman Microscopy, Mathematical Modeling, Physics, Mathematica, Research, Microscopy
Education
Tufts University 2010 — 2014
B.S., Physics, Mathematics
Michael Spens Michael Spens's HeartWare Inc Experience July 2013 - December 2013
Job Northeastern University '14
Industry Research
Experience
Radiation Monitoring Devices, Inc. March 2015 - Present
HeartWare Inc July 2013 - December 2013
Northeastern University Action Lab May 2012 - December 2012
Skills
Testing, Matlab, Labview, Process Improvement, Research, Hardware, Statistics, Biomedical Engineering, Data Analysis, R&D
Education
Northeastern University 2010 — 2014
Bachelor of Science (BS), Physics and Philosophy
Radiation Monitoring Devices, Inc. March 2015 - Present
HeartWare Inc July 2013 - December 2013
Northeastern University Action Lab May 2012 - December 2012
Skills
Testing, Matlab, Labview, Process Improvement, Research, Hardware, Statistics, Biomedical Engineering, Data Analysis, R&D
Education
Northeastern University 2010 — 2014
Bachelor of Science (BS), Physics and Philosophy
David First David First's HeartWare Inc Experience June 2015 - Present
Job Experienced Organizational Development Professional
Industry Human Resources
Experience
HeartWare Inc June 2015 - Present
TripAdvisor December 2012 - June 2015
Suffolk Construction 2004 - 2012
Tabor Academy 1996 - 2003
Skills
Leadership Development, Strategic Planning, Team Building, Talent Management, Instructional Design, Organizational...
Education
Union College
BA, Economics & Mathematics
Union College
MAT, Mathematics
HeartWare Inc June 2015 - Present
TripAdvisor December 2012 - June 2015
Suffolk Construction 2004 - 2012
Tabor Academy 1996 - 2003
Skills
Leadership Development, Strategic Planning, Team Building, Talent Management, Instructional Design, Organizational...
Education
Union College
BA, Economics & Mathematics
Union College
MAT, Mathematics
Jane Reedy Jane Reedy's HeartWare Inc Experience May 2005 - January 2008
Job ConsultantBayRock Medtech Advisors
Industry Medical Devices
Experience
BayRock Medtech Advisors January 2008 - Present
HeartWare Inc May 2005 - January 2008
Medical Device Companies March 2003 - May 2005
Thoratec 1999 - March 2003
Thoratec 1998 - 1999
Thoratec 1996 - 1999
Thoratec 1993 - 1996
Skills
Medical Devices, Market Development, Clinical Trials, Product Development, Start-ups, Operating Room, Market Research, Biomedical Engineering, Biotechnology, Product Launch, Clinical Research, Business Planning, FDA, Commercialization, ISO 13485, Competitive Analysis, Cardiology, R&D, Lifesciences, Cross-functional Team..., Regulatory Affairs, Clinical Development, Validation, Quality System
Education
Saint Louis University
Master of Science in Nursing
University of Missouri-Columbia
Bachelor of Science in Nursing
BayRock Medtech Advisors January 2008 - Present
HeartWare Inc May 2005 - January 2008
Medical Device Companies March 2003 - May 2005
Thoratec 1999 - March 2003
Thoratec 1998 - 1999
Thoratec 1996 - 1999
Thoratec 1993 - 1996
Skills
Medical Devices, Market Development, Clinical Trials, Product Development, Start-ups, Operating Room, Market Research, Biomedical Engineering, Biotechnology, Product Launch, Clinical Research, Business Planning, FDA, Commercialization, ISO 13485, Competitive Analysis, Cardiology, R&D, Lifesciences, Cross-functional Team..., Regulatory Affairs, Clinical Development, Validation, Quality System
Education
Saint Louis University
Master of Science in Nursing
University of Missouri-Columbia
Bachelor of Science in Nursing
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
Erika Mand, PHR, CIR's HeartWare Inc Experience December 2014 - Present
Job Corporate Recruiter at HeartWare Inc
Industry Human Resources
Experience
HeartWare Inc December 2014 - Present
Jackson Health System July 2013 - November 2014
JB Poindexter Inc February 2013 - June 2013
Cheniere Energy, Inc. June 2012 - December 2012
Tyco International (now Pentair) April 2011 - June 2012
Insperity (formerly Administaff) July 2010 - April 2011
TAPFIN Process Solutions, A COMSYS Company (now a Manpower company) January 2010 - July 2010
Burnett Accounting Specialists October 2006 - February 2009
PGA TOUR 2006 - 2006
Compressor Engineering Corporation 2004 - 2006
Skills
Talent Acquisition, Sourcing, Executive Search, Recruiting, Onboarding, Benefits Negotiation, Talent Management, Human Resources, Interviews, College Recruiting, Job Descriptions, Contract Recruitment, Deferred Compensation, Applicant Tracking..., Personnel Management, Hiring, Contract Negotiation, Internet Recruiting, Strategic Sourcing, Technical Recruiting, Staffing Services, Job Fairs, Screening Resumes, Taleo, Cold Calling, Employee Relations, Screening, Behavioral Interviewing, Temporary Staffing, Permanent Placement, Employer Branding, Full-life Cycle..., Networking, Workforce Planning, Boolean Searching, Passive Candidate..., Corporate Recruiting, Recruitment Advertising, Background Checks, AIRS trained, Social Recruiting, HRIS, Closing Candidates, Resume Writing, Direct Hires, Union Labor, Healthcare, Local Government, Temporary Placement, New Hire Orientations
Education
University of Minnesota-Twin Cities 1995 — 1997
BA French, Language and Literature
University of Wisconsin-Eau Claire 1993 — 1995
English, French
LP Goodrich High School 1990 — 1993
Rice University
PHR Review
HeartWare Inc December 2014 - Present
Jackson Health System July 2013 - November 2014
JB Poindexter Inc February 2013 - June 2013
Cheniere Energy, Inc. June 2012 - December 2012
Tyco International (now Pentair) April 2011 - June 2012
Insperity (formerly Administaff) July 2010 - April 2011
TAPFIN Process Solutions, A COMSYS Company (now a Manpower company) January 2010 - July 2010
Burnett Accounting Specialists October 2006 - February 2009
PGA TOUR 2006 - 2006
Compressor Engineering Corporation 2004 - 2006
Skills
Talent Acquisition, Sourcing, Executive Search, Recruiting, Onboarding, Benefits Negotiation, Talent Management, Human Resources, Interviews, College Recruiting, Job Descriptions, Contract Recruitment, Deferred Compensation, Applicant Tracking..., Personnel Management, Hiring, Contract Negotiation, Internet Recruiting, Strategic Sourcing, Technical Recruiting, Staffing Services, Job Fairs, Screening Resumes, Taleo, Cold Calling, Employee Relations, Screening, Behavioral Interviewing, Temporary Staffing, Permanent Placement, Employer Branding, Full-life Cycle..., Networking, Workforce Planning, Boolean Searching, Passive Candidate..., Corporate Recruiting, Recruitment Advertising, Background Checks, AIRS trained, Social Recruiting, HRIS, Closing Candidates, Resume Writing, Direct Hires, Union Labor, Healthcare, Local Government, Temporary Placement, New Hire Orientations
Education
University of Minnesota-Twin Cities 1995 — 1997
BA French, Language and Literature
University of Wisconsin-Eau Claire 1993 — 1995
English, French
LP Goodrich High School 1990 — 1993
Rice University
PHR Review
Damian Lynch Damian Lynch's HeartWare Inc Experience September 2014 - Present
Job Marketing, Education & Sales, Strategy Executive
Industry Medical Devices
Experience
HeartWare Inc September 2014 - Present
Abiomed 2013 - 2014
Boston Scientific 2011 - 2013
Boston Scientific 2003 - 2011
Eli Lilly 2001 - 2003
Bureau of Alcohol, Tobacco and Firearms (ATF) 1998 - 2001
Skills
Cardiology, Interventional..., Electrophysiology, Medical Devices, Surgeons, Market Development, Product Launch, Operating Room, Training, Skills Training, Sales Management, Strategy, Hands-on Training, Clinical Trials, Cardiac Rhythm..., Cath Lab, Pacemakers, Peripheral Intervention, Structural Heart, Intelligence, Investigation, Analysis, Business Strategy, Training Delivery, Medical Education, Marketing, Pharmaceutical Industry, Fellowships, KOL Identification, KOL development, Commercialization, Contract Negotiation, Global Strategy, Building Relationships, Relationship Management, Pharmaceutical Sales, Vascular Surgery, Surgery, Key Opinion Leaders, Medical Sales, Catheters, Regulatory Affairs, Competitive Analysis, Heart Failure, Social Media, Social Media Measurement, Cross-functional Team..., Atrial Fibrillation, Healthcare Reimbursement, Data Analysis
Education
Georgetown University 1991 — 1995
BA, Psychology/Government
The University of Connecticut
Master of Business Administration (M.B.A.), In Progress
HeartWare Inc September 2014 - Present
Abiomed 2013 - 2014
Boston Scientific 2011 - 2013
Boston Scientific 2003 - 2011
Eli Lilly 2001 - 2003
Bureau of Alcohol, Tobacco and Firearms (ATF) 1998 - 2001
Skills
Cardiology, Interventional..., Electrophysiology, Medical Devices, Surgeons, Market Development, Product Launch, Operating Room, Training, Skills Training, Sales Management, Strategy, Hands-on Training, Clinical Trials, Cardiac Rhythm..., Cath Lab, Pacemakers, Peripheral Intervention, Structural Heart, Intelligence, Investigation, Analysis, Business Strategy, Training Delivery, Medical Education, Marketing, Pharmaceutical Industry, Fellowships, KOL Identification, KOL development, Commercialization, Contract Negotiation, Global Strategy, Building Relationships, Relationship Management, Pharmaceutical Sales, Vascular Surgery, Surgery, Key Opinion Leaders, Medical Sales, Catheters, Regulatory Affairs, Competitive Analysis, Heart Failure, Social Media, Social Media Measurement, Cross-functional Team..., Atrial Fibrillation, Healthcare Reimbursement, Data Analysis
Education
Georgetown University 1991 — 1995
BA, Psychology/Government
The University of Connecticut
Master of Business Administration (M.B.A.), In Progress
Lawrence Mulholland Lawrence Mulholland's HeartWare Inc Experience January 2009 - Present
Job Senior Manufacturing Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2009 - Present
Eaton Corporation January 2006 - November 2008
MAKO Surgical Corp. January 2008 - October 2008
Caterpillar Inc. 1992 - 2001
Skills
FDA, Manufacturing, Quality Assurance, Design for Manufacturing, Six Sigma Black Belt, CNC Programming, CMM, Lean Manufacturing, Cross-functional Team...
Education
Illinois Central College 2005 — 2007
CADC, Drud and Alcholhol Abuse Conseling, N/A
Iowa State University 1984 — 1988
BS Manufacturing and Industrial Engineering, Manufacturing Systems, minors in Math and Chemistry
Illinois Institute of Technology 1982 — 1984
AA Chemical Engineering Technician, Chemistry and Metalurgical Thermodynamics
HeartWare Inc January 2009 - Present
Eaton Corporation January 2006 - November 2008
MAKO Surgical Corp. January 2008 - October 2008
Caterpillar Inc. 1992 - 2001
Skills
FDA, Manufacturing, Quality Assurance, Design for Manufacturing, Six Sigma Black Belt, CNC Programming, CMM, Lean Manufacturing, Cross-functional Team...
Education
Illinois Central College 2005 — 2007
CADC, Drud and Alcholhol Abuse Conseling, N/A
Iowa State University 1984 — 1988
BS Manufacturing and Industrial Engineering, Manufacturing Systems, minors in Math and Chemistry
Illinois Institute of Technology 1982 — 1984
AA Chemical Engineering Technician, Chemistry and Metalurgical Thermodynamics
Lena Carpenter MT(ASCP), MBA Lena Carpenter MT(ASCP), MBA's HeartWare Inc Experience January 2014 - March 2015
Job Independent Clinical Research Professional
Industry Research
Experience
GW Pharmaceuticals April 2015 - Present
Carpenter Consulting Corporation 2000 - Present
Walter Reed Army Institute of Research July 2014 - March 2015
Remedy Pharmaceuticals, Inc. January 2014 - March 2015
HeartWare Inc January 2014 - March 2015
UTSW Zale Lipshy January 2013 - March 2015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) January 2013 - March 2015
National Institute of Neurological Disorders and Stroke (NINDS) January 2004 - March 2015
Monitorforhire.com January 2002 - March 2015
AstraZeneca October 2014 - January 2015
Skills
Neurology, Oncology, Infectious Diseases, Hematology, Cardiology, General Surgery, Ophthalmology, Orthopedics, Vaccines, Urology, Immunology, Pediatrics, Clinical Trials, Pharmaceuticals, Clinical Research, Regulatory Affairs, Clinical Trial..., EDC, Medical Devices, Surgery, GCP, Clinical Monitoring, Diabetes, Biotechnology, Asthma, Therapeutic areas, Pulmonology, Pharmaceutical Industry
Education
The Ohio State University
BS, MBA, Allied Health Professions and Business
GW Pharmaceuticals April 2015 - Present
Carpenter Consulting Corporation 2000 - Present
Walter Reed Army Institute of Research July 2014 - March 2015
Remedy Pharmaceuticals, Inc. January 2014 - March 2015
HeartWare Inc January 2014 - March 2015
UTSW Zale Lipshy January 2013 - March 2015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) January 2013 - March 2015
National Institute of Neurological Disorders and Stroke (NINDS) January 2004 - March 2015
Monitorforhire.com January 2002 - March 2015
AstraZeneca October 2014 - January 2015
Skills
Neurology, Oncology, Infectious Diseases, Hematology, Cardiology, General Surgery, Ophthalmology, Orthopedics, Vaccines, Urology, Immunology, Pediatrics, Clinical Trials, Pharmaceuticals, Clinical Research, Regulatory Affairs, Clinical Trial..., EDC, Medical Devices, Surgery, GCP, Clinical Monitoring, Diabetes, Biotechnology, Asthma, Therapeutic areas, Pulmonology, Pharmaceutical Industry
Education
The Ohio State University
BS, MBA, Allied Health Professions and Business
Pat Gahan Pat Gahan's HeartWare Inc Experience December 2014 - Present
Job Director of Marketing at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc December 2014 - Present
Aptus Endosystems April 2012 - October 2014
Novartis Vaccines and Diagnostics October 2009 - March 2012
Boston Scientific 2007 - 2009
Boston Scientific 2005 - 2007
Boston Scientific 2004 - 2005
Boston Scientific 2000 - 2004
Boston Scientific 1999 - 2000
Boston Scientific 1998 - 1999
Boston Scientific 1993 - 1998
Skills
Medical Devices, Strategic Planning, P&L Management, Leadership, International Sales, Contract Negotiation, Market Development, Recruiting, Sales, Cross-functional Team..., Product Development, Operating Room, Capital Equipment, Cardiology, Product Launch, Strategy, Sales Operations, Commercialization, Hardware Diagnostics, Start-ups, Urology, Surgeons, Interventional..., Marketing
Education
Pennsylvania State University 1985 — 1989
Bachelor of Science, Pre-Medicine
HeartWare Inc December 2014 - Present
Aptus Endosystems April 2012 - October 2014
Novartis Vaccines and Diagnostics October 2009 - March 2012
Boston Scientific 2007 - 2009
Boston Scientific 2005 - 2007
Boston Scientific 2004 - 2005
Boston Scientific 2000 - 2004
Boston Scientific 1999 - 2000
Boston Scientific 1998 - 1999
Boston Scientific 1993 - 1998
Skills
Medical Devices, Strategic Planning, P&L Management, Leadership, International Sales, Contract Negotiation, Market Development, Recruiting, Sales, Cross-functional Team..., Product Development, Operating Room, Capital Equipment, Cardiology, Product Launch, Strategy, Sales Operations, Commercialization, Hardware Diagnostics, Start-ups, Urology, Surgeons, Interventional..., Marketing
Education
Pennsylvania State University 1985 — 1989
Bachelor of Science, Pre-Medicine
Roberto Quirindongo Roberto Quirindongo's HeartWare Inc Experience April 2011 - Present
Job Quality Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc April 2011 - Present
BD August 2010 - March 2011
Boston Scientific August 2008 - August 2010
Pall Life Sciences March 2006 - August 2008
Ivax Pharmaceuticals June 2004 - January 2006
Skills
V&V, Engineering, Validation, Quality Assurance, Medical Devices, Quality System, ISO 13485, Change Control, Design Control, FDA, CAPA, Visio, Design of Experiments, Minitab, GMP, 21 CFR Part 11, Sop, Root Cause Analysis, ISO, Six Sigma, Quality Auditing, Manufacturing, Computer System..., Continuous Improvement, 21 CFR, DMAIC, Lean Manufacturing, ISO 14971, Gage R&R, CQE, FDA GMP, SPC
Education
Universidad de Puerto Rico 1996 — 2002
Bachelor of Science, Industrial Engineering
HeartWare Inc April 2011 - Present
BD August 2010 - March 2011
Boston Scientific August 2008 - August 2010
Pall Life Sciences March 2006 - August 2008
Ivax Pharmaceuticals June 2004 - January 2006
Skills
V&V, Engineering, Validation, Quality Assurance, Medical Devices, Quality System, ISO 13485, Change Control, Design Control, FDA, CAPA, Visio, Design of Experiments, Minitab, GMP, 21 CFR Part 11, Sop, Root Cause Analysis, ISO, Six Sigma, Quality Auditing, Manufacturing, Computer System..., Continuous Improvement, 21 CFR, DMAIC, Lean Manufacturing, ISO 14971, Gage R&R, CQE, FDA GMP, SPC
Education
Universidad de Puerto Rico 1996 — 2002
Bachelor of Science, Industrial Engineering
Stephen Dodd's HeartWare Inc Experience August 2011 - February 2013
Job Contract Software Engineer at Raytheon
Industry Medical Devices
Experience
Rocket Gaming Systems September 2015 - Present
Raytheon March 2015 - June 2015
Abbott May 2013 - July 2014
HeartWare Inc August 2011 - February 2013
Thales Communications June 2010 - December 2010
Telephonics Corporation November 2002 - March 2010
M.I.T Lincoln Laboratory 1990 - 2002
Apollo Computer 1987 - 1988
Skills
Design Patterns, Project Management, Risk Assessment, C++, Embedded Systems, C, Software Engineering, VxWorks, Embedded Software, Object Oriented Design, Software Development, XML, Debugging, UML, Unix, Visual Studio, Perl, Testing, ClearCase
Education
New York University - Polytechnic School of Engineering 2007 — 2011
MSCS, Computer Science
University of Massachusetts Lowell 1987 — 1990
BSCS cum Laude', Computer Science
University of New Hampshire
Rocket Gaming Systems September 2015 - Present
Raytheon March 2015 - June 2015
Abbott May 2013 - July 2014
HeartWare Inc August 2011 - February 2013
Thales Communications June 2010 - December 2010
Telephonics Corporation November 2002 - March 2010
M.I.T Lincoln Laboratory 1990 - 2002
Apollo Computer 1987 - 1988
Skills
Design Patterns, Project Management, Risk Assessment, C++, Embedded Systems, C, Software Engineering, VxWorks, Embedded Software, Object Oriented Design, Software Development, XML, Debugging, UML, Unix, Visual Studio, Perl, Testing, ClearCase
Education
New York University - Polytechnic School of Engineering 2007 — 2011
MSCS, Computer Science
University of Massachusetts Lowell 1987 — 1990
BSCS cum Laude', Computer Science
University of New Hampshire
Pablo Bleyer's HeartWare Inc Experience March 2006 - March 2012
Job Embedded Systems Engineer
Industry Semiconductors
Experience
Consultant April 2012 - Present
GEM Paver Systems September 2012 - Present
Neocis Inc. January 2013 - August 2013
HeartWare, Inc March 2006 - March 2012
GEM Paver Systems February 2006 - June 2007
Embedded CL S.A. December 2000 - March 2005
AMT S.A. January 1999 - November 2000
Association of Universities for Research in Astronomy (AURA) January 1998 - December 1998
Department of Geophysics (DGF), University of Chile March 1997 - April 1998
Centro de Electrónica Aplicada (CEAP) March 1996 - April 1997
Skills
Embedded Systems, Firmware, Microcontrollers, Digital Signal..., FPGA, PCB design, Device Drivers, C++, Linux, Analog Circuit Design, USB, Verilog, ARM, Hardware Architecture, I2C, Python, Manufacturing, RTOS, Simulink, Subversion, Medical Devices, C, SPI, Electronic Circuit..., Qt, ISO 13485, Altium Designer, LabVIEW, Matlab, Sensors, Analog, Integrated Circuit..., Xilinx, Microprocessors, SoC, Ethernet, ISO 14971, Motor Control, uClinux, Assembly, Digital Design, IEC 60601, IEC 62304, Control System Design, Bluetooth, IOT
Education
Universidad de Chile 1997 — 2002
BS level equivalent
Universidad de Chile 1994 — 1997
School of Engineering Common Plan
Consultant April 2012 - Present
GEM Paver Systems September 2012 - Present
Neocis Inc. January 2013 - August 2013
HeartWare, Inc March 2006 - March 2012
GEM Paver Systems February 2006 - June 2007
Embedded CL S.A. December 2000 - March 2005
AMT S.A. January 1999 - November 2000
Association of Universities for Research in Astronomy (AURA) January 1998 - December 1998
Department of Geophysics (DGF), University of Chile March 1997 - April 1998
Centro de Electrónica Aplicada (CEAP) March 1996 - April 1997
Skills
Embedded Systems, Firmware, Microcontrollers, Digital Signal..., FPGA, PCB design, Device Drivers, C++, Linux, Analog Circuit Design, USB, Verilog, ARM, Hardware Architecture, I2C, Python, Manufacturing, RTOS, Simulink, Subversion, Medical Devices, C, SPI, Electronic Circuit..., Qt, ISO 13485, Altium Designer, LabVIEW, Matlab, Sensors, Analog, Integrated Circuit..., Xilinx, Microprocessors, SoC, Ethernet, ISO 14971, Motor Control, uClinux, Assembly, Digital Design, IEC 60601, IEC 62304, Control System Design, Bluetooth, IOT
Education
Universidad de Chile 1997 — 2002
BS level equivalent
Universidad de Chile 1994 — 1997
School of Engineering Common Plan
Jeff McMahan's HeartWare Inc Experience June 2015 - Present
Job Test Engineering Intern at HeartWare Inc
Industry Biotechnology
Experience
HeartWare Inc June 2015 - Present
University of Miami - Department of Physics January 2014 - Present
University of Miami School of Business Administration May 2015 - August 2015
Varsity Tutors April 2014 - August 2014
University of Miami Athletic Department August 2013 - April 2014
Skills
Molecular Biology, Laboratory, Cell Culture, Fluorescence Microscopy, Gel Electrophoresis, PCR Primer Design, Bacterial Transformation, Matlab, C++, Biotechnology, Gas Chromatography, Microsoft Office, Biochemistry, Teamwork, Fundraising, Microsoft Word, PowerPoint, Microsoft Excel, Public Speaking, Statistics, Time Management, SolidWorks, LabVIEW, Python
Education
University of Miami 2012 — 2016
Bachelor of Science (B.S.), Double Major in Biomedical Engineering and Applied Physics, 3.928
International Academy of Macomb 2008 — 2012
International Baccalaureate Diploma, 3.972
HeartWare Inc June 2015 - Present
University of Miami - Department of Physics January 2014 - Present
University of Miami School of Business Administration May 2015 - August 2015
Varsity Tutors April 2014 - August 2014
University of Miami Athletic Department August 2013 - April 2014
Skills
Molecular Biology, Laboratory, Cell Culture, Fluorescence Microscopy, Gel Electrophoresis, PCR Primer Design, Bacterial Transformation, Matlab, C++, Biotechnology, Gas Chromatography, Microsoft Office, Biochemistry, Teamwork, Fundraising, Microsoft Word, PowerPoint, Microsoft Excel, Public Speaking, Statistics, Time Management, SolidWorks, LabVIEW, Python
Education
University of Miami 2012 — 2016
Bachelor of Science (B.S.), Double Major in Biomedical Engineering and Applied Physics, 3.928
International Academy of Macomb 2008 — 2012
International Baccalaureate Diploma, 3.972
Jacob Adams's HeartWare Inc Experience July 2015 - Present
Job Product Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc July 2015 - Present
HeartWare Inc November 2013 - Present
Barnes-Jewish Hospital: Washington University May 2012 - November 2013
University of Kentucky Medical Center May 2010 - May 2012
Skills
Critical Care, Nursing, ECMO, Critical Care Medicine, Critical Thinking, Patient Safety, Cardiology, Nursing Education, ACLS, BLS, IABP, Heart Failure, Ventricular Assist..., Clinical Expertise, Medical Devices, LVAD, Open Heart Surgery, Cardiothoracic Surgery, Patient Monitoring, Critical Analysis, Medication..., Medication Therapy..., Transplantation, Clinical Education, Patient Education, Patient Advocacy, Policy/Procedure..., Policy Analysis, Teamwork, TNCC, Critical Care Transport, Heart Transplant, Lung Transplantation, Heart Valves, EKG
Education
University of Kentucky 2006 — 2010
BSN, Nursing
HeartWare Inc July 2015 - Present
HeartWare Inc November 2013 - Present
Barnes-Jewish Hospital: Washington University May 2012 - November 2013
University of Kentucky Medical Center May 2010 - May 2012
Skills
Critical Care, Nursing, ECMO, Critical Care Medicine, Critical Thinking, Patient Safety, Cardiology, Nursing Education, ACLS, BLS, IABP, Heart Failure, Ventricular Assist..., Clinical Expertise, Medical Devices, LVAD, Open Heart Surgery, Cardiothoracic Surgery, Patient Monitoring, Critical Analysis, Medication..., Medication Therapy..., Transplantation, Clinical Education, Patient Education, Patient Advocacy, Policy/Procedure..., Policy Analysis, Teamwork, TNCC, Critical Care Transport, Heart Transplant, Lung Transplantation, Heart Valves, EKG
Education
University of Kentucky 2006 — 2010
BSN, Nursing
Barry Lovern Barry Lovern's HeartWare Inc Experience Account ManagerSorin GroupOctober 2006 - February 2013
Job Territory Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc Account ManagerSorin GroupOctober 2006 - February 2013
SurgRx August 2005 - October 2006
RITA Medical Systems October 2000 - August 2005
Pharmacia Corporation June 1999 - October 2000
Skills
Operating Room, Medical Devices, Urology, Market Development, Vascular, Sales, Product Launch, Sales Operations, Capital Equipment, Cardiology, Surgeons, Disposables, Surgery, Surgical Instruments
Education
Kennesaw State University 1990 — 1994
Bachelor of Business Administration, Business Management
HeartWare Inc Account ManagerSorin GroupOctober 2006 - February 2013
SurgRx August 2005 - October 2006
RITA Medical Systems October 2000 - August 2005
Pharmacia Corporation June 1999 - October 2000
Skills
Operating Room, Medical Devices, Urology, Market Development, Vascular, Sales, Product Launch, Sales Operations, Capital Equipment, Cardiology, Surgeons, Disposables, Surgery, Surgical Instruments
Education
Kennesaw State University 1990 — 1994
Bachelor of Business Administration, Business Management
Amy Tavolario's HeartWare Inc Experience March 2013 - Present
Job Territory Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2013 - Present
Baxter Biosurgery January 2012 - March 2013
Baxter Biosurgery February 2009 - January 2012
Arrow International/Teleflex Medical 2005 - February 2009
Dermik Laboratories/Sanofi-Aventis 2000 - 2005
Skills
Cardiothoracic Surgery, Vascular Surgery, General Surgery, Operating Room, Vascular, Urology, Capital Equipment, Surgeons, Surgical Instruments, Orthopedic, Cardiology, Cardiac Surgery, Interventional Radiology, Interventional..., Disposables, Sales Force Development, Selling, Medical Sales, Pharmaceutical Sales, Neurosurgery, Sales Operations, Market Development, Cath Lab, Operating Room Sales, Capital Equipment Sales, Product Launch, Sales
Education
Point Park University
BS, Marketing and Public Relations
HeartWare Inc March 2013 - Present
Baxter Biosurgery January 2012 - March 2013
Baxter Biosurgery February 2009 - January 2012
Arrow International/Teleflex Medical 2005 - February 2009
Dermik Laboratories/Sanofi-Aventis 2000 - 2005
Skills
Cardiothoracic Surgery, Vascular Surgery, General Surgery, Operating Room, Vascular, Urology, Capital Equipment, Surgeons, Surgical Instruments, Orthopedic, Cardiology, Cardiac Surgery, Interventional Radiology, Interventional..., Disposables, Sales Force Development, Selling, Medical Sales, Pharmaceutical Sales, Neurosurgery, Sales Operations, Market Development, Cath Lab, Operating Room Sales, Capital Equipment Sales, Product Launch, Sales
Education
Point Park University
BS, Marketing and Public Relations
Jie qin Jie qin's HeartWare Inc Experience September 2013 - Present
Job Senior Statistical Programmer at HeartWare Inc
Industry Biotechnology
Experience
HeartWare Inc September 2013 - Present
Boston Biomedical Associates February 2013 - July 2013
HCRI October 2010 - January 2013
Sanofi Pasteur August 2009 - August 2011
TIMI Study Group March 2006 - July 2009
Skills
SAS, CDISC, Biostatistics, SAS programming, Clinical Trials
Education
The Ohio State University 2004 — 2006
Master, Applied Statistics
UMass Boston 2001 — 2005
Bachelor's degree, Computer Science
HeartWare Inc September 2013 - Present
Boston Biomedical Associates February 2013 - July 2013
HCRI October 2010 - January 2013
Sanofi Pasteur August 2009 - August 2011
TIMI Study Group March 2006 - July 2009
Skills
SAS, CDISC, Biostatistics, SAS programming, Clinical Trials
Education
The Ohio State University 2004 — 2006
Master, Applied Statistics
UMass Boston 2001 — 2005
Bachelor's degree, Computer Science
Erika Schaefer's HeartWare Inc Experience June 2012 - August 2012
Job Public Relations and Media Specialist
Industry Public Relations and Communications
Experience
Freelance March 2015 - Present
Allen Media Strategies May 2014 - Present
Beer Institute October 2013 - May 2014
Blue Ribbon BBQ March 2009 - January 2014
Admissions College of Education and Human Development February 2013 - May 2013
HeartWare Inc June 2012 - August 2012
MIT January 2008 - January 2010
CCHS Theatre 2006 - 2010
Skills
Social Media, Editing, Event Planning, Film, Public Speaking, Theatre, Facebook, Creative Writing, Blogging, Advertising, Film Production, Customer Service, Public Relations, Stand-up Comedy, Crowd Sourcing/ Funding, Study Abroad, Writing, Blogger, Social Networking, Press Releases
Education
George Mason University 2010 — 2014
Bachelor of Arts (BA), Communication and Media Studies, Cum Laude
Concord Carlisle High School
Freelance March 2015 - Present
Allen Media Strategies May 2014 - Present
Beer Institute October 2013 - May 2014
Blue Ribbon BBQ March 2009 - January 2014
Admissions College of Education and Human Development February 2013 - May 2013
HeartWare Inc June 2012 - August 2012
MIT January 2008 - January 2010
CCHS Theatre 2006 - 2010
Skills
Social Media, Editing, Event Planning, Film, Public Speaking, Theatre, Facebook, Creative Writing, Blogging, Advertising, Film Production, Customer Service, Public Relations, Stand-up Comedy, Crowd Sourcing/ Funding, Study Abroad, Writing, Blogger, Social Networking, Press Releases
Education
George Mason University 2010 — 2014
Bachelor of Arts (BA), Communication and Media Studies, Cum Laude
Concord Carlisle High School
Lina Alzate, M.D. Lina Alzate, M.D.'s HeartWare Inc Experience June 2013 - December 2014
Job Sr. Director Safety Operations at Johnson & Johnson, Medical Devices
Industry Medical Devices
Experience
Johnson & Johnson May 2015 - Present
Clinical Safety/ Risk Management January 2015 - Present
HeartWare Inc June 2013 - December 2014
Johnson & Johnson, Cardiovascular Franchise – Cordis & Biosense Webster December 2012 - June 2013
Johnson & Johnson, Cordis June 2010 - June 2013
Medtronic, Neuromodulation February 2008 - June 2010
Medtronic, CRDM February 2005 - February 2008
Medtronic, CRDM August 2003 - February 2005
Clinica Medellín, Unidad Cardiovascular May 1997 - December 2000
Clinica Medellín, Intensive Care Unit 1999 - 2000
Skills
Medical Devices, FDA, ISO 13485, CAPA, Cross-functional Team..., Quality System, Clinical Trials, Design Control, Biomedical Engineering, Clinical Research, Cardiology, ISO 14971, GCP, Product Safety, Validation, Complaint Management, Regulatory Affairs, Interventional..., 21 CFR Part 11, FMEA, Process Improvement, Presentation Skills, Heart Failure, Electrophysiology, Adult Education, Curriculum Design, Field Training, Technical Training, Adverse Event Reporting, Post Market Surveillance, Regulatory Reporting, Annual Reports, Clinical Evaluation..., Risk Assessment, Risk Management, Health Hazard Evaluation, Recalls, Procedure Development, SOP Development, People Management, Team Development, Management Review, Performance Metrics
Education
University of Minnesota-Twin Cities 2001 — 2003
MS
Universidad Pontificia Bolivariana 1989 — 1996
MD
Johnson & Johnson May 2015 - Present
Clinical Safety/ Risk Management January 2015 - Present
HeartWare Inc June 2013 - December 2014
Johnson & Johnson, Cardiovascular Franchise – Cordis & Biosense Webster December 2012 - June 2013
Johnson & Johnson, Cordis June 2010 - June 2013
Medtronic, Neuromodulation February 2008 - June 2010
Medtronic, CRDM February 2005 - February 2008
Medtronic, CRDM August 2003 - February 2005
Clinica Medellín, Unidad Cardiovascular May 1997 - December 2000
Clinica Medellín, Intensive Care Unit 1999 - 2000
Skills
Medical Devices, FDA, ISO 13485, CAPA, Cross-functional Team..., Quality System, Clinical Trials, Design Control, Biomedical Engineering, Clinical Research, Cardiology, ISO 14971, GCP, Product Safety, Validation, Complaint Management, Regulatory Affairs, Interventional..., 21 CFR Part 11, FMEA, Process Improvement, Presentation Skills, Heart Failure, Electrophysiology, Adult Education, Curriculum Design, Field Training, Technical Training, Adverse Event Reporting, Post Market Surveillance, Regulatory Reporting, Annual Reports, Clinical Evaluation..., Risk Assessment, Risk Management, Health Hazard Evaluation, Recalls, Procedure Development, SOP Development, People Management, Team Development, Management Review, Performance Metrics
Education
University of Minnesota-Twin Cities 2001 — 2003
MS
Universidad Pontificia Bolivariana 1989 — 1996
MD
Allison Chan Allison Chan's HeartWare Inc Experience 2010 - 2010
Job Regulatory Affairs Specialist at Smith & Nephew Orthopaedics
Industry Medical Devices
Experience
Smith & Nephew June 2015 - Present
Smith & Nephew Orthopaedics March 2014 - June 2015
St. Jude Medical March 2012 - February 2014
Georgia Institute of Technology August 2010 - December 2011
Georgia Institute of Technology January 2008 - December 2011
FDA July 2011 - August 2011
HeartWare Inc 2010 - 2010
Skills
Solidworks, Simulink, PowerPoint, Excel, Matlab, Word, Statistics, FDA, Biomedical Engineering, Clinical Research, Regulatory Affairs, SolidWorks, Biomaterials, Microsoft Word, R
Education
Georgia Institute of Technology 2007 — 2011
B.S, Biomedical Engineering
Smith & Nephew June 2015 - Present
Smith & Nephew Orthopaedics March 2014 - June 2015
St. Jude Medical March 2012 - February 2014
Georgia Institute of Technology August 2010 - December 2011
Georgia Institute of Technology January 2008 - December 2011
FDA July 2011 - August 2011
HeartWare Inc 2010 - 2010
Skills
Solidworks, Simulink, PowerPoint, Excel, Matlab, Word, Statistics, FDA, Biomedical Engineering, Clinical Research, Regulatory Affairs, SolidWorks, Biomaterials, Microsoft Word, R
Education
Georgia Institute of Technology 2007 — 2011
B.S, Biomedical Engineering
Frank Carneiro Frank Carneiro's HeartWare Inc Experience September 2014 - Present
Job Senior Programming Analyst at HeartWare Inc
Industry Computer Software
Experience
HeartWare Inc September 2014 - Present
PerkinElmer October 2012 - September 2014
Applied Materials March 2007 - October 2012
Brooks Automation June 2000 - March 2007
Source for Automation January 1997 - May 2000
Skills
Semiconductors, C#, Automation, .NET, Software Development, Engineering Management, Manufacturing, Testing, Cross-functional Team..., MES, Software Engineering, ClearCase, Integration, Delegation, ASP.NET
Education
Northeastern University 2000 — 2006
BA Science, Managing Information Systems
Newbury College 1997 — 2000
Associate, Computer Programming
Johnson and Wales University 1991 — 1993
Bachelor of Business Administration (BBA), Management
Milford High Schhol 1988 — 1991
HeartWare Inc September 2014 - Present
PerkinElmer October 2012 - September 2014
Applied Materials March 2007 - October 2012
Brooks Automation June 2000 - March 2007
Source for Automation January 1997 - May 2000
Skills
Semiconductors, C#, Automation, .NET, Software Development, Engineering Management, Manufacturing, Testing, Cross-functional Team..., MES, Software Engineering, ClearCase, Integration, Delegation, ASP.NET
Education
Northeastern University 2000 — 2006
BA Science, Managing Information Systems
Newbury College 1997 — 2000
Associate, Computer Programming
Johnson and Wales University 1991 — 1993
Bachelor of Business Administration (BBA), Management
Milford High Schhol 1988 — 1991
Javier Echenique's HeartWare Inc Experience March 2014 - Present
Job Product Manager at HeartWare
Industry Medical Devices
Experience
HeartWare Inc March 2014 - Present
Volcano Corporation July 2013 - March 2014
SynapDx June 2012 - June 2013
Medtronic - Cardiac Rhythm Disease Management June 2010 - August 2011
Medtronic - Cardiac Rhythm Disease Management June 2005 - August 2010
Skills
Marketing, Process Engineering, Research, Customer Service, Functional Requirements, Medical Devices, Cross-functional Team..., Product Development, Business Strategy, Analysis, Clinical Research, Manufacturing, Data Analysis, Entrepreneurship
Education
Harvard Business School 2011 — 2013
MBA, Business Administration and Management, General
Massachusetts Institute of Technology 2005 — 2007
Master of Science (M.S.), Health Sciences and Technology (HST), Mechanical Engineering
Massachusetts Institute of Technology 2001 — 2005
Bachelor of Science, Mechanical Engineering, Mechanical Engineering, Biomedical Engineering, Spanish
Belen Jesuit Preparatory School 1994 — 2001
High school diploma, Regular/General High School/Secondary Diploma Program
HeartWare Inc March 2014 - Present
Volcano Corporation July 2013 - March 2014
SynapDx June 2012 - June 2013
Medtronic - Cardiac Rhythm Disease Management June 2010 - August 2011
Medtronic - Cardiac Rhythm Disease Management June 2005 - August 2010
Skills
Marketing, Process Engineering, Research, Customer Service, Functional Requirements, Medical Devices, Cross-functional Team..., Product Development, Business Strategy, Analysis, Clinical Research, Manufacturing, Data Analysis, Entrepreneurship
Education
Harvard Business School 2011 — 2013
MBA, Business Administration and Management, General
Massachusetts Institute of Technology 2005 — 2007
Master of Science (M.S.), Health Sciences and Technology (HST), Mechanical Engineering
Massachusetts Institute of Technology 2001 — 2005
Bachelor of Science, Mechanical Engineering, Mechanical Engineering, Biomedical Engineering, Spanish
Belen Jesuit Preparatory School 1994 — 2001
High school diploma, Regular/General High School/Secondary Diploma Program
Amina Abdal Amina Abdal's HeartWare Inc Experience May 2010 - August 2010
Job Regulatory Affairs Specialist at Microaire Surgical Instruments
Industry Medical Devices
Experience
Microaire Surgical Instruments October 2014 - Present
Medtronic February 2014 - September 2014
Medtronic Spine & Biologics May 2012 - February 2014
Medtronic Spine & Biologics August 2010 - May 2012
HeartWare Inc May 2010 - August 2010
Biomet 3i March 2007 - August 2009
Cordis January 2006 - October 2006
GCI Biotech August 2005 - December 2005
Skills
Medical Devices, Biomedical Engineering, Design Control, FDA, R&D, Quality Assurance, Product Development, Biomaterials, Quality System, Regulatory Affairs, Spine, Product Launch, ISO 14971, CE marking, Orthopedic, Manufacturing, ISO, High Organizational..., Creative Problem Solving, Strategic Planning, International..., Microsoft Excel, GMP, Project Management, Design History Files..., Middle East & Africa..., PMA, Biomechanics, Design Verification..., Gage R, Technical Files, Biocompatibility, Orthopedics
Education
The University of Memphis 2010 — 2012
Medical Management MBA
University of Miami 2001 — 2005
BS, Biomedical Engineering
Microaire Surgical Instruments October 2014 - Present
Medtronic February 2014 - September 2014
Medtronic Spine & Biologics May 2012 - February 2014
Medtronic Spine & Biologics August 2010 - May 2012
HeartWare Inc May 2010 - August 2010
Biomet 3i March 2007 - August 2009
Cordis January 2006 - October 2006
GCI Biotech August 2005 - December 2005
Skills
Medical Devices, Biomedical Engineering, Design Control, FDA, R&D, Quality Assurance, Product Development, Biomaterials, Quality System, Regulatory Affairs, Spine, Product Launch, ISO 14971, CE marking, Orthopedic, Manufacturing, ISO, High Organizational..., Creative Problem Solving, Strategic Planning, International..., Microsoft Excel, GMP, Project Management, Design History Files..., Middle East & Africa..., PMA, Biomechanics, Design Verification..., Gage R, Technical Files, Biocompatibility, Orthopedics
Education
The University of Memphis 2010 — 2012
Medical Management MBA
University of Miami 2001 — 2005
BS, Biomedical Engineering
Scott Orr's HeartWare Inc Experience December 2014 - Present
Job
Industry Medical Devices
Experience
HeartWare Inc December 2014 - Present
Johnson & Johnson December 2011 - December 2014
Smiths Medical October 2009 - November 2011
Covidien July 2006 - September 2009
Covidien January 2005 - July 2006
Covidien August 2001 - January 2005
Covidien July 2000 - August 2001
Covidien November 1998 - July 2000
Wallace Computer Services May 1996 - November 1998
Skills
Market Development, Product Launch, Medical Devices, Capital Equipment, Product Development, Marketing, Sales, Sales Operations, Operating Room, Management, Surgeons, Surgical Instruments, Leadership, Global Marketing, Commercialization, Urology, Orthopedic
Education
Ithaca College 1992 — 1996
B.S.
HeartWare Inc December 2014 - Present
Johnson & Johnson December 2011 - December 2014
Smiths Medical October 2009 - November 2011
Covidien July 2006 - September 2009
Covidien January 2005 - July 2006
Covidien August 2001 - January 2005
Covidien July 2000 - August 2001
Covidien November 1998 - July 2000
Wallace Computer Services May 1996 - November 1998
Skills
Market Development, Product Launch, Medical Devices, Capital Equipment, Product Development, Marketing, Sales, Sales Operations, Operating Room, Management, Surgeons, Surgical Instruments, Leadership, Global Marketing, Commercialization, Urology, Orthopedic
Education
Ithaca College 1992 — 1996
B.S.
Demetria Gould Demetria Gould's HeartWare Inc Experience June 2013 - Present
Job Heartware Inc.
Industry Medical Devices
Experience
HeartWare Inc June 2013 - Present
Boston Scientific March 2011 - February 2012
Boston Scientific January 2010 - March 2011
Boston Scientific January 2003 - January 2010
Skills
Team Leadership, Communicate Effectively, Solution-oriented, Medical Devices, GMP, Quality Assurance, Documentation, CAPA, Lean Manufacturing, Software Documentation, Six Sigma, ISO 13485, FMEA, Manufacturing, Validation, FDA, Quality System, Quality Auditing, V&V, Sop, SAP
Education
Polytechnic University of Puerto Rico-Miami Campus 2007 — 2012
Bachelor in Science, Organizational Mangement
Miami Central Senior High 1988 — 1991
High School Diploma, General Education
HeartWare Inc June 2013 - Present
Boston Scientific March 2011 - February 2012
Boston Scientific January 2010 - March 2011
Boston Scientific January 2003 - January 2010
Skills
Team Leadership, Communicate Effectively, Solution-oriented, Medical Devices, GMP, Quality Assurance, Documentation, CAPA, Lean Manufacturing, Software Documentation, Six Sigma, ISO 13485, FMEA, Manufacturing, Validation, FDA, Quality System, Quality Auditing, V&V, Sop, SAP
Education
Polytechnic University of Puerto Rico-Miami Campus 2007 — 2012
Bachelor in Science, Organizational Mangement
Miami Central Senior High 1988 — 1991
High School Diploma, General Education
Kimberlee Guitar Kimberlee Guitar's HeartWare Inc Experience March 2013 - Present
Job Manager, Packaging Engineering at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2013 - Present
MAKO Surgical Corp. 2012 - 2013
Boston Scientific 2006 - 2012
Beckman Coulter 1997 - 2006
Ciba Self-Medication, Inc. 1996 - 1997
Rhône-Poulenc Rorer Pharmaceuticals, Inc. 1995 - 1996
Skills
Risk Management, Project Management, Quality Management, Quality Control, Validation, Cross-functional Team..., Change Management, CAPA, ISO 13485, FMEA, Design Control, FDA, Medical Devices, V&V, Quality System, Lean Manufacturing, ISO 14971, GMP
Education
Michigan State University 1991 — 1995
BS, Package Engineering
HeartWare Inc March 2013 - Present
MAKO Surgical Corp. 2012 - 2013
Boston Scientific 2006 - 2012
Beckman Coulter 1997 - 2006
Ciba Self-Medication, Inc. 1996 - 1997
Rhône-Poulenc Rorer Pharmaceuticals, Inc. 1995 - 1996
Skills
Risk Management, Project Management, Quality Management, Quality Control, Validation, Cross-functional Team..., Change Management, CAPA, ISO 13485, FMEA, Design Control, FDA, Medical Devices, V&V, Quality System, Lean Manufacturing, ISO 14971, GMP
Education
Michigan State University 1991 — 1995
BS, Package Engineering
Daniel Burkhoff Daniel Burkhoff's HeartWare Inc Experience March 2014 - Present
Job Founder at PVLoops
Industry Medical Devices
Experience
HeartWare Inc March 2014 - Present
PVLoops September 2012 - Present
Columbia University 2005 - Present
Impulse Dynamics December 2003 - June 2014
CircuLite, Inc. 2009 - December 2013
Cheetah Medical Inc. 2006 - January 2012
Skirball Center for Cardiovascular Research / Cardiovascular Foundation September 2004 - October 2005
Columbia University Medical Center July 1992 - December 2003
Skills
Heart Failure, Biomedical Engineering, Clinical Research, Medical Devices, Medical Education, Clinical Trials, Clinical Development, Cardiology, Surgery, Medicine, FDA, Medical Research, Cell Biology, Commercialization, Hardware Diagnostics, Animal Models, Pharmacology, Biotechnology, Translational Research, Interventional..., Medical Imaging, Pharmaceutical Industry, Cardiovascular Disease, Healthcare, Lifesciences, Hospitals, Molecular Biology, Internal Medicine, Vascular, Critical Care, Electrophysiology, Echocardiography, R&D, Life Sciences
Education
The Johns Hopkins University School of Medicine 1979 — 1987
Doctor of Medicine, Medicine
The Johns Hopkins University School of Medicine 1979 — 1987
PhD, Biomedical Engineering
Cornell University 1976 — 1979
BS, Applied and Engineering Physics
HeartWare Inc March 2014 - Present
PVLoops September 2012 - Present
Columbia University 2005 - Present
Impulse Dynamics December 2003 - June 2014
CircuLite, Inc. 2009 - December 2013
Cheetah Medical Inc. 2006 - January 2012
Skirball Center for Cardiovascular Research / Cardiovascular Foundation September 2004 - October 2005
Columbia University Medical Center July 1992 - December 2003
Skills
Heart Failure, Biomedical Engineering, Clinical Research, Medical Devices, Medical Education, Clinical Trials, Clinical Development, Cardiology, Surgery, Medicine, FDA, Medical Research, Cell Biology, Commercialization, Hardware Diagnostics, Animal Models, Pharmacology, Biotechnology, Translational Research, Interventional..., Medical Imaging, Pharmaceutical Industry, Cardiovascular Disease, Healthcare, Lifesciences, Hospitals, Molecular Biology, Internal Medicine, Vascular, Critical Care, Electrophysiology, Echocardiography, R&D, Life Sciences
Education
The Johns Hopkins University School of Medicine 1979 — 1987
Doctor of Medicine, Medicine
The Johns Hopkins University School of Medicine 1979 — 1987
PhD, Biomedical Engineering
Cornell University 1976 — 1979
BS, Applied and Engineering Physics
Daniel Christodoss Daniel Christodoss's HeartWare Inc Experience March 2011 - March 2012
Job Principal Manufacturing Engineer at Medtronic Vascular
Industry Medical Devices
Experience
Medtronic Vascular August 2015 - Present
Phillips-Medisize January 2015 - August 2015
Philips Respironics September 2014 - January 2015
Terumo Cardiovascular Systems May 2014 - September 2014
MAETRICS March 2014 - May 2014
Zimmer Trauma September 2013 - March 2014
Helix Medical LLC March 2012 - September 2013
HeartWare Inc March 2011 - March 2012
Nipro Diagnostics Inc December 2004 - March 2011
Eli Lilly and Company May 2003 - December 2004
Skills
Engineering, Process Simulation, Manufacturing, Product Development, Lean Manufacturing, SPC, Process Improvement, Six Sigma, Medical Devices, Design Control, Validation, Design of Experiments, Automation, CAD, FDA, ISO 13485, Quality System, R&D, Cross-functional Team..., FMEA
Education
University of Madras
Bachelor of Engineering, Mechanical Engineering
Medtronic Vascular August 2015 - Present
Phillips-Medisize January 2015 - August 2015
Philips Respironics September 2014 - January 2015
Terumo Cardiovascular Systems May 2014 - September 2014
MAETRICS March 2014 - May 2014
Zimmer Trauma September 2013 - March 2014
Helix Medical LLC March 2012 - September 2013
HeartWare Inc March 2011 - March 2012
Nipro Diagnostics Inc December 2004 - March 2011
Eli Lilly and Company May 2003 - December 2004
Skills
Engineering, Process Simulation, Manufacturing, Product Development, Lean Manufacturing, SPC, Process Improvement, Six Sigma, Medical Devices, Design Control, Validation, Design of Experiments, Automation, CAD, FDA, ISO 13485, Quality System, R&D, Cross-functional Team..., FMEA
Education
University of Madras
Bachelor of Engineering, Mechanical Engineering
Ahmad Ghaffari (Hosseini) Ahmad Ghaffari (Hosseini)'s HeartWare Inc Experience July 2011 - Present
Job Quality Engineer at HeartWare Inc.
Industry Medical Devices
Experience
HeartWare Inc. July 2011 - Present
Stellar Microelectronics September 2009 - March 2011
Boston scientific January 2005 - March 2009
Harman-Becker Automotive Systems; Northridge, CA March 1994 - December 2004
Ketema Aerospace & Electronics; El Cajon, CA January 1992 - February 1994
Skills
Manufacturing, Root Cause Analysis, Quality System, Testing, Process Improvement, Medical Devices, Engineering, Program Management, Validation, Visio, Quality Management, Troubleshooting, CAPA, FDA, Aerospace, Failure Analysis, Six Sigma, Lean Manufacturing, Electronics, Analysis
Education
Iowa State University 1969 — 1974
BS, EE
NROTC Program ISU. 1969 — 1974
Certification, NROTC
HeartWare Inc. July 2011 - Present
Stellar Microelectronics September 2009 - March 2011
Boston scientific January 2005 - March 2009
Harman-Becker Automotive Systems; Northridge, CA March 1994 - December 2004
Ketema Aerospace & Electronics; El Cajon, CA January 1992 - February 1994
Skills
Manufacturing, Root Cause Analysis, Quality System, Testing, Process Improvement, Medical Devices, Engineering, Program Management, Validation, Visio, Quality Management, Troubleshooting, CAPA, FDA, Aerospace, Failure Analysis, Six Sigma, Lean Manufacturing, Electronics, Analysis
Education
Iowa State University 1969 — 1974
BS, EE
NROTC Program ISU. 1969 — 1974
Certification, NROTC
William Williamson 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.)
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.)
Mike Moratz Mike Moratz's HeartWare Inc Experience February 2014 - Present
Job Market Access and Health Policy
Industry Medical Devices
Experience
HeartWare Inc February 2014 - Present
Janssen Diagnostics, LLC April 2012 - February 2014
Ethicon Endo-Surgery November 2008 - April 2012
Publicis Managed Markets September 2006 - October 2008
NPS 2006 - 2006
Merck & Co., Inc. 1983 - 2006
Skills
Medicaid, Managed Care, Hospitals, Healthcare, Medical Devices, Medical Diagnostics, Medicare, Advocate Development, Oncology, Health Care Systems, Health Economics, Employer Groups, Cross-functional Team..., Pharmaceutical Sales, Product Launch, Cardiology, Pharmaceutical Industry, Health Policy, Healthcare Industry, Sales Effectiveness, Market Development, Urology, Diabetes, Neurology, Endocrinology, Gastroenterology, Market Access, Infectious Diseases, Management
Education
IMS
University of Illinois Springfield
MA
University of Wisconsin-Milwaukee
BA
HeartWare Inc February 2014 - Present
Janssen Diagnostics, LLC April 2012 - February 2014
Ethicon Endo-Surgery November 2008 - April 2012
Publicis Managed Markets September 2006 - October 2008
NPS 2006 - 2006
Merck & Co., Inc. 1983 - 2006
Skills
Medicaid, Managed Care, Hospitals, Healthcare, Medical Devices, Medical Diagnostics, Medicare, Advocate Development, Oncology, Health Care Systems, Health Economics, Employer Groups, Cross-functional Team..., Pharmaceutical Sales, Product Launch, Cardiology, Pharmaceutical Industry, Health Policy, Healthcare Industry, Sales Effectiveness, Market Development, Urology, Diabetes, Neurology, Endocrinology, Gastroenterology, Market Access, Infectious Diseases, Management
Education
IMS
University of Illinois Springfield
MA
University of Wisconsin-Milwaukee
BA
Marilen N Costarelli's HeartWare Inc Experience April 2014 - Present
Job Owner at MNAC LLC
Industry Medical Devices
Experience
MNAC LLC July 2015 - Present
HeartWare Inc April 2014 - Present
UTC Aerospace Systems September 2012 - April 2014
King Engineering Associates September 2011 - February 2012
FIU Solar Decathlon 2011 January 2010 - December 2011
International Rescue Ministry July 2006 - December 2010
Skills
Environmental Compliance, Environmental..., Engineering, EHS, AutoCAD, Industrial Hygiene, Inspection, ISO 14001, Continuous Improvement, Process Improvement, Lean Manufacturing, Ergonomics, Water Quality, Remediation, OSHA, Engineering Management, Environmental Awareness, Environmental Impact..., ACE, TapRoot, Permit Preparation, Inventory Control, FMP, Lean Six Sigma, Root Cause Analysis, Environmental..., Leadership, Risk Assessment, Project Management, Training, SMS, CI, Policy Development
Education
Florida International University - College of Engineering & Computing 2005 — 2011
Bachelor of Science (B.S.), Environmental Engineering
Florida International University - College of Engineering & Computing 2005 — 2011
French Minor
Florida International University - College of Engineering & Computing 2005 — 2011
Chemistry Minor
MNAC LLC July 2015 - Present
HeartWare Inc April 2014 - Present
UTC Aerospace Systems September 2012 - April 2014
King Engineering Associates September 2011 - February 2012
FIU Solar Decathlon 2011 January 2010 - December 2011
International Rescue Ministry July 2006 - December 2010
Skills
Environmental Compliance, Environmental..., Engineering, EHS, AutoCAD, Industrial Hygiene, Inspection, ISO 14001, Continuous Improvement, Process Improvement, Lean Manufacturing, Ergonomics, Water Quality, Remediation, OSHA, Engineering Management, Environmental Awareness, Environmental Impact..., ACE, TapRoot, Permit Preparation, Inventory Control, FMP, Lean Six Sigma, Root Cause Analysis, Environmental..., Leadership, Risk Assessment, Project Management, Training, SMS, CI, Policy Development
Education
Florida International University - College of Engineering & Computing 2005 — 2011
Bachelor of Science (B.S.), Environmental Engineering
Florida International University - College of Engineering & Computing 2005 — 2011
French Minor
Florida International University - College of Engineering & Computing 2005 — 2011
Chemistry Minor
Jose Almodovar Jose Almodovar's HeartWare Inc Experience May 2015 - Present
Job Senior Director of Quality
Industry Medical Devices
Experience
HeartWare Inc May 2015 - Present
Baxter International Inc. April 2013 - May 2015
Baxter Healthcare July 2007 - April 2013
Boston Scientific January 2006 - July 2007
Skills
Strategic Planning, Quality System, ISO 13485, Manufacturing, Design Control, Technology Transfer, Medical Devices, FDA, Six Sigma, Engineering, Continuous Improvement, ISO 14971, Sop, Lean Manufacturing, Quality Management, CAPA, Quality Assurance, V&V, GMP, Process Improvement, ISO, Quality Control, Sterilization, Computer System..., Change Control, Operational Excellence, Injection Molding, Aseptic Processing, Automation, Leadership, Quality Auditing, Validation, 21 CFR Part 11, SPC, R&D, Root Cause Analysis, FDA GMP, Trackwise, DMAIC, GLP, cGMP practices, LIMS, Supplier Quality, Contract Manufacturing, GxP, Cleaning Validation, CQA, 21 CFR, Biopharmaceuticals, Regulatory Affairs
Education
Universidad de Puerto Rico 1982 — 1987
BSIE, Industrial Engineering
HeartWare Inc May 2015 - Present
Baxter International Inc. April 2013 - May 2015
Baxter Healthcare July 2007 - April 2013
Boston Scientific January 2006 - July 2007
Skills
Strategic Planning, Quality System, ISO 13485, Manufacturing, Design Control, Technology Transfer, Medical Devices, FDA, Six Sigma, Engineering, Continuous Improvement, ISO 14971, Sop, Lean Manufacturing, Quality Management, CAPA, Quality Assurance, V&V, GMP, Process Improvement, ISO, Quality Control, Sterilization, Computer System..., Change Control, Operational Excellence, Injection Molding, Aseptic Processing, Automation, Leadership, Quality Auditing, Validation, 21 CFR Part 11, SPC, R&D, Root Cause Analysis, FDA GMP, Trackwise, DMAIC, GLP, cGMP practices, LIMS, Supplier Quality, Contract Manufacturing, GxP, Cleaning Validation, CQA, 21 CFR, Biopharmaceuticals, Regulatory Affairs
Education
Universidad de Puerto Rico 1982 — 1987
BSIE, Industrial Engineering
Shawn Welsh's HeartWare Inc Experience May 2012 - May 2015
Job Coop Mechanical Engineer at Heartware Inc
Industry Medical Devices
Experience
HeartWare Inc May 2012 - May 2015
Skills
Microsoft Office, Problem Solving, Matlab, SolidWorks, Labview, Python, Medical Devices, Engineering, Design Control, CAD, Testing, PIV, Test Development, Design Verification, Design Validation, Biomedical Engineering, Fluid Dynamics, Mechanical Engineering, Customer Service
Education
Purdue University 2011 — 2016
BS, Mechanical Engineering
HeartWare Inc May 2012 - May 2015
Skills
Microsoft Office, Problem Solving, Matlab, SolidWorks, Labview, Python, Medical Devices, Engineering, Design Control, CAD, Testing, PIV, Test Development, Design Verification, Design Validation, Biomedical Engineering, Fluid Dynamics, Mechanical Engineering, Customer Service
Education
Purdue University 2011 — 2016
BS, Mechanical Engineering
Jack Roseberry Jack Roseberry's HeartWare Inc Experience April 2015 - Present
Job at
Industry Medical Devices
Experience
HeartWare Inc April 2015 - Present
St. Jude Medical June 2013 - April 2015
BIOTRONIK April 2011 - June 2013
Boston Scientific May 2009 - April 2011
Pfizer 1999 - 2009
Women's Health Sales - Pfizer 1999 - 2004
Skills
Medical Devices, Healthcare, Urology, Capital Equipment, Pacemakers, Clinical Research, Cardiac Rhythm..., Cardiology, Cath Lab, Electrophysiology, Hospitals, Interventional..., Medical Sales, Biotechnology, Contract Negotiation, Disposables, Managed Care, Market Development, Neurology, Operating Room, Pharmaceutical Industry, Pharmaceutical Sales, Product Launch, Sales, Sales Effectiveness, Sales Operations, Surgeons, Surgery, Surgical Instruments, Training, Vascular
Education
Syracuse University 1986 — 1990
Bachelors, Marketing/Advertising
HeartWare Inc April 2015 - Present
St. Jude Medical June 2013 - April 2015
BIOTRONIK April 2011 - June 2013
Boston Scientific May 2009 - April 2011
Pfizer 1999 - 2009
Women's Health Sales - Pfizer 1999 - 2004
Skills
Medical Devices, Healthcare, Urology, Capital Equipment, Pacemakers, Clinical Research, Cardiac Rhythm..., Cardiology, Cath Lab, Electrophysiology, Hospitals, Interventional..., Medical Sales, Biotechnology, Contract Negotiation, Disposables, Managed Care, Market Development, Neurology, Operating Room, Pharmaceutical Industry, Pharmaceutical Sales, Product Launch, Sales, Sales Effectiveness, Sales Operations, Surgeons, Surgery, Surgical Instruments, Training, Vascular
Education
Syracuse University 1986 — 1990
Bachelors, Marketing/Advertising
Edgar Colon, CPIM Edgar Colon, CPIM's HeartWare Inc Experience March 2010 - June 2011
Job Collections Logistics Manager at Medtronic
Industry Medical Devices
Experience
Conmed Linvatec July 2011 - December 2013
HeartWare Inc March 2010 - June 2011
2003 - Boston Scientific September 2003 - March 2010
Cordis Corp. January 2001 - September 2003
Microsoft January 1999 - January 2000
Davis & Geck 1995 - 1999
Baxter Pharmaseal 1987 - 1990
Skills
Materials Management, Purchasing, Inventory Management, Visio, Supply Chain, Lean Manufacturing, Inventory Control, Warehousing, 5S, Project Management, Business Strategy, Manufacturing, Logistics, Six Sigma, Value Stream Mapping, Supply Chain Management, Project Planning, Materials, Supplier Development, Quality Assurance, Kaizen, Strategy, Continuous Improvement, Forecasting, Strategic Sourcing, Kanban, Cross-functional Team..., MS Project, MRP, Process Scheduler, Process Improvement, Supply Management, Validation, SAP, Quality Management, DMAIC, Procurement, Production Planning, Supplier Quality, Negotiation, Global Sourcing, Product Development, Process Engineering, Root Cause Analysis, Manufacturing Operations, ISO, Sourcing, SPC, Quality System, ISO 13485
Education
Universidad de Puerto Rico 1980 — 1986
Bachelor Degree, Industrial Engineering
University of Puerto Rico 1980 — 1986
BSIE
Colegio Marista 1975 — 1978
Conmed Linvatec July 2011 - December 2013
HeartWare Inc March 2010 - June 2011
2003 - Boston Scientific September 2003 - March 2010
Cordis Corp. January 2001 - September 2003
Microsoft January 1999 - January 2000
Davis & Geck 1995 - 1999
Baxter Pharmaseal 1987 - 1990
Skills
Materials Management, Purchasing, Inventory Management, Visio, Supply Chain, Lean Manufacturing, Inventory Control, Warehousing, 5S, Project Management, Business Strategy, Manufacturing, Logistics, Six Sigma, Value Stream Mapping, Supply Chain Management, Project Planning, Materials, Supplier Development, Quality Assurance, Kaizen, Strategy, Continuous Improvement, Forecasting, Strategic Sourcing, Kanban, Cross-functional Team..., MS Project, MRP, Process Scheduler, Process Improvement, Supply Management, Validation, SAP, Quality Management, DMAIC, Procurement, Production Planning, Supplier Quality, Negotiation, Global Sourcing, Product Development, Process Engineering, Root Cause Analysis, Manufacturing Operations, ISO, Sourcing, SPC, Quality System, ISO 13485
Education
Universidad de Puerto Rico 1980 — 1986
Bachelor Degree, Industrial Engineering
University of Puerto Rico 1980 — 1986
BSIE
Colegio Marista 1975 — 1978
Stephen Depot Stephen Depot's HeartWare Inc Experience January 2015 - May 2015
Job Student at Rochester Institute of Technology
Industry Medical Devices
Experience
HeartWare Inc January 2015 - May 2015
GE Power & Water January 2014 - May 2014
Skills
Microsoft Word, PowerPoint, Teamwork, Social Media, Microsoft Excel, Microsoft Office, Data Analysis, Windows, Time Management, English, Analysis, Leadership, Outlook, Team Leadership, Project Planning, Solidworks, AutoCAD
Education
Rochester Institute of Technology 2012 — 2016
HeartWare Inc January 2015 - May 2015
GE Power & Water January 2014 - May 2014
Skills
Microsoft Word, PowerPoint, Teamwork, Social Media, Microsoft Excel, Microsoft Office, Data Analysis, Windows, Time Management, English, Analysis, Leadership, Outlook, Team Leadership, Project Planning, Solidworks, AutoCAD
Education
Rochester Institute of Technology 2012 — 2016
Brett Duebner, RN, BSN's HeartWare Inc Experience June 2015 - Present
Job Clinical Specialist with HeartWare, Inc.
Industry Hospital & Health Care
Experience
HeartWare Inc June 2015 - Present
Loyola University Medical Center September 2011 - May 2015
Loyola University Medical Center September 2008 - September 2011
Swig January 2005 - May 2008
Skills
Nursing Care, Critical Care Nursing, VAD, Heart Failure, Patient Education, Patient Advocacy, Microsoft Excel, Microsoft Word, PowerPoint, Public Speaking, IABP, ACLS, BLS, Nursing Education, Inpatient, Critical Care, ICU, Medical/Surgical, Telemetry, Healthcare, Healthcare Management, Hospitals, Medical-Surgical, Nursing, Epic Systems, Registered Nurses, Acute Care, Medical Devices, Cardiology, CPR Certified, Patient Safety
Education
Milwaukee School of Engineering 2005 — 2008
Bachelor of Science (BS), Registered Nursing/Registered Nurse
University of Wisconsin-Milwaukee 2004 — 2005
Bachelor's degree, Registered Nursing/Registered Nurse
University of Wisconsin-Madison 1999 — 2003
Bachelor of Science, Neurobiology and Neurosciences
HeartWare Inc June 2015 - Present
Loyola University Medical Center September 2011 - May 2015
Loyola University Medical Center September 2008 - September 2011
Swig January 2005 - May 2008
Skills
Nursing Care, Critical Care Nursing, VAD, Heart Failure, Patient Education, Patient Advocacy, Microsoft Excel, Microsoft Word, PowerPoint, Public Speaking, IABP, ACLS, BLS, Nursing Education, Inpatient, Critical Care, ICU, Medical/Surgical, Telemetry, Healthcare, Healthcare Management, Hospitals, Medical-Surgical, Nursing, Epic Systems, Registered Nurses, Acute Care, Medical Devices, Cardiology, CPR Certified, Patient Safety
Education
Milwaukee School of Engineering 2005 — 2008
Bachelor of Science (BS), Registered Nursing/Registered Nurse
University of Wisconsin-Milwaukee 2004 — 2005
Bachelor's degree, Registered Nursing/Registered Nurse
University of Wisconsin-Madison 1999 — 2003
Bachelor of Science, Neurobiology and Neurosciences
Chris Houdek, PMP Chris Houdek, PMP's HeartWare Inc Experience March 2015 - July 2015
Job Process Development Manager at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical July 2015 - Present
HeartWare Inc March 2015 - July 2015
Boston Scientific CRM 2006 - 2014
Boston Scientific CRM 2002 - 2006
Guidant 2000 - 2006
Skills
Medical Devices, Embedded Software, Software Engineering, Validation, Design Control, FDA, ISO 13485, R&D, V&V, Embedded Systems, Cross-functional Team..., ISO 14971, Manufacturing, Quality System, Design of Experiments, Project Management, Biomedical Engineering, FMEA, Testing, Product Development, Engineering Management, GMP, Product Launch, Continuous Improvement, Design for Manufacturing, CAPA, Quality Assurance, Manufacturing...
Education
Iowa State University
Bachelor's Degree, Electrical Engineering
St. Jude Medical July 2015 - Present
HeartWare Inc March 2015 - July 2015
Boston Scientific CRM 2006 - 2014
Boston Scientific CRM 2002 - 2006
Guidant 2000 - 2006
Skills
Medical Devices, Embedded Software, Software Engineering, Validation, Design Control, FDA, ISO 13485, R&D, V&V, Embedded Systems, Cross-functional Team..., ISO 14971, Manufacturing, Quality System, Design of Experiments, Project Management, Biomedical Engineering, FMEA, Testing, Product Development, Engineering Management, GMP, Product Launch, Continuous Improvement, Design for Manufacturing, CAPA, Quality Assurance, Manufacturing...
Education
Iowa State University
Bachelor's Degree, Electrical Engineering
Michael Jakubowski Michael Jakubowski's HeartWare Inc Experience January 2012 - September 2012
Job Senior Quality Engineer at Covidien
Industry Medical Devices
Experience
Covidien December 2012 - Present
Kelly Services January 2012 - September 2012
HeartWare Inc January 2012 - September 2012
Boston Scientific June 2011 - October 2011
Boston Scientific February 2011 - June 2011
Boston Scientific December 2008 - February 2011
Goode Consulting International June 2007 - November 2008
Skills
Medical Devices, Quality System, CAPA, Quality Assurance, Design Control, FMEA, Quality Control, Cross-functional Team..., Manufacturing, Engineering, Validation, Six Sigma, Product Development, Calibration, V&V
Education
University of Miami 2004 — 2008
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Covidien December 2012 - Present
Kelly Services January 2012 - September 2012
HeartWare Inc January 2012 - September 2012
Boston Scientific June 2011 - October 2011
Boston Scientific February 2011 - June 2011
Boston Scientific December 2008 - February 2011
Goode Consulting International June 2007 - November 2008
Skills
Medical Devices, Quality System, CAPA, Quality Assurance, Design Control, FMEA, Quality Control, Cross-functional Team..., Manufacturing, Engineering, Validation, Six Sigma, Product Development, Calibration, V&V
Education
University of Miami 2004 — 2008
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Sarah Mathew Sarah Mathew's HeartWare Inc Experience January 2015 - Present
Job Electrical Engineer at Heartware Inc.
Industry Medical Devices
Experience
HeartWare Inc January 2015 - Present
Thoratec Corporation October 2013 - December 2014
Boston Scientific September 2012 - May 2013
Thoratec June 2012 - August 2012
Harvard Medical School - Wyss Institute of Biologically Inspired Engineering June 2010 - August 2010
MIT- Francis Bitter Magnetics Lab June 2008 - August 2008
TiE - Boston June 2005 - June 2006
Skills
Solidworks, Agile Project Management, Matlab, COMSOL, LaserGene, LaTeX, Rapid Prototyping / 3D..., Genetic Engineering, Microfluidics, Material Science..., Adobe Premiere, Bloomberg Terminal, Biomaterials, Biomechanics, Design Control, Research, Biomedical Engineering, Labview, Materials Science, SolidWorks
Education
Franklin W. Olin College of Engineering 2009 — 2013
Bachelor of Engineering (BE)
National University of Singapore / NUS 2012 — 2012
The International School Bangalore 2006 — 2009
International Baccalaureate
HeartWare Inc January 2015 - Present
Thoratec Corporation October 2013 - December 2014
Boston Scientific September 2012 - May 2013
Thoratec June 2012 - August 2012
Harvard Medical School - Wyss Institute of Biologically Inspired Engineering June 2010 - August 2010
MIT- Francis Bitter Magnetics Lab June 2008 - August 2008
TiE - Boston June 2005 - June 2006
Skills
Solidworks, Agile Project Management, Matlab, COMSOL, LaserGene, LaTeX, Rapid Prototyping / 3D..., Genetic Engineering, Microfluidics, Material Science..., Adobe Premiere, Bloomberg Terminal, Biomaterials, Biomechanics, Design Control, Research, Biomedical Engineering, Labview, Materials Science, SolidWorks
Education
Franklin W. Olin College of Engineering 2009 — 2013
Bachelor of Engineering (BE)
National University of Singapore / NUS 2012 — 2012
The International School Bangalore 2006 — 2009
International Baccalaureate
Celestino De Hoyos Celestino De Hoyos's HeartWare Inc Experience March 2015 - Present
Job CSV Engineer
Industry Medical Devices
Experience
HeartWare Inc March 2015 - Present
MENTOR Technical Group Corporation March 2012 - March 2015
QRC Group, Inc. 2008 - 2012
GSK 2007 - 2008
PACIV 2004 - 2007
Skills
Validation, 21 CFR Part 11, FDA, GMP, Computer System..., GAMP, Automation, Pharmaceutical Industry, CAPA, Change Control, Manufacturing, Cleaning Validation, GxP, Quality System, SDLC, V&V, SOP, Medical Devices, Quality Assurance, Process Improvement, V, Root Cause Analysis, Quality Control, Project Management, PLC Programming, PLC Allen Bradley, FactoryTalk, HMIs, SCADA, Tablet Compression, Process Control, Water Systems Validation
Education
Universidad Politécnica de Puerto Rico 2002 — 2004
Master of Engineering (MEng), Manufacturing Engineering
Inter American University of Puerto Rico-Bayamon 1997 — 2002
Bachelor of Science (BS), Electrical and Electronics Engineering
HeartWare Inc March 2015 - Present
MENTOR Technical Group Corporation March 2012 - March 2015
QRC Group, Inc. 2008 - 2012
GSK 2007 - 2008
PACIV 2004 - 2007
Skills
Validation, 21 CFR Part 11, FDA, GMP, Computer System..., GAMP, Automation, Pharmaceutical Industry, CAPA, Change Control, Manufacturing, Cleaning Validation, GxP, Quality System, SDLC, V&V, SOP, Medical Devices, Quality Assurance, Process Improvement, V, Root Cause Analysis, Quality Control, Project Management, PLC Programming, PLC Allen Bradley, FactoryTalk, HMIs, SCADA, Tablet Compression, Process Control, Water Systems Validation
Education
Universidad Politécnica de Puerto Rico 2002 — 2004
Master of Engineering (MEng), Manufacturing Engineering
Inter American University of Puerto Rico-Bayamon 1997 — 2002
Bachelor of Science (BS), Electrical and Electronics Engineering
Michael C. Brown's HeartWare Inc Experience January 2010 - Present
Job Clinical Engineer
Industry Medical Devices
Experience
HeartWare Inc January 2010 - Present
Skills
Design Control, Medical Devices, CAPA, Design of Experiments, ISO 13485, V&V, Biomedical Engineering, Validation, FDA, Quality System, Cardiology, R&D, Biotechnology, Minitab, ISO 14971
Education
Penn State University 2005 — 2009
BS, Bioengineering
HeartWare Inc January 2010 - Present
Skills
Design Control, Medical Devices, CAPA, Design of Experiments, ISO 13485, V&V, Biomedical Engineering, Validation, FDA, Quality System, Cardiology, R&D, Biotechnology, Minitab, ISO 14971
Education
Penn State University 2005 — 2009
BS, Bioengineering
Lisa Nguyen Lisa Nguyen's HeartWare Inc Experience June 2013 - Present
Job
Industry Medical Devices
Experience
HeartWare Inc June 2013 - Present
Intuitive Surgical June 2010 - May 2013
Edwards Lifesciences August 2007 - June 2010
Guidant / Boston Scientific January 2006 - July 2007
IBM June 2001 - December 2005
IBM 2000 - 2000
IBM Global Services 1999 - 1999
IBM Microelectronics 1998 - 1998
Education
The Ohio State University 1997 — 2001
BS
HeartWare Inc June 2013 - Present
Intuitive Surgical June 2010 - May 2013
Edwards Lifesciences August 2007 - June 2010
Guidant / Boston Scientific January 2006 - July 2007
IBM June 2001 - December 2005
IBM 2000 - 2000
IBM Global Services 1999 - 1999
IBM Microelectronics 1998 - 1998
Education
The Ohio State University 1997 — 2001
BS
Carlos Munio's HeartWare Inc Experience September 2011 - 2012
Job Director of Supply Chain at Supply Chain Technologies
Industry Logistics and Supply Chain
Experience
HeartWare Inc. September 2011 - 2012
Amatheon Pharmaceuticals Inc. 2010 - 2011
All American Containers 2010 - 2011
Supply Chain Technologies Inc. January 2006 - November 2009
Abrika Pharmaceuticals 2005 - 2006
Teva (IVAX Pharmaceuticals) 2003 - 2005
Medtronic AVE 2000 - 2003
Johnson & Johnson (Cordis Corporation) 1997 - 2000
Baxter (Dade International) 1989 - 1997
Skills
APICS, Business Process Mapping, Process Improvement, Lean Manufacturing, Supply Chain Management, Supply Chain, Strategic Sourcing
Education
Nova Southeastern University
BS, Business Management
St. Brendan High School
HeartWare Inc. September 2011 - 2012
Amatheon Pharmaceuticals Inc. 2010 - 2011
All American Containers 2010 - 2011
Supply Chain Technologies Inc. January 2006 - November 2009
Abrika Pharmaceuticals 2005 - 2006
Teva (IVAX Pharmaceuticals) 2003 - 2005
Medtronic AVE 2000 - 2003
Johnson & Johnson (Cordis Corporation) 1997 - 2000
Baxter (Dade International) 1989 - 1997
Skills
APICS, Business Process Mapping, Process Improvement, Lean Manufacturing, Supply Chain Management, Supply Chain, Strategic Sourcing
Education
Nova Southeastern University
BS, Business Management
St. Brendan High School
Ramon Augusto Paz Ramon Augusto Paz's HeartWare Inc Experience October 2004 - August 2014
Job Medical Device Quality Professional
Industry Medical Devices
Experience
PAZQUAS LLC Quality Management System January 2015 - Present
HeartWare Inc October 2004 - August 2014
Scion Cardio-Vascular Inc October 2001 - September 2004
Medtronic Vascular July 1998 - September 2001
Cordis Corp 1983 - 1998
Skills
ISO 13485, Design Control, CAPA, FDA, V, ISO 14971, Quality System, CE marking, 21 CFR, Catheters, Medical Devices, Design for Manufacturing, Process Capability, Manufacturing, Product Launch, Quality Management
Education
New York Institute of Technology 1975 — 1979
BS, Engineering
PAZQUAS LLC Quality Management System January 2015 - Present
HeartWare Inc October 2004 - August 2014
Scion Cardio-Vascular Inc October 2001 - September 2004
Medtronic Vascular July 1998 - September 2001
Cordis Corp 1983 - 1998
Skills
ISO 13485, Design Control, CAPA, FDA, V, ISO 14971, Quality System, CE marking, 21 CFR, Catheters, Medical Devices, Design for Manufacturing, Process Capability, Manufacturing, Product Launch, Quality Management
Education
New York Institute of Technology 1975 — 1979
BS, Engineering
Christopher Zannini, BSIE, MBA, Six Sigma Black Belt Christopher Zannini, BSIE, MBA, Six Sigma Black Belt's HeartWare Inc Experience August 2011 - October 2012
Job Manufacturing Engineer
Industry Mechanical or Industrial Engineering
Experience
ACR ELECTRONICS October 2012 - July 2013
HeartWare Inc August 2011 - October 2012
Lexington International October 2010 - June 2011
Concept 2 Market January 2008 - October 2010
ATI, Inc March 2006 - January 2008
Boston Scientific May 2002 - January 2006
Skills
Continuous Improvement, Kaizen, Medical Devices, Lean Manufacturing, Six Sigma, Process Improvement, ISO, Cross-functional Team..., Operational Excellence, Logistics, Quality Assurance, Minitab, Electronics, FDA, Supply Chain Management, Root Cause Analysis, Quality Management, SPC, DMAIC, FMEA, Engineering, Process Engineering, Design of Experiments, CAPA, ISO 13485, Manufacturing, Quality System, Manufacturing..., Value Stream Mapping, 5S, Validation, Kanban, Manufacturing..., Manufacturing Operations, Industrial Engineering, Supply Chain, MRP, JIT, TQM, Quality Control, Supplier Quality, Iso 9000, Quality Auditing, R&D, Product Development, Black Belt, Engineering Management, Toyota Production System
Education
Nova Southeastern University 1997 — 1999
Masters, Business Administration
University of Miami 1989 — 1993
Bachelor of Science, Industrial Engineering
ACR ELECTRONICS October 2012 - July 2013
HeartWare Inc August 2011 - October 2012
Lexington International October 2010 - June 2011
Concept 2 Market January 2008 - October 2010
ATI, Inc March 2006 - January 2008
Boston Scientific May 2002 - January 2006
Skills
Continuous Improvement, Kaizen, Medical Devices, Lean Manufacturing, Six Sigma, Process Improvement, ISO, Cross-functional Team..., Operational Excellence, Logistics, Quality Assurance, Minitab, Electronics, FDA, Supply Chain Management, Root Cause Analysis, Quality Management, SPC, DMAIC, FMEA, Engineering, Process Engineering, Design of Experiments, CAPA, ISO 13485, Manufacturing, Quality System, Manufacturing..., Value Stream Mapping, 5S, Validation, Kanban, Manufacturing..., Manufacturing Operations, Industrial Engineering, Supply Chain, MRP, JIT, TQM, Quality Control, Supplier Quality, Iso 9000, Quality Auditing, R&D, Product Development, Black Belt, Engineering Management, Toyota Production System
Education
Nova Southeastern University 1997 — 1999
Masters, Business Administration
University of Miami 1989 — 1993
Bachelor of Science, Industrial Engineering
Alexa Jansey's HeartWare Inc Experience June 2015 - Present
Job Senior Computer Systems Validation QA Engineer
Industry Medical Devices
Experience
HeartWare Inc June 2015 - Present
HeartWare, Inc. March 2014 - June 2015
HeartWare, Inc. February 2013 - March 2014
HeartWare, Inc. June 2011 - February 2013
University of Denver October 2006 - June 2011
Boston Scientific June 2010 - September 2010
Boston Scientific June 2009 - September 2009
Boston Scientific June 2008 - September 2008
GE Industrial Plastics June 2007 - September 2007
Skills
Medical Devices, Six Sigma, Validation, FMEA, Engineering, Minitab, Labview, Lean Manufacturing, Cross-functional Team..., CAPA, Quality System, Quality Assurance, Process Improvement, Matlab, Database-driven Web..., Product Launch, Business Process..., Microsoft Office, Management, 5S, Manufacturing, Leadership, Technical Writing, ISO 13485, FDA, DMAIC, Analysis, Design Control
Education
University of Denver - Daniels College of Business 2010 — 2011
Masters, Business Administration
University of Denver School of Engineering 2006 — 2010
BSME, Mechanical Engineering, Mathematics, Medical Physics
Culver Academies 2002 — 2006
HeartWare Inc June 2015 - Present
HeartWare, Inc. March 2014 - June 2015
HeartWare, Inc. February 2013 - March 2014
HeartWare, Inc. June 2011 - February 2013
University of Denver October 2006 - June 2011
Boston Scientific June 2010 - September 2010
Boston Scientific June 2009 - September 2009
Boston Scientific June 2008 - September 2008
GE Industrial Plastics June 2007 - September 2007
Skills
Medical Devices, Six Sigma, Validation, FMEA, Engineering, Minitab, Labview, Lean Manufacturing, Cross-functional Team..., CAPA, Quality System, Quality Assurance, Process Improvement, Matlab, Database-driven Web..., Product Launch, Business Process..., Microsoft Office, Management, 5S, Manufacturing, Leadership, Technical Writing, ISO 13485, FDA, DMAIC, Analysis, Design Control
Education
University of Denver - Daniels College of Business 2010 — 2011
Masters, Business Administration
University of Denver School of Engineering 2006 — 2010
BSME, Mechanical Engineering, Mathematics, Medical Physics
Culver Academies 2002 — 2006
Jeffrey Blizard's HeartWare Inc Experience January 2011 - Present
Job
Industry Medical Devices
Experience
HeartWare Inc January 2011 - Present
Skills
Business Development, Capital Equipment, Cardiology, Cross-functional Team..., Disposables, Hospitals, Market Development, Marketing, Medical Devices, Operating Room, Product Launch, Sales, Sales Operations, Surgeons, Surgical Instruments, Urology, Vascular, Cardiac Surgery
Education
Saint Michael's College 1986 — 1990
Bachelor of Arts (B.A.)
HeartWare Inc January 2011 - Present
Skills
Business Development, Capital Equipment, Cardiology, Cross-functional Team..., Disposables, Hospitals, Market Development, Marketing, Medical Devices, Operating Room, Product Launch, Sales, Sales Operations, Surgeons, Surgical Instruments, Urology, Vascular, Cardiac Surgery
Education
Saint Michael's College 1986 — 1990
Bachelor of Arts (B.A.)
Judy Luttazi Judy Luttazi's HeartWare Inc Experience October 2012 - Present
Job Office Manager
Industry Executive Office
Experience
HeartWare Inc October 2012 - Present
Clarin Corporation, LLC October 2004 - July 2011
Tupperware January 2003 - January 2005
Integrated Rehabilitation Services May 1996 - July 1998
Integrated Rehabilitation Services/Darien Physical Therapy Center September 1994 - May 1996
Darien Physical Therapy Center March 1991 - September 1994
Skills
Office Management, Space planning, Executive Office..., Public Relations, Customer Service, Multi Tasking, Move Management, Marketing, Leadership, Human Resources, Organizational..., Healthcare, Project Management, Employee Relations, Facilities Management, Sales, Cross-functional Team..., Management, Event Planning, Microsoft Office, Strategic Planning, Administration
Education
Springfield College
Bachelor of Science, Sports Biology
HeartWare Inc October 2012 - Present
Clarin Corporation, LLC October 2004 - July 2011
Tupperware January 2003 - January 2005
Integrated Rehabilitation Services May 1996 - July 1998
Integrated Rehabilitation Services/Darien Physical Therapy Center September 1994 - May 1996
Darien Physical Therapy Center March 1991 - September 1994
Skills
Office Management, Space planning, Executive Office..., Public Relations, Customer Service, Multi Tasking, Move Management, Marketing, Leadership, Human Resources, Organizational..., Healthcare, Project Management, Employee Relations, Facilities Management, Sales, Cross-functional Team..., Management, Event Planning, Microsoft Office, Strategic Planning, Administration
Education
Springfield College
Bachelor of Science, Sports Biology
Andy Senda Andy Senda's HeartWare Inc Experience April 2010 - Present
Job Principal Quality Assurance Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc April 2010 - Present
Cordis August 2009 - April 2010
BitHelix, LLC January 2009 - August 2009
Johnson & Johnson January 2006 - February 2009
Skills
Design Control, Process Simulation, Validation, Medical Devices, Management, Solidworks, Six Sigma, Biomedical Engineering, Testing, Quality System, Design of Experiments, R&D, ISO 13485, FDA, cGMP manufacturing, V&V
Education
University of Miami 2001 — 2005
B.S., Biomedical Engineering (Electrical)
HeartWare Inc April 2010 - Present
Cordis August 2009 - April 2010
BitHelix, LLC January 2009 - August 2009
Johnson & Johnson January 2006 - February 2009
Skills
Design Control, Process Simulation, Validation, Medical Devices, Management, Solidworks, Six Sigma, Biomedical Engineering, Testing, Quality System, Design of Experiments, R&D, ISO 13485, FDA, cGMP manufacturing, V&V
Education
University of Miami 2001 — 2005
B.S., Biomedical Engineering (Electrical)
Brad Aurilia Brad Aurilia's HeartWare Inc Experience January 2012 - Present
Job Principal Engineer II Medical Device Design
Industry Medical Devices
Experience
HeartWare Inc January 2012 - Present
Boston Scientific January 2010 - January 2012
W.L. Gore & Associates April 2005 - April 2009
Cordis January 2002 - April 2005
Boston Scientific March 1997 - January 2002
Skills
Medical Devices, Solidworks, Six Sigma, Catheters, R&D, Manufacturing, Design Control, FDA, ISO 13485, Continuous Improvement, Manufacturing..., Minitab, Design of Experiments, Root Cause Analysis, SPC, Product Development, CAPA, Quality System, Validation, Electronics, Testing, Engineering, Cross-functional Team..., CAD, V&V, Design for Manufacturing, FMEA
Education
New Jersey Institute of Technology 1992 — 1996
BSME, Mechanical Engineering
New Jersey Institute of Technology 1992 — 1996
BSME
HeartWare Inc January 2012 - Present
Boston Scientific January 2010 - January 2012
W.L. Gore & Associates April 2005 - April 2009
Cordis January 2002 - April 2005
Boston Scientific March 1997 - January 2002
Skills
Medical Devices, Solidworks, Six Sigma, Catheters, R&D, Manufacturing, Design Control, FDA, ISO 13485, Continuous Improvement, Manufacturing..., Minitab, Design of Experiments, Root Cause Analysis, SPC, Product Development, CAPA, Quality System, Validation, Electronics, Testing, Engineering, Cross-functional Team..., CAD, V&V, Design for Manufacturing, FMEA
Education
New Jersey Institute of Technology 1992 — 1996
BSME, Mechanical Engineering
New Jersey Institute of Technology 1992 — 1996
BSME
Diarmaid O'Donoghue's HeartWare Inc Experience December 2011 - November 2014
Job Controller at Apple Tree Partners
Industry Venture Capital & Private Equity
Experience
Apple Tree Partners December 2014 - Present
Community Economic Development Center of Southeastern MA 2009 - Present
Hersha Hospitality 2008 - Present
HeartWare Inc December 2011 - November 2014
UNICOM Technology Group 2005 - 2007
Jenzabar 2003 - 2005
Stream Global Services 2001 - 2003
Streamline.com, Inc 1999 - 2001
American Stores 1989 - 1999
Touche Ross (Deloitte Touche Tohmatsu Limited) 1988 - 1989
Skills
Financial Analysis, CRM, General Ledger, Cost Control, SEC filings, Revenue Recognition, Accounts Receivable, Corporate Finance, Cash Flow, Risk Management, Microsoft Excel, Management, Accounts Payable, Account Reconciliation, Finance, SEC Filings, Accounting
Education
University of Massachusetts Dartmouth 2010 — 2011
MBA, Business Administration
Suffolk University - Sawyer Business School 1999 — 1999
Graduate studies in Business Management
Westminster College 1996 — 1998
Graduate studies in Business Management
Saint Joseph's College 1984 — 1988
BSBA, Business Administration/Accounting
Apple Tree Partners December 2014 - Present
Community Economic Development Center of Southeastern MA 2009 - Present
Hersha Hospitality 2008 - Present
HeartWare Inc December 2011 - November 2014
UNICOM Technology Group 2005 - 2007
Jenzabar 2003 - 2005
Stream Global Services 2001 - 2003
Streamline.com, Inc 1999 - 2001
American Stores 1989 - 1999
Touche Ross (Deloitte Touche Tohmatsu Limited) 1988 - 1989
Skills
Financial Analysis, CRM, General Ledger, Cost Control, SEC filings, Revenue Recognition, Accounts Receivable, Corporate Finance, Cash Flow, Risk Management, Microsoft Excel, Management, Accounts Payable, Account Reconciliation, Finance, SEC Filings, Accounting
Education
University of Massachusetts Dartmouth 2010 — 2011
MBA, Business Administration
Suffolk University - Sawyer Business School 1999 — 1999
Graduate studies in Business Management
Westminster College 1996 — 1998
Graduate studies in Business Management
Saint Joseph's College 1984 — 1988
BSBA, Business Administration/Accounting
Matthew Wiggins, Ph.D. Matthew Wiggins, Ph.D.'s HeartWare Inc Experience September 2012 - October 2014
Job Senior Algorithm Manager, Simband at Samsung Strategy and Innovation Center
Industry Medical Devices
Experience
Samsung Strategy and Innovation Center October 2014 - Present
HeartWare Inc September 2012 - October 2014
TIAX LLC April 2007 - September 2012
Georgia Tech – Intelligent Control Systems Lab, Biomedical Group January 2003 - April 2007
Raptor International May 2006 - November 2006
Georgia Tech Microelectronics Lab May 2002 - December 2002
Medside Home Health Agency January 2002 - May 2002
Motorola Corporation May 2001 - August 2001
Motorola May 2000 - August 2000
Skills
Image Processing, Data Mining, DSP, Pattern Recognition, Matlab, Signal Processing, Machine Learning, C, Embedded Systems, Sensors, Microcontrollers, Program Management, Modeling, Systems Engineering, Algorithms, Simulink, Electronics, R, Biomedical Engineering, Engineering Management, Data Analysis, Firmware, Software Engineering, Embedded C, Programming, Proposal Writing, Medical Devices, Embedded Software, Digital Signal..., Computer Vision, R&D, Product Development, Simulations, Testing
Education
Georgia Institute of Technology 2003 — 2007
Ph.D., Bioengineering
Georgia Institute of Technology 2002 — 2006
MS, Electrical Engineering
Georgia Institute of Technology 1998 — 2002
BS, Electrical Engineering
Lassiter High School 1994 — 1998
Samsung Strategy and Innovation Center October 2014 - Present
HeartWare Inc September 2012 - October 2014
TIAX LLC April 2007 - September 2012
Georgia Tech – Intelligent Control Systems Lab, Biomedical Group January 2003 - April 2007
Raptor International May 2006 - November 2006
Georgia Tech Microelectronics Lab May 2002 - December 2002
Medside Home Health Agency January 2002 - May 2002
Motorola Corporation May 2001 - August 2001
Motorola May 2000 - August 2000
Skills
Image Processing, Data Mining, DSP, Pattern Recognition, Matlab, Signal Processing, Machine Learning, C, Embedded Systems, Sensors, Microcontrollers, Program Management, Modeling, Systems Engineering, Algorithms, Simulink, Electronics, R, Biomedical Engineering, Engineering Management, Data Analysis, Firmware, Software Engineering, Embedded C, Programming, Proposal Writing, Medical Devices, Embedded Software, Digital Signal..., Computer Vision, R&D, Product Development, Simulations, Testing
Education
Georgia Institute of Technology 2003 — 2007
Ph.D., Bioengineering
Georgia Institute of Technology 2002 — 2006
MS, Electrical Engineering
Georgia Institute of Technology 1998 — 2002
BS, Electrical Engineering
Lassiter High School 1994 — 1998
Frank Arredondo Frank Arredondo's HeartWare Inc Experience July 2014 - Present
Job IT Support Manager at HeartWare
Industry Medical Devices
Experience
HeartWare Inc July 2014 - Present
PerkinElmer June 2011 - June 2014
TekSystems 2014 - 2014
TekSystems 2014 - 2014
Interactive Data September 2005 - June 2011
Skills
Disaster Recovery, IT Management, Data Center, Microsoft SQL Server, VMware, Project Management, Microsoft Exchange, Market Data, Windows Server, Active Directory, Virtualization, Storage Area Networks, EMC Storage, Servers, Storage, Windows, Vendor Management, Cloud Computing, Networking
Education
Castle College
AS, Business Administration
Northeastern University
Information Systems
HeartWare Inc July 2014 - Present
PerkinElmer June 2011 - June 2014
TekSystems 2014 - 2014
TekSystems 2014 - 2014
Interactive Data September 2005 - June 2011
Skills
Disaster Recovery, IT Management, Data Center, Microsoft SQL Server, VMware, Project Management, Microsoft Exchange, Market Data, Windows Server, Active Directory, Virtualization, Storage Area Networks, EMC Storage, Servers, Storage, Windows, Vendor Management, Cloud Computing, Networking
Education
Castle College
AS, Business Administration
Northeastern University
Information Systems
Bonnie Au's HeartWare Inc Experience January 2013 - July 2014
Job Systems Engineer at Fresenius Kabi USA
Industry Research
Experience
Fresenius Kabi USA June 2015 - Present
Clinical Nutrition Research Center January 2013 - April 2015
Illinois Institute of Technology June 2011 - April 2015
HeartWare Inc January 2013 - July 2014
Illinois Institute of Technology August 2009 - May 2010
Research Experience: Undergraduates at Illinois Institute of Technology May 2009 - August 2009
Illinois Institute of Technology May 2008 - May 2009
Skills
Biomedical Engineering, Biomaterials, Experimentation, Matlab, Labview, Tissue Engineering, Cell Culture, Spectrophotometry, Fluorescence Microscopy, Confocal Microscopy, Cell, Microsoft Office, Microsoft Excel, Microsoft Word, ImageJ, LabVIEW
Education
Illinois Institute of Technology 2011 — 2015
Master of Science in Biomedical Engineering, Cell and Tissue Engineering
Illinois Institute of Technology 2007 — 2011
Biomedical Engineering, Cell and Tissue Engineering, 3.53/4.00
Fresenius Kabi USA June 2015 - Present
Clinical Nutrition Research Center January 2013 - April 2015
Illinois Institute of Technology June 2011 - April 2015
HeartWare Inc January 2013 - July 2014
Illinois Institute of Technology August 2009 - May 2010
Research Experience: Undergraduates at Illinois Institute of Technology May 2009 - August 2009
Illinois Institute of Technology May 2008 - May 2009
Skills
Biomedical Engineering, Biomaterials, Experimentation, Matlab, Labview, Tissue Engineering, Cell Culture, Spectrophotometry, Fluorescence Microscopy, Confocal Microscopy, Cell, Microsoft Office, Microsoft Excel, Microsoft Word, ImageJ, LabVIEW
Education
Illinois Institute of Technology 2011 — 2015
Master of Science in Biomedical Engineering, Cell and Tissue Engineering
Illinois Institute of Technology 2007 — 2011
Biomedical Engineering, Cell and Tissue Engineering, 3.53/4.00
Frank Richichi's HeartWare Inc Experience March 2014 - Present
Job Senior Software Engineer at Philips Lighting
Industry Medical Devices
Experience
Philips Lighting April 2015 - Present
HeartWare Inc March 2014 - Present
Skills
Java, C++, Linux, Python, Qt, GUI, X11, UML, C, OOAD, Object Oriented Design, Embedded Systems, Embedded Linux, RTOS, Subversion, SQL, Software Development, Unix, Architecture, Requirements Analysis, Software Design
Education
Tufts University 1974 — 1978
MS
New York University 1968 — 1972
BSEE
Stanford University
Graduate Courses
Philips Lighting April 2015 - Present
HeartWare Inc March 2014 - Present
Skills
Java, C++, Linux, Python, Qt, GUI, X11, UML, C, OOAD, Object Oriented Design, Embedded Systems, Embedded Linux, RTOS, Subversion, SQL, Software Development, Unix, Architecture, Requirements Analysis, Software Design
Education
Tufts University 1974 — 1978
MS
New York University 1968 — 1972
BSEE
Stanford University
Graduate Courses
Vince Cannon, RN, BSN, MBA's HeartWare Inc Experience July 2014 - Present
Job Clinical Affairs Manager
Industry Biotechnology
Experience
HeartWare Inc July 2014 - Present
HeartWare Inc August 2009 - Present
Abiomed, Inc. August 2006 - August 2009
Noteworthy Medical Systems June 2005 - August 2006
Skills
Medical Devices, Capital Equipment, Cath Lab, Clinical Research, Clinical Trials, Critical Care, Disposables, Healthcare, Hospitals, Interventional..., Interventional Radiology, Market Development, Operating Room, Product Launch, Surgeons, Surgery, Vascular, Cardiology, Healthcare Information..., Nursing, Biotechnology, Cardiac Surgery
Education
University of Phoenix 2004 — 2005
MBA, Business Administration
Kent State University 1992 — 1997
BSN, Nursing
HeartWare Inc July 2014 - Present
HeartWare Inc August 2009 - Present
Abiomed, Inc. August 2006 - August 2009
Noteworthy Medical Systems June 2005 - August 2006
Skills
Medical Devices, Capital Equipment, Cath Lab, Clinical Research, Clinical Trials, Critical Care, Disposables, Healthcare, Hospitals, Interventional..., Interventional Radiology, Market Development, Operating Room, Product Launch, Surgeons, Surgery, Vascular, Cardiology, Healthcare Information..., Nursing, Biotechnology, Cardiac Surgery
Education
University of Phoenix 2004 — 2005
MBA, Business Administration
Kent State University 1992 — 1997
BSN, Nursing
William Hidden's HeartWare Inc Experience August 2014 - Present
Job Principal Software Engineer, Tools & Test at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc August 2014 - Present
BioScale September 2007 - July 2014
Boston Scientific August 2006 - August 2007
Bose March 2004 - August 2006
Argose March 2001 - February 2003
Argose March 2001 - February 2003
Aurora Technologies September 1999 - March 2001
Bayer Diagnostics January 1989 - August 1999
Bayer Healthcare, Medfield, MA 1989 - 1999
Geophysical Institute January 1980 - July 1985
Skills
Embedded Systems, Object Oriented Design, Visual Studio, Software Development, Embedded Software, Firmware, Architecture, Architectures, Product Development, C#, Medical Devices, C, UML, Software Engineering, Linux, Perl, C++, Testing
Education
University of Massachusetts Boston 1987 — 1989
BS
University of Alaska Fairbanks 1979 — 1985
HeartWare Inc August 2014 - Present
BioScale September 2007 - July 2014
Boston Scientific August 2006 - August 2007
Bose March 2004 - August 2006
Argose March 2001 - February 2003
Argose March 2001 - February 2003
Aurora Technologies September 1999 - March 2001
Bayer Diagnostics January 1989 - August 1999
Bayer Healthcare, Medfield, MA 1989 - 1999
Geophysical Institute January 1980 - July 1985
Skills
Embedded Systems, Object Oriented Design, Visual Studio, Software Development, Embedded Software, Firmware, Architecture, Architectures, Product Development, C#, Medical Devices, C, UML, Software Engineering, Linux, Perl, C++, Testing
Education
University of Massachusetts Boston 1987 — 1989
BS
University of Alaska Fairbanks 1979 — 1985
Rama Upadhyaya's HeartWare Inc Experience 2012 - Present
Job
Industry Medical Devices
Experience
HeartWare Inc 2012 - Present
Boston Scientific April 2008 - January 2012
Diamond Innovations November 2004 - April 2008
Chand Kare Advanced Ceramics/ Prematech Advanced Ceramics 2003 - 2004
Kirloskar Toyoda 1998 - 2000
Skills
CAPA, Design Control, Medical Devices, V&V, ISO 13485, DMAIC, FMEA, ISO 14971, Manufacturing, FDA, Design of Experiments, Manufacturing..., Minitab, Quality System, Root Cause Analysis, Six Sigma, Validation, SPC, Design for Manufacturing, Lean Manufacturing, Biomedical Engineering, Process Capability, ISO, Gage R&R, CQE
Education
University of Florida - Warrington College Of Business 2009 — 2011
Master of Business Administration (MBA)
University of Massachusetts, Amherst 2000 — 2003
Master of Science (MS)
NIE, Mysore 1994 — 1998
Bachelor of Engineering (B.E.)
HeartWare Inc 2012 - Present
Boston Scientific April 2008 - January 2012
Diamond Innovations November 2004 - April 2008
Chand Kare Advanced Ceramics/ Prematech Advanced Ceramics 2003 - 2004
Kirloskar Toyoda 1998 - 2000
Skills
CAPA, Design Control, Medical Devices, V&V, ISO 13485, DMAIC, FMEA, ISO 14971, Manufacturing, FDA, Design of Experiments, Manufacturing..., Minitab, Quality System, Root Cause Analysis, Six Sigma, Validation, SPC, Design for Manufacturing, Lean Manufacturing, Biomedical Engineering, Process Capability, ISO, Gage R&R, CQE
Education
University of Florida - Warrington College Of Business 2009 — 2011
Master of Business Administration (MBA)
University of Massachusetts, Amherst 2000 — 2003
Master of Science (MS)
NIE, Mysore 1994 — 1998
Bachelor of Engineering (B.E.)
Elaine Chaison's HeartWare Inc Experience September 2012 - August 2013
Job Brand Specialist, Brand Marketing, Minimally Invasive Therapies Group at Medtronic
Industry Information Technology and Services
Experience
Medtronic December 2014 - May 2015
National Braille Press August 2014 - December 2014
HeartWare Inc September 2012 - August 2013
CA Technologies April 2010 - July 2011
IDC April 2007 - May 2008
Skills
Research, SharePoint, Program Management, Project Management, Visio, Management, Product Development, Notary Public, Microsoft Office, Nonprofits, Organization Skills, Human Resources, Community Outreach, Customer Service
Education
University of Massachusetts, Amherst
B.A., Sociology
Northeastern University
Business Management
Massachusetts Bay Community College
Associate of Arts (A.A.), Liberal Arts and Sciences/Liberal Studies
Medtronic December 2014 - May 2015
National Braille Press August 2014 - December 2014
HeartWare Inc September 2012 - August 2013
CA Technologies April 2010 - July 2011
IDC April 2007 - May 2008
Skills
Research, SharePoint, Program Management, Project Management, Visio, Management, Product Development, Notary Public, Microsoft Office, Nonprofits, Organization Skills, Human Resources, Community Outreach, Customer Service
Education
University of Massachusetts, Amherst
B.A., Sociology
Northeastern University
Business Management
Massachusetts Bay Community College
Associate of Arts (A.A.), Liberal Arts and Sciences/Liberal Studies
Jeff LaRose's HeartWare Inc Experience 1999 - 2008
Job Chief Scientific Officer at HeartWare
Industry Medical Devices
Experience
HeartWare CSOHeartWare2005 - 2009
HeartWare Inc 1999 - 2008
Skills
Biomedical Engineering, ISO 13485, Medical Devices, FDA, Design Control, R&D, Commercialization, Cardiology, Product Development, CAPA, Clinical Trials, Biotechnology, Quality System, Validation, Design of Experiments
Education
The University of Akron 1980 — 1986
MSME, Mechanical Engineering
HeartWare CSOHeartWare2005 - 2009
HeartWare Inc 1999 - 2008
Skills
Biomedical Engineering, ISO 13485, Medical Devices, FDA, Design Control, R&D, Commercialization, Cardiology, Product Development, CAPA, Clinical Trials, Biotechnology, Quality System, Validation, Design of Experiments
Education
The University of Akron 1980 — 1986
MSME, Mechanical Engineering
Jill Bridge's HeartWare Inc Experience March 2013 - Present
Job North America Southeastern Region Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2013 - Present
HeartWare Inc December 2010 - March 2013
Terumo Cardiovascular Systems July 2007 - December 2010
Ethicon Biosurgery July 1999 - June 2007
Skills
Medical Devices, Product Development, Cardiac Surgery
Education
Salem College 1995 — 1999
Bachelor of Arts (BA), Communication and Media Studies
HeartWare Inc March 2013 - Present
HeartWare Inc December 2010 - March 2013
Terumo Cardiovascular Systems July 2007 - December 2010
Ethicon Biosurgery July 1999 - June 2007
Skills
Medical Devices, Product Development, Cardiac Surgery
Education
Salem College 1995 — 1999
Bachelor of Arts (BA), Communication and Media Studies
Chris Pierson, PMP's HeartWare Inc Experience February 2012 - Present
Job Principal Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc February 2012 - Present
Boston Scientific April 2011 - January 2012
Boston Scientific February 2002 - April 2011
Buckbee Mears 1999 - 2001
Skills
Process Validation, FDA, Biomedical Engineering, CAPA, Design Control, Medical Devices, Measurement System..., Six Sigma, Manufacturing, Quality Systems, Minitab, DOE, Gage R&R, Process Capability, Pareto Analysis, Control Charts, SIPOC, Value Stream, PMP, PMI, V&V, Gantt, GMP, Lean Manufacturing, Design of Experiments, Root Cause Analysis, Quality System, Value Stream Mapping, Validation, Catheters, ISO, DMAIC, ISO 14971
Education
University of Florida - Warrington College of Business Administration 2008 — 2010
MBA
University of Minnesota-Twin Cities 1994 — 1999
B.S., Materials Science Engineering
Park Senior High School 1991 — 1994
HeartWare Inc February 2012 - Present
Boston Scientific April 2011 - January 2012
Boston Scientific February 2002 - April 2011
Buckbee Mears 1999 - 2001
Skills
Process Validation, FDA, Biomedical Engineering, CAPA, Design Control, Medical Devices, Measurement System..., Six Sigma, Manufacturing, Quality Systems, Minitab, DOE, Gage R&R, Process Capability, Pareto Analysis, Control Charts, SIPOC, Value Stream, PMP, PMI, V&V, Gantt, GMP, Lean Manufacturing, Design of Experiments, Root Cause Analysis, Quality System, Value Stream Mapping, Validation, Catheters, ISO, DMAIC, ISO 14971
Education
University of Florida - Warrington College of Business Administration 2008 — 2010
MBA
University of Minnesota-Twin Cities 1994 — 1999
B.S., Materials Science Engineering
Park Senior High School 1991 — 1994
David Hathaway, MD's HeartWare Inc Experience June 2008 - Present
Job Chief Medical Officer
Industry Pharmaceuticals
Experience
HeartWare Inc June 2008 - Present
Education
Indiana University School of Medicine 1970 — 1975
HeartWare Inc June 2008 - Present
Education
Indiana University School of Medicine 1970 — 1975
Hailee Lampert's HeartWare Inc Experience August 2013 - Present
Job Corporate Communications Manager at HeartWare Inc
Industry Public Relations and Communications
Experience
HeartWare Inc August 2013 - Present
Davies Murphy Group July 2012 - July 2013
Peritus September 2010 - July 2012
WLKY-TV September 2007 - September 2010
WPTZ-TV June 2005 - August 2007
Skills
Media Relations, Social Media Integration, Ap Style, Press Releases, News Writing, Strategic Communications, Strategic Planning, Public Relations, Broadcast Journalism, Corporate Communications, Internal & External..., Event Management, Content Development, Account Management, Advertising, Analyst Relations, Message Development, Event Planning, Web Content, Brand Management, Video Production
Education
Northwestern University 2004 — 2005
MSJ, Broadcast Journalism
Northwestern University 2000 — 2004
BSJ, Broadcast Journalism
HeartWare Inc August 2013 - Present
Davies Murphy Group July 2012 - July 2013
Peritus September 2010 - July 2012
WLKY-TV September 2007 - September 2010
WPTZ-TV June 2005 - August 2007
Skills
Media Relations, Social Media Integration, Ap Style, Press Releases, News Writing, Strategic Communications, Strategic Planning, Public Relations, Broadcast Journalism, Corporate Communications, Internal & External..., Event Management, Content Development, Account Management, Advertising, Analyst Relations, Message Development, Event Planning, Web Content, Brand Management, Video Production
Education
Northwestern University 2004 — 2005
MSJ, Broadcast Journalism
Northwestern University 2000 — 2004
BSJ, Broadcast Journalism
Steven Stanton's HeartWare Inc Experience May 2011 - Present
Job Engineering Manager Software at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc May 2011 - Present
Draeger Medical 2009 - May 2011
Draeger 2007 - 2009
Draeger 2006 - 2007
3Com 1998 - 2002
Skills
Embedded Systems, Software Project..., Medical Devices, Patient Monitoring, Team Leadership, Cross-functional..., Remote Access, Remote Team Management, Communication Protocols, Medical Monitoring, R&D, Software Engineering, Product Lifecycle..., ISO 13485, Quality Assurance, Testing, Embedded Software, Virtual Teams, Software Development, Design Control, Manufacturing, Cross-functional Team..., TestTrack, FDA, Product Development, Engineering Management, Management
Education
Gordon Conwell Theological Seminary 1983 — 1985
Master of Divinity
University of California, Berkeley 1976 — 1980
Bachelor of Science, Physics and (Pure) Mathematics
HeartWare Inc May 2011 - Present
Draeger Medical 2009 - May 2011
Draeger 2007 - 2009
Draeger 2006 - 2007
3Com 1998 - 2002
Skills
Embedded Systems, Software Project..., Medical Devices, Patient Monitoring, Team Leadership, Cross-functional..., Remote Access, Remote Team Management, Communication Protocols, Medical Monitoring, R&D, Software Engineering, Product Lifecycle..., ISO 13485, Quality Assurance, Testing, Embedded Software, Virtual Teams, Software Development, Design Control, Manufacturing, Cross-functional Team..., TestTrack, FDA, Product Development, Engineering Management, Management
Education
Gordon Conwell Theological Seminary 1983 — 1985
Master of Divinity
University of California, Berkeley 1976 — 1980
Bachelor of Science, Physics and (Pure) Mathematics
Jesica McLane's HeartWare Inc Experience March 2014 - August 2014
Job Regulatory Affairs Manager at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical September 2014 - Present
HeartWare Inc March 2014 - August 2014
HeartWare Inc May 2012 - March 2014
HeartWare Inc April 2009 - April 2012
Cordis July 2006 - December 2008
Skills
Design Control, ISO 13485, FDA, Medical Devices, ISO 14971, CAPA, V&V, Quality System, Biomedical Engineering, Validation, Design of Experiments, Catheters, GMP, Minitab, Product Development, R&D, Biomaterials, FDA GMP, FMEA, Gage R&R, DMAIC, Biotechnology, 21 CFR, Regulatory Affairs, Regulatory Submissions, Change Control, 21 CFR Part 11, Commercialization, Technology Transfer, PMA, CE marking, Medical Device Directive
Education
Georgia Institute of Technology 2004 — 2006
MS, Biomedical Engineering
University of Florida 1999 — 2004
Bachelor of Science (BS), Material Science and Engineering
Bolton Medical September 2014 - Present
HeartWare Inc March 2014 - August 2014
HeartWare Inc May 2012 - March 2014
HeartWare Inc April 2009 - April 2012
Cordis July 2006 - December 2008
Skills
Design Control, ISO 13485, FDA, Medical Devices, ISO 14971, CAPA, V&V, Quality System, Biomedical Engineering, Validation, Design of Experiments, Catheters, GMP, Minitab, Product Development, R&D, Biomaterials, FDA GMP, FMEA, Gage R&R, DMAIC, Biotechnology, 21 CFR, Regulatory Affairs, Regulatory Submissions, Change Control, 21 CFR Part 11, Commercialization, Technology Transfer, PMA, CE marking, Medical Device Directive
Education
Georgia Institute of Technology 2004 — 2006
MS, Biomedical Engineering
University of Florida 1999 — 2004
Bachelor of Science (BS), Material Science and Engineering
Jaime Franco's HeartWare Inc Experience 2012 - 2014
Job Sr Manufacturing Engineering Technician at HeartWare
Industry Medical Devices
Experience
HeartWare Inc 2012 - 2014
SafeStitch Medical January 2010 - August 2012
Cordis, Johnson & Johnson January 1992 - January 2010
Skills
FTIR, Design Control, ISO 13485, Medical Devices, V&V, FDA, CAPA, Validation, GMP, Design of Experiments, Minitab, Biomedical Engineering, Quality System, R&D, FMEA, Manufacturing, Commercialization, Product Launch, Failure Analysis, Product Development, Solidworks, Root Cause Analysis, Design for Manufacturing, ISO, DMAIC, ISO 14971, Process Simulation, Calibration, Quality Control, Lean Manufacturing, Change Control, SPC, Quality Assurance, 21 CFR Part 11, Manufacturing...
Education
Miami Dade College 1998 — 2002
AS, Electronic Engineering Technology
HeartWare Inc 2012 - 2014
SafeStitch Medical January 2010 - August 2012
Cordis, Johnson & Johnson January 1992 - January 2010
Skills
FTIR, Design Control, ISO 13485, Medical Devices, V&V, FDA, CAPA, Validation, GMP, Design of Experiments, Minitab, Biomedical Engineering, Quality System, R&D, FMEA, Manufacturing, Commercialization, Product Launch, Failure Analysis, Product Development, Solidworks, Root Cause Analysis, Design for Manufacturing, ISO, DMAIC, ISO 14971, Process Simulation, Calibration, Quality Control, Lean Manufacturing, Change Control, SPC, Quality Assurance, 21 CFR Part 11, Manufacturing...
Education
Miami Dade College 1998 — 2002
AS, Electronic Engineering Technology
William Trueba's HeartWare Inc Experience March 2010 - Present
Job Senior NPD Technician and Machinist at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2010 - Present
Skeletal Dynamics, LLC June 2009 - November 2009
Cordis a Johnson and Johnson Co. April 1996 - December 2007
Cordis, Johnson & Johnson 1998 - 2007
Cordis Endovacular, Johnson & Johnson 1996 - 2007
Cordis Corp. 1995 - 2007
Skills
Product Development, Medical Devices, Design Control, ISO 13485, CAPA, V&V, FDA, Biomedical Engineering, Validation, Design of Experiments, Quality System, Minitab, Manufacturing, ISO 14971, R&D, GMP, Lean Manufacturing, Quality Assurance
Education
Miami Dade College 1996 — 2000
Associate of Science (A.S.), Electronic Engineering Technology
Manuel Ascunze Pedagogical School Cuba 1988 — 1993
BS, English Professor
HeartWare Inc March 2010 - Present
Skeletal Dynamics, LLC June 2009 - November 2009
Cordis a Johnson and Johnson Co. April 1996 - December 2007
Cordis, Johnson & Johnson 1998 - 2007
Cordis Endovacular, Johnson & Johnson 1996 - 2007
Cordis Corp. 1995 - 2007
Skills
Product Development, Medical Devices, Design Control, ISO 13485, CAPA, V&V, FDA, Biomedical Engineering, Validation, Design of Experiments, Quality System, Minitab, Manufacturing, ISO 14971, R&D, GMP, Lean Manufacturing, Quality Assurance
Education
Miami Dade College 1996 — 2000
Associate of Science (A.S.), Electronic Engineering Technology
Manuel Ascunze Pedagogical School Cuba 1988 — 1993
BS, English Professor
Randy Krueger's HeartWare Inc Experience January 2012 - Present
Job Sr. Engineering Manager at Edwards Lifesciences
Industry Medical Devices
Experience
Edwards Lifesciences June 2014 - Present
HeartWare Inc January 2012 - Present
Skills
Medical Devices, Six Sigma, Cross-functional Team..., Process Improvement, Product Development, Continuous Improvement, Manufacturing, Lean Manufacturing, Quality System, Strategic Planning, Project Management, Team Building, FDA, Product Launch, Product Management, Quality Assurance, Minitab, Forecasting, ISO 13485, Operations Management, Supply Chain, Management, Start-ups, Program Management, Design of Experiments, SAP, Leadership, Project Planning
Education
Nova Southeastern University 2003 — 2005
MBA, Finance
University of Minnesota-Twin Cities 1987 — 1990
BS, Mechanical / Industrial Engineering
University of Wisconsin-Madison 1980 — 1984
BS, Meteorology
Edwards Lifesciences June 2014 - Present
HeartWare Inc January 2012 - Present
Skills
Medical Devices, Six Sigma, Cross-functional Team..., Process Improvement, Product Development, Continuous Improvement, Manufacturing, Lean Manufacturing, Quality System, Strategic Planning, Project Management, Team Building, FDA, Product Launch, Product Management, Quality Assurance, Minitab, Forecasting, ISO 13485, Operations Management, Supply Chain, Management, Start-ups, Program Management, Design of Experiments, SAP, Leadership, Project Planning
Education
Nova Southeastern University 2003 — 2005
MBA, Finance
University of Minnesota-Twin Cities 1987 — 1990
BS, Mechanical / Industrial Engineering
University of Wisconsin-Madison 1980 — 1984
BS, Meteorology
Patricia Irish's HeartWare Inc Experience May 2013 - Present
Job CAPA Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc May 2013 - Present
University of Miami Tissue Bank September 2012 - May 2013
Boston Scientific September 1993 - December 2011
Medcanica LLC 1999 - 2000
Symbiosis Corp. 1990 - 1993
Skills
Design Control, ISO 13485, Medical Devices, CAPA, FDA, V&V, Biomedical Engineering, ISO 14971, Quality System, Design of Experiments, Validation, FMEA, GMP, Change Control, Root Cause Analysis, Manufacturing, Quality Assurance, Quality Management, R&D
Education
Rensselaer Polytechnic Institute 1986 — 1990
BS, Biomedical Engineering
HeartWare Inc May 2013 - Present
University of Miami Tissue Bank September 2012 - May 2013
Boston Scientific September 1993 - December 2011
Medcanica LLC 1999 - 2000
Symbiosis Corp. 1990 - 1993
Skills
Design Control, ISO 13485, Medical Devices, CAPA, FDA, V&V, Biomedical Engineering, ISO 14971, Quality System, Design of Experiments, Validation, FMEA, GMP, Change Control, Root Cause Analysis, Manufacturing, Quality Assurance, Quality Management, R&D
Education
Rensselaer Polytechnic Institute 1986 — 1990
BS, Biomedical Engineering
Lisa Ensz's HeartWare Inc Experience March 2008 - Present
Job Global Product Director at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2008 - Present
Boston Scientific August 2004 - March 2008
Cyveillance 2000 - 2002
Education
The Tuck School of Business at Dartmouth 2002 — 2004
MBA
Johns Hopkins Bloomberg School of Public Health 1996 — 1997
MPH, Health Policy & Management
University of Richmond 1990 — 1994
BS, Biology
HeartWare Inc March 2008 - Present
Boston Scientific August 2004 - March 2008
Cyveillance 2000 - 2002
Education
The Tuck School of Business at Dartmouth 2002 — 2004
MBA
Johns Hopkins Bloomberg School of Public Health 1996 — 1997
MPH, Health Policy & Management
University of Richmond 1990 — 1994
BS, Biology
Pamela Mallek McKenna's HeartWare Inc Experience June 2011 - Present
Job Senior CRA Manager at HeartWare Inc
Industry Pharmaceuticals
Experience
HeartWare Inc June 2011 - Present
HeartWare Inc May 2010 - June 2011
i3 Research providing service to Merck April 2010 - August 2010
Bard Peripheral Vascular October 2005 - December 2009
Johnson & Johnson November 2007 - January 2009
Kensey Nash Corporation August 2005 - December 2005
Quintiles October 2004 - October 2005
Eli Lilly March 2002 - October 2004
Quintiles November 2000 - March 2002
ICON Clinical Research October 1998 - October 2000
Skills
Clinical Trials
Education
University of Illinois at Urbana-Champaign 1992 — 1996
BS, Animal Sciences
HeartWare Inc June 2011 - Present
HeartWare Inc May 2010 - June 2011
i3 Research providing service to Merck April 2010 - August 2010
Bard Peripheral Vascular October 2005 - December 2009
Johnson & Johnson November 2007 - January 2009
Kensey Nash Corporation August 2005 - December 2005
Quintiles October 2004 - October 2005
Eli Lilly March 2002 - October 2004
Quintiles November 2000 - March 2002
ICON Clinical Research October 1998 - October 2000
Skills
Clinical Trials
Education
University of Illinois at Urbana-Champaign 1992 — 1996
BS, Animal Sciences
Anne Cannon RN, BSN's HeartWare Inc Experience September 2012 - Present
Job Clinical Specialist at HeartWare Inc
Industry Hospital & Health Care
Experience
HeartWare Inc September 2012 - Present
University of Colorado Hospital May 1990 - October 2012
Skills
Healthcare, Hospitals, Clinical Research, Nursing, Critical Care, ICU, Healthcare Management, EMR, BLS, Acute Care, Healthcare Information..., Medicine, Medical Devices, Patient Safety, Surgery, ACLS, Cardiology, Patient Education, Clinical Trials, Transplant
Education
foothill high school 1980 — 1984
Regis University
Registered Nursing/Registered Nurse
HeartWare Inc September 2012 - Present
University of Colorado Hospital May 1990 - October 2012
Skills
Healthcare, Hospitals, Clinical Research, Nursing, Critical Care, ICU, Healthcare Management, EMR, BLS, Acute Care, Healthcare Information..., Medicine, Medical Devices, Patient Safety, Surgery, ACLS, Cardiology, Patient Education, Clinical Trials, Transplant
Education
foothill high school 1980 — 1984
Regis University
Registered Nursing/Registered Nurse
Lauren (Zwicky) Vickery, MPH's HeartWare Inc Experience January 2012 - June 2012
Job Senior Global Clinical Operations Lead at Novartis
Industry Biotechnology
Experience
Novartis April 2015 - Present
Novartis December 2012 - Present
HeartWare Inc January 2012 - June 2012
Sirtris Pharma-A GSK-owned Co. October 2010 - January 2012
Sanofi Pasteur June 2008 - October 2010
Facet Solutions Inc. 2007 - 2008
Yale School of Medicine/Yale Griffin Prevention Research Center September 2005 - April 2007
University of Vermont School of Medicine/Fletcher Allen Health Care September 2003 - September 2005
Skills
Vaccines, Clinical Trials, CTMS, Medical Devices, Clinical Development, Biotechnology, Pharmaceutical Industry, EDC, GCP, CRO, Clinical Monitoring, Clinical Research, FDA, Infectious Diseases, Clinical Data Management, Human Nutrition, Personal Training, Exercise Physiology, ICH-GCP, Drug Development, Diabetes
Education
Yale School of Public Health 2005 — 2007
MPH, Public Health
Skidmore College 1999 — 2003
BS, Exercise Science
Novartis April 2015 - Present
Novartis December 2012 - Present
HeartWare Inc January 2012 - June 2012
Sirtris Pharma-A GSK-owned Co. October 2010 - January 2012
Sanofi Pasteur June 2008 - October 2010
Facet Solutions Inc. 2007 - 2008
Yale School of Medicine/Yale Griffin Prevention Research Center September 2005 - April 2007
University of Vermont School of Medicine/Fletcher Allen Health Care September 2003 - September 2005
Skills
Vaccines, Clinical Trials, CTMS, Medical Devices, Clinical Development, Biotechnology, Pharmaceutical Industry, EDC, GCP, CRO, Clinical Monitoring, Clinical Research, FDA, Infectious Diseases, Clinical Data Management, Human Nutrition, Personal Training, Exercise Physiology, ICH-GCP, Drug Development, Diabetes
Education
Yale School of Public Health 2005 — 2007
MPH, Public Health
Skidmore College 1999 — 2003
BS, Exercise Science
Mary Jacoski's HeartWare Inc Experience March 2014 - Present
Job Associate Director, Medical Sciences / Medical Affairs at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2014 - Present
HeartWare Inc. December 2011 - April 2014
Boston Scientific January 2007 - December 2011
TAM Cardiovascular Clinical Research Consortium, University of Tennessee May 2000 - December 2006
Rhone-Poulenc Rorer/Aventis January 1998 - April 2000
Rhone-Poulenc Rorer January 1996 - January 1998
Rhone-Poulenc Rorer October 1993 - January 1996
Rhone-Poulenc Rorer April 1990 - September 1993
Milton S. Hershey Medical Center January 1988 - January 1990
Geisinger Medical Center January 1984 - January 1985
Skills
Sop, Project Management, Leadership, Data Analysis, Training, Due Diligence, Project Planning, Functional Requirements, Editing, Medical Writing, Cardiology, Medical Devices, SOP, Protocol, Clinical Trials, FDA
Education
Pennsylvania State University College of Medicine 1987 — 1990
MS, CMB & Biochemistry
University of Scranton 1983 — 1987
BS, BioPhysics
HeartWare Inc March 2014 - Present
HeartWare Inc. December 2011 - April 2014
Boston Scientific January 2007 - December 2011
TAM Cardiovascular Clinical Research Consortium, University of Tennessee May 2000 - December 2006
Rhone-Poulenc Rorer/Aventis January 1998 - April 2000
Rhone-Poulenc Rorer January 1996 - January 1998
Rhone-Poulenc Rorer October 1993 - January 1996
Rhone-Poulenc Rorer April 1990 - September 1993
Milton S. Hershey Medical Center January 1988 - January 1990
Geisinger Medical Center January 1984 - January 1985
Skills
Sop, Project Management, Leadership, Data Analysis, Training, Due Diligence, Project Planning, Functional Requirements, Editing, Medical Writing, Cardiology, Medical Devices, SOP, Protocol, Clinical Trials, FDA
Education
Pennsylvania State University College of Medicine 1987 — 1990
MS, CMB & Biochemistry
University of Scranton 1983 — 1987
BS, BioPhysics
Leticia Triana's HeartWare Inc Experience September 2008 - Present
Job Inventory and Materials Management Sr.Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc September 2008 - Present
Boston Scientific August 2004 - September 2008
Cordis 2000 - 2004
Skills
CAPA, FDA, Medical Devices, Design Control, V&V, Quality System, GMP, Lean Manufacturing, DMAIC, Validation, QAD, SAP, Microsoft Office, Inventory Management, Team Leadership, Root Cause Analysis, Manufacturing, Continuous Improvement, Quality Assurance
Education
University of Miami 1997 — 2000
Master's degree, Industrial Engineering
HeartWare Inc September 2008 - Present
Boston Scientific August 2004 - September 2008
Cordis 2000 - 2004
Skills
CAPA, FDA, Medical Devices, Design Control, V&V, Quality System, GMP, Lean Manufacturing, DMAIC, Validation, QAD, SAP, Microsoft Office, Inventory Management, Team Leadership, Root Cause Analysis, Manufacturing, Continuous Improvement, Quality Assurance
Education
University of Miami 1997 — 2000
Master's degree, Industrial Engineering
Katrin Leadley, MD's HeartWare Inc Experience August 2014 - Present
Job Chief Medical Officer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc August 2014 - Present
JenaValve GmbH March 2011 - August 2014
Boston Scientific October 2003 - March 2011
Advanced Stent Technologies May 2002 - September 2003
Pulmonx July 2001 - April 2002
Skills
Clinical Development, Clinical Trial..., Cardiology, Clinical, Medical Devices, GCP, Regulatory Affairs, Clinical Research, Clinical Trials, Life Sciences, FDA, Pharmacovigilance, Protocol Development, Surgery, Medical Writing, CTMS, Medical Device R&D, Lifesciences
Education
Ludwig-Maximilians Universität München
MD
HeartWare Inc August 2014 - Present
JenaValve GmbH March 2011 - August 2014
Boston Scientific October 2003 - March 2011
Advanced Stent Technologies May 2002 - September 2003
Pulmonx July 2001 - April 2002
Skills
Clinical Development, Clinical Trial..., Cardiology, Clinical, Medical Devices, GCP, Regulatory Affairs, Clinical Research, Clinical Trials, Life Sciences, FDA, Pharmacovigilance, Protocol Development, Surgery, Medical Writing, CTMS, Medical Device R&D, Lifesciences
Education
Ludwig-Maximilians Universität München
MD
Alex Guerra's HeartWare Inc Experience February 2010 - Present
Job QA Failure Analyst, HeartWare, Inc
Industry Medical Devices
Experience
HeartWare Inc February 2010 - Present
HeartWare Inc February 2010 - June 2014
Skills
Biomedical Engineering, CAPA, Cross-functional Team..., FDA, GMP, Medical Devices, Quality Assurance, Quality System, Six Sigma, V&V, Validation, Design Control, ISO 14971, Design of Experiments, ISO 13485, Minitab, Quality Auditing, Testing
Education
Miami Dade College
HeartWare Inc February 2010 - Present
HeartWare Inc February 2010 - June 2014
Skills
Biomedical Engineering, CAPA, Cross-functional Team..., FDA, GMP, Medical Devices, Quality Assurance, Quality System, Six Sigma, V&V, Validation, Design Control, ISO 14971, Design of Experiments, ISO 13485, Minitab, Quality Auditing, Testing
Education
Miami Dade College
Jorge Benard's HeartWare Inc Experience October 2007 - Present
Job Sr. Manufaturing Tech at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc October 2007 - Present
Education
Miami Dade College 1989 — 1991
HeartWare Inc October 2007 - Present
Education
Miami Dade College 1989 — 1991
Dennis Vaughn's HeartWare Inc Experience January 2012 - Present
Job Contract Validation Engineer at Heartware, Inc
Industry Medical Devices
Experience
Heartware, Inc January 2012 - Present
Boston Scientific October 2009 - December 2011
GatorTeknica May 2008 - October 2009
Implant Logics February 2008 - May 2008
Angiotech December 2006 - February 2007
3D Medical Manufacturing, Inc. 2003 - 2006
Micro Med Engineering September 1997 - June 2003
Cordis / Telectronics Pacing System May 1992 - 1997
Cordis Corporation 1986 - 1992
Skills
ISO 13485, Process Validation, Quality Systems, Medical Devices, Quality Assurance, ISO, Manufacturing, Machining, ISO 14971, CAPA, Validations, Gage R&R, Quality Engineering, Quality Auditing, Process Capability
Education
University of Florida
Bachelor's degree, Industrial Engineering
Heartware, Inc January 2012 - Present
Boston Scientific October 2009 - December 2011
GatorTeknica May 2008 - October 2009
Implant Logics February 2008 - May 2008
Angiotech December 2006 - February 2007
3D Medical Manufacturing, Inc. 2003 - 2006
Micro Med Engineering September 1997 - June 2003
Cordis / Telectronics Pacing System May 1992 - 1997
Cordis Corporation 1986 - 1992
Skills
ISO 13485, Process Validation, Quality Systems, Medical Devices, Quality Assurance, ISO, Manufacturing, Machining, ISO 14971, CAPA, Validations, Gage R&R, Quality Engineering, Quality Auditing, Process Capability
Education
University of Florida
Bachelor's degree, Industrial Engineering
Heather Meterparel's HeartWare Inc Experience January 2013 - Present
Job Executive Assistant at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2013 - Present
Genzyme Corp. March 2000 - January 2013
Alltel 1998 - 2000
Skills
Talent Management, Biotechnology, Onboarding, Succession Planning, Human Resources, Employee Relations, HRIS, PeopleSoft, Applicant Tracking..., Deferred Compensation
Education
Ithaca College 1990 — 1994
HeartWare Inc January 2013 - Present
Genzyme Corp. March 2000 - January 2013
Alltel 1998 - 2000
Skills
Talent Management, Biotechnology, Onboarding, Succession Planning, Human Resources, Employee Relations, HRIS, PeopleSoft, Applicant Tracking..., Deferred Compensation
Education
Ithaca College 1990 — 1994
Mairi MacLean's HeartWare Inc Experience June 2014 - Present
Job Senior Program Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc June 2014 - Present
HeartWare Inc June 2010 - May 2014
ITW Dynatec 1998 - 2008
Videojet 1996 - 1998
Videojet 1993 - 1996
Videojet 1989 - 1993
Ferranti Navagation Systems 1985 - 1989
Skills
Coaching, Medical Devices, Product Launch, SPC
Education
Keller Graduate School of Management of DeVry University 1995 — 1999
MBA
University of Strathclyde 1980 — 1984
BSc (Hons), Mechanical Engineering
HeartWare Inc June 2014 - Present
HeartWare Inc June 2010 - May 2014
ITW Dynatec 1998 - 2008
Videojet 1996 - 1998
Videojet 1993 - 1996
Videojet 1989 - 1993
Ferranti Navagation Systems 1985 - 1989
Skills
Coaching, Medical Devices, Product Launch, SPC
Education
Keller Graduate School of Management of DeVry University 1995 — 1999
MBA
University of Strathclyde 1980 — 1984
BSc (Hons), Mechanical Engineering
Jon Hardy's HeartWare Inc Experience February 2013 - September 2014
Job Sr Electrical Engineer at BiOM®
Industry Medical Devices
Experience
BiOM® September 2014 - Present
HeartWare Inc February 2013 - September 2014
HeartWare Inc March 2011 - February 2013
Ximedica June 2010 - April 2011
Haemonetics June 2006 - June 2010
Draper Laboratory June 2005 - May 2006
Skills
Medical Devices, ISO 13485, PCB design, Design Control, Embedded Systems, Product Development, Circuit Design, Electrical Engineering, VHDL, Simulations, Labview, Design for Manufacturing, Engineering Management, Electronics, FMEA, PCB Design
Education
UMass Lowell 2009 — 2013
MS, Electrical and Electronics Engineering
Northeastern University 2002 — 2007
Bachelors of Science, Electrical Engineering
BiOM® September 2014 - Present
HeartWare Inc February 2013 - September 2014
HeartWare Inc March 2011 - February 2013
Ximedica June 2010 - April 2011
Haemonetics June 2006 - June 2010
Draper Laboratory June 2005 - May 2006
Skills
Medical Devices, ISO 13485, PCB design, Design Control, Embedded Systems, Product Development, Circuit Design, Electrical Engineering, VHDL, Simulations, Labview, Design for Manufacturing, Engineering Management, Electronics, FMEA, PCB Design
Education
UMass Lowell 2009 — 2013
MS, Electrical and Electronics Engineering
Northeastern University 2002 — 2007
Bachelors of Science, Electrical Engineering
Shane Pickering's HeartWare Inc Experience October 2013 - Present
Job Territory Manager Heartware Inc.
Industry Medical Devices
Experience
HeartWare Inc October 2013 - Present
Boston Scientific January 2002 - October 2013
DHL Express April 1994 - January 2002
United States Army Reserve February 1988 - February 1996
Skills
Capital Equipment, Competitive Analysis, Operating Room, Market Research, Sales Operations, Medical Devices, Disposables, Sales Management, Interventional Radiology, Sales Effectiveness, New Business Development, Surgery, Sales, Contract Negotiation, Cross-functional Team..., Leadership, Business Development, Management
Education
Missouri State University 1989 — 1993
B.S. Business Administration, Marketing Management
HeartWare Inc October 2013 - Present
Boston Scientific January 2002 - October 2013
DHL Express April 1994 - January 2002
United States Army Reserve February 1988 - February 1996
Skills
Capital Equipment, Competitive Analysis, Operating Room, Market Research, Sales Operations, Medical Devices, Disposables, Sales Management, Interventional Radiology, Sales Effectiveness, New Business Development, Surgery, Sales, Contract Negotiation, Cross-functional Team..., Leadership, Business Development, Management
Education
Missouri State University 1989 — 1993
B.S. Business Administration, Marketing Management
Michelle Cochran's HeartWare Inc Experience August 2011 - July 2013
Job Tax Manager at Public Consulting Group
Industry Accounting
Experience
Public Consulting Group May 2015 - Present
HeartWare Inc August 2011 - July 2013
UniFirst Corporation February 2009 - August 2011
Costantino Richards Rizzo, LLP 2007 - 2008
Shire Pharmaceuticals 2006 - 2007
Ernst & Young 2002 - 2006
Ernst & Young 1999 - 2002
Skills
SEC filings, Corporate Tax, Accounting, Auditing, International Tax, Financial Reporting, Tax Advisory, General Ledger, Tax Research, Tax Preparation, Sarbanes-Oxley Act, US GAAP, GAAP, Financial Analysis, Income Tax, Tax, CPA, Internal Controls, Financial Accounting, Forecasting, Sarbanes-Oxley, Financial Statements, VAT, Transfer Pricing, Research & Development..., Cross-border..., Intercompany..., Tax Accounting
Education
Northeastern University
Masters, Taxation
Suffolk University - Sawyer Business School
BSBA, Accounting
Public Consulting Group May 2015 - Present
HeartWare Inc August 2011 - July 2013
UniFirst Corporation February 2009 - August 2011
Costantino Richards Rizzo, LLP 2007 - 2008
Shire Pharmaceuticals 2006 - 2007
Ernst & Young 2002 - 2006
Ernst & Young 1999 - 2002
Skills
SEC filings, Corporate Tax, Accounting, Auditing, International Tax, Financial Reporting, Tax Advisory, General Ledger, Tax Research, Tax Preparation, Sarbanes-Oxley Act, US GAAP, GAAP, Financial Analysis, Income Tax, Tax, CPA, Internal Controls, Financial Accounting, Forecasting, Sarbanes-Oxley, Financial Statements, VAT, Transfer Pricing, Research & Development..., Cross-border..., Intercompany..., Tax Accounting
Education
Northeastern University
Masters, Taxation
Suffolk University - Sawyer Business School
BSBA, Accounting
Robert Yocher's HeartWare Inc Experience June 2011 - Present
Job Senior Vice President Regulatory Affairs at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc June 2011 - Present
Regulatory Affairs Professionals Society (RAPS) 2010 - 2015
Regis College 2002 - 2014
Genzyme March 1999 - March 2011
Dornier MedTech 1990 - 1993
Skills
Medical Devices, Biotechnology, Personalized Medicine, Regulatory Affairs, Diagnostics, Life Sciences, Microbiology, Biomedical Engineering, Biochemistry, Clinical Trials, GMP, CAPA, ISO 13485, Clinical Research, cGMP, GCP, Quality Systems, FDA, Lifesciences, Hardware Diagnostics, Quality Auditing, Quality System, Quality Assurance, Regulatory Submissions, Validation, Oncology, Biopharmaceuticals, Sop, Design Control, Clinical Development, Technology Transfer, Change Control, Pharmaceutical Industry, Laboratory, GLP, R&D, V&V, Infectious Diseases, Immunology, Commercialization, CTMS, Assay Development, SOP
Education
Quinnipiac University 1973 — 1975
M.H. Sc, Public Health and Epidemiology/Medical Laboratory Sciences
University of Connecticut 1968 — 1972
B. A., Microbiology/Biochemistry
HeartWare Inc June 2011 - Present
Regulatory Affairs Professionals Society (RAPS) 2010 - 2015
Regis College 2002 - 2014
Genzyme March 1999 - March 2011
Dornier MedTech 1990 - 1993
Skills
Medical Devices, Biotechnology, Personalized Medicine, Regulatory Affairs, Diagnostics, Life Sciences, Microbiology, Biomedical Engineering, Biochemistry, Clinical Trials, GMP, CAPA, ISO 13485, Clinical Research, cGMP, GCP, Quality Systems, FDA, Lifesciences, Hardware Diagnostics, Quality Auditing, Quality System, Quality Assurance, Regulatory Submissions, Validation, Oncology, Biopharmaceuticals, Sop, Design Control, Clinical Development, Technology Transfer, Change Control, Pharmaceutical Industry, Laboratory, GLP, R&D, V&V, Infectious Diseases, Immunology, Commercialization, CTMS, Assay Development, SOP
Education
Quinnipiac University 1973 — 1975
M.H. Sc, Public Health and Epidemiology/Medical Laboratory Sciences
University of Connecticut 1968 — 1972
B. A., Microbiology/Biochemistry
Brad Sparlin's HeartWare Inc Experience April 2012 - Present
Job North America Western Regional Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc April 2012 - Present
HeartWare Inc April 2011 - June 2012
St. Jude Medical 2001 - April 2011
Genzyme Biosurgery 1999 - 2001
Skills
Medical Devices, Business Development, Strategic Planning, Operating Room, Interventional..., Surgery, Business Strategy, Sales Management, Management, Capital Equipment, Product Launch, Market Development, Surgeons, Sales Operations, Cardiology, Cath Lab, Healthcare
Education
The University of New Mexico
BS, Exercise Physiology
HeartWare Inc April 2012 - Present
HeartWare Inc April 2011 - June 2012
St. Jude Medical 2001 - April 2011
Genzyme Biosurgery 1999 - 2001
Skills
Medical Devices, Business Development, Strategic Planning, Operating Room, Interventional..., Surgery, Business Strategy, Sales Management, Management, Capital Equipment, Product Launch, Market Development, Surgeons, Sales Operations, Cardiology, Cath Lab, Healthcare
Education
The University of New Mexico
BS, Exercise Physiology
Lauren Padron's HeartWare Inc Experience September 2014 - Present
Job Commercial Operations Support Supervisor, HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc September 2014 - Present
HeartWare Inc February 2013 - September 2014
HeartWare Inc October 2010 - February 2013
Berman Rennert Vogel & Mandler P.A. March 2010 - October 2010
Priority One CU September 2008 - March 2010
Power Financial Credit Union November 2005 - September 2008
Skills
Medical Devices, Cross-functional Team..., FDA, Process Improvement, Microsoft Excel, Microsoft Office, Customer Service, Quality Assurance, Manufacturing, Continuous Improvement, Product Development, Quality System, Six Sigma, Lean Manufacturing, Validation, ISO 13485
Education
Nova Southeastern University 2011 — 2012
M.B.A., Global Management
Florida International University - College of Business Administration 2007 — 2010
BA, International Business
HeartWare Inc September 2014 - Present
HeartWare Inc February 2013 - September 2014
HeartWare Inc October 2010 - February 2013
Berman Rennert Vogel & Mandler P.A. March 2010 - October 2010
Priority One CU September 2008 - March 2010
Power Financial Credit Union November 2005 - September 2008
Skills
Medical Devices, Cross-functional Team..., FDA, Process Improvement, Microsoft Excel, Microsoft Office, Customer Service, Quality Assurance, Manufacturing, Continuous Improvement, Product Development, Quality System, Six Sigma, Lean Manufacturing, Validation, ISO 13485
Education
Nova Southeastern University 2011 — 2012
M.B.A., Global Management
Florida International University - College of Business Administration 2007 — 2010
BA, International Business
Frederick Michael McNeil's HeartWare Inc Experience September 2013 - Present
Job Global Healthcare Initiatives Manager at HeartWare
Industry Hospital & Health Care
Experience
HeartWare Inc September 2013 - Present
Complex Care Solutions July 2014 - July 2015
HeartWare Inc October 2011 - September 2013
Oregon Health and Science University June 2008 - October 2011
University of Rochester June 2005 - May 2008
Skills
Nursing, Critical Care, ACLS, ICU, BLS, Nursing Education, Acute Care, Inpatient, Patient Safety, Hospitals, Patient Education, Nurse Practitioners, Clinical Research, Telemetry, Patient Advocacy, Healthcare, Epic Systems, EMR, Healthcare Management, Medical Devices
Education
Oregon Health and Science University 2008 — 2011
DNP, Doctor of Nursing Practice, Nursing
University of Rochester 2005 — 2008
MS, Acute Care Nurse Practitioner, Critical Care, Cardiovascular
University of Colorado Colorado Springs 2002 — 2005
BS, Nursing
HeartWare Inc September 2013 - Present
Complex Care Solutions July 2014 - July 2015
HeartWare Inc October 2011 - September 2013
Oregon Health and Science University June 2008 - October 2011
University of Rochester June 2005 - May 2008
Skills
Nursing, Critical Care, ACLS, ICU, BLS, Nursing Education, Acute Care, Inpatient, Patient Safety, Hospitals, Patient Education, Nurse Practitioners, Clinical Research, Telemetry, Patient Advocacy, Healthcare, Epic Systems, EMR, Healthcare Management, Medical Devices
Education
Oregon Health and Science University 2008 — 2011
DNP, Doctor of Nursing Practice, Nursing
University of Rochester 2005 — 2008
MS, Acute Care Nurse Practitioner, Critical Care, Cardiovascular
University of Colorado Colorado Springs 2002 — 2005
BS, Nursing
James Patak's HeartWare Inc Experience January 2010 - Present
Job Project Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2010 - Present
Southern Cross Professional Services January 1998 - January 2010
Invivo Corporation, a Philips Medical Systems Company May 2009 - December 2009
HeartWare Inc May 2008 - April 2009
NPE September 2008 - January 2009
Abbott Diagnostics 2007 - 2008
Trade Staffers Inc. February 2002 - 2007
Cordis Corporation, a Johnson and Johnson Company 1990 - 2004
Cordis September 1998 - January 2001
Cordis Corporation 1990 - 1998
Skills
Inventory Management, Medical Devices, CAPA, Design Control, ISO 13485, Quality System, FDA, Six Sigma, Cross-functional Team..., V&V, Product Development, Commercialization, Product Launch, Manufacturing, Pharmaceutical Industry, Quality Assurance, Validation, Regulatory Submissions, Change Control, Regulatory Affairs, Continuous Improvement, Testing, DMAIC, Root Cause Analysis, Design of Experiments, GMP, 21 CFR Part 11, Quality Control, ISO, R&D, Software Documentation, Minitab, Quality Auditing, Quality Management, FMEA, Biomedical Engineering, Process Simulation, Sop, SPC, Lean Manufacturing, Technology Transfer, Computer System..., Process Engineering, Design for Manufacturing, Biotechnology, CE marking, Manufacturing..., Clinical Trials, ISO 14971, Lifesciences
Education
New York Institute of Technology 1978 — 1981
BS, Engineering Technology
State University of New York - System 1975 — 1977
AAS, Veterinary Sciences
HeartWare Inc January 2010 - Present
Southern Cross Professional Services January 1998 - January 2010
Invivo Corporation, a Philips Medical Systems Company May 2009 - December 2009
HeartWare Inc May 2008 - April 2009
NPE September 2008 - January 2009
Abbott Diagnostics 2007 - 2008
Trade Staffers Inc. February 2002 - 2007
Cordis Corporation, a Johnson and Johnson Company 1990 - 2004
Cordis September 1998 - January 2001
Cordis Corporation 1990 - 1998
Skills
Inventory Management, Medical Devices, CAPA, Design Control, ISO 13485, Quality System, FDA, Six Sigma, Cross-functional Team..., V&V, Product Development, Commercialization, Product Launch, Manufacturing, Pharmaceutical Industry, Quality Assurance, Validation, Regulatory Submissions, Change Control, Regulatory Affairs, Continuous Improvement, Testing, DMAIC, Root Cause Analysis, Design of Experiments, GMP, 21 CFR Part 11, Quality Control, ISO, R&D, Software Documentation, Minitab, Quality Auditing, Quality Management, FMEA, Biomedical Engineering, Process Simulation, Sop, SPC, Lean Manufacturing, Technology Transfer, Computer System..., Process Engineering, Design for Manufacturing, Biotechnology, CE marking, Manufacturing..., Clinical Trials, ISO 14971, Lifesciences
Education
New York Institute of Technology 1978 — 1981
BS, Engineering Technology
State University of New York - System 1975 — 1977
AAS, Veterinary Sciences
Lita Waggoner-Pogue, MD, RAC's HeartWare Inc Experience September 2011 - Present
Job Consultant at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc September 2011 - Present
Regulatory Affairs and Clinical Safety January 2011 - Present
Northeastern University April 2009 - Present
Organogenesis 2006 - 2009
Waters 2005 - 2006
Intertech Engineering October 2000 - August 2005
Massachusetts Poison Information Center 1984 - 1986
Skills
Lifesciences, FDA, Regulatory Affairs, Medical Devices, Pharmacovigilance, Biotechnology, Pharmaceutical Industry, Validation, Clinical Research, Clinical Trials, Regulatory Submissions, GCP, Quality Assurance, Oncology, Medical Writing, Chemistry, GMP, MDR, MedDRA, clinical safety, WHO Drug Dictionary..., Medical Device Vigilance, Medical Information, Clinical Literature..., ISO 10993, Human Factors, Risk Management, Toxicology, Field Actions and..., IEC 62366, EMA, Life Sciences
Education
Drug Information Association 2011 — 2012
Pharmacovigilance Certificate, Drug Safety/Pharmacovigilance
Trained MedDRA Coder. MSSO 2011 — 2012
SMQs and MedDRA Coding, MedDRA Training; SMQ Training
Trained CRA 2011 — 2011
University of Massachusetts Medical School 2009 — 2011
MPH in process, Master Public Health Epidemiology
University of Illinois College of Medicine 1979 — 1983
MD, Medicine
Northern Illinois University 1975 — 1979
BS, Molecular Biology
DIA
Certificate in Medical Communications
Drug Information Association
Medical Communications Certificate, Medical Information
HeartWare Inc September 2011 - Present
Regulatory Affairs and Clinical Safety January 2011 - Present
Northeastern University April 2009 - Present
Organogenesis 2006 - 2009
Waters 2005 - 2006
Intertech Engineering October 2000 - August 2005
Massachusetts Poison Information Center 1984 - 1986
Skills
Lifesciences, FDA, Regulatory Affairs, Medical Devices, Pharmacovigilance, Biotechnology, Pharmaceutical Industry, Validation, Clinical Research, Clinical Trials, Regulatory Submissions, GCP, Quality Assurance, Oncology, Medical Writing, Chemistry, GMP, MDR, MedDRA, clinical safety, WHO Drug Dictionary..., Medical Device Vigilance, Medical Information, Clinical Literature..., ISO 10993, Human Factors, Risk Management, Toxicology, Field Actions and..., IEC 62366, EMA, Life Sciences
Education
Drug Information Association 2011 — 2012
Pharmacovigilance Certificate, Drug Safety/Pharmacovigilance
Trained MedDRA Coder. MSSO 2011 — 2012
SMQs and MedDRA Coding, MedDRA Training; SMQ Training
Trained CRA 2011 — 2011
University of Massachusetts Medical School 2009 — 2011
MPH in process, Master Public Health Epidemiology
University of Illinois College of Medicine 1979 — 1983
MD, Medicine
Northern Illinois University 1975 — 1979
BS, Molecular Biology
DIA
Certificate in Medical Communications
Drug Information Association
Medical Communications Certificate, Medical Information
Deborah Pinto's HeartWare Inc Experience November 2009 - Present
Job at HeartWare Inc
Industry Warehousing
Experience
HeartWare Inc November 2009 - Present
HeartWare Inc November 2009 - February 2011
Hydraulic Supply October 2006 - August 2009
Hydraulic Supply 2006 - 2009
All Points Screw Bolt & Specialty August 2005 - October 2006
ITW Buildex October 1992 - August 2005
ITW/Ramset October 1989 - November 1992
Deborah Pinto August 1987 - October 1989
Thor Services March 1986 - August 1987
Hanes Hosiery June 1984 - March 1986
Skills
Training, Inventory Management, Logistics, Management, Cross-functional Team..., Leadership, Program Management, Process Improvement, Forecasting, Supply Chain, Team Building, Materials, Microsoft Excel, Manufacturing, Product Development, Purchasing, Medical Devices, Performance Management, Sales
Education
Pepperdine University 1984 — 1986
Masters, Business Administration
University of Dayton 1971 — 1973
Bachelor of Science, Secondary Education
Marymount University 1969 — 1971
AA, Liberal Arts
HeartWare Inc November 2009 - Present
HeartWare Inc November 2009 - February 2011
Hydraulic Supply October 2006 - August 2009
Hydraulic Supply 2006 - 2009
All Points Screw Bolt & Specialty August 2005 - October 2006
ITW Buildex October 1992 - August 2005
ITW/Ramset October 1989 - November 1992
Deborah Pinto August 1987 - October 1989
Thor Services March 1986 - August 1987
Hanes Hosiery June 1984 - March 1986
Skills
Training, Inventory Management, Logistics, Management, Cross-functional Team..., Leadership, Program Management, Process Improvement, Forecasting, Supply Chain, Team Building, Materials, Microsoft Excel, Manufacturing, Product Development, Purchasing, Medical Devices, Performance Management, Sales
Education
Pepperdine University 1984 — 1986
Masters, Business Administration
University of Dayton 1971 — 1973
Bachelor of Science, Secondary Education
Marymount University 1969 — 1971
AA, Liberal Arts
Martha A Moreno's HeartWare Inc Experience July 2012 - December 2012
Job Quality Systems Engineer / Supervisor at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical August 2013 - Present
Aveva Drug Delivery Systems May 2013 - August 2013
HeartWare Inc July 2012 - December 2012
Safestitch Medical February 2012 - June 2012
Boston Scientific March 2010 - January 2012
Dayton-Granger, Inc. October 2007 - August 2009
Dayton-Granger, Inc. October 2006 - October 2007
Skills
Quality System, Quality Assurance, Lean Manufacturing, Root Cause Analysis, CAPA, FDA, V&V, Validation, Minitab, Engineering Drawings, FMEA, Value Stream Mapping, Manufacturing, Six Sigma, DMAIC, Engineering, Manufacturing..., Quality Control, Cross-functional Team..., Team Leadership, ISO, SAP, Supervisory Skills, MRP, Equipment Qualification, Process Validation, Creative Problem Solving, Initiator, Multitasker
Education
Polytechnic University of Puerto Rico 2011 — 2015
M.S. in Engineering Management, Manufacturing Engineering, 3.85
Unilatina International College 2006 — 2007
Diploma Program, Small Business Management
Universidad Industrial de Santander 2001 — 2005
Bachelor of Science (B.S.), Industrial Engineering, 4.0
Bolton Medical August 2013 - Present
Aveva Drug Delivery Systems May 2013 - August 2013
HeartWare Inc July 2012 - December 2012
Safestitch Medical February 2012 - June 2012
Boston Scientific March 2010 - January 2012
Dayton-Granger, Inc. October 2007 - August 2009
Dayton-Granger, Inc. October 2006 - October 2007
Skills
Quality System, Quality Assurance, Lean Manufacturing, Root Cause Analysis, CAPA, FDA, V&V, Validation, Minitab, Engineering Drawings, FMEA, Value Stream Mapping, Manufacturing, Six Sigma, DMAIC, Engineering, Manufacturing..., Quality Control, Cross-functional Team..., Team Leadership, ISO, SAP, Supervisory Skills, MRP, Equipment Qualification, Process Validation, Creative Problem Solving, Initiator, Multitasker
Education
Polytechnic University of Puerto Rico 2011 — 2015
M.S. in Engineering Management, Manufacturing Engineering, 3.85
Unilatina International College 2006 — 2007
Diploma Program, Small Business Management
Universidad Industrial de Santander 2001 — 2005
Bachelor of Science (B.S.), Industrial Engineering, 4.0
John Simonelli's HeartWare Inc Experience March 2015 - Present
Job Senior QA Electrical Engineer at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2015 - Present
HeartWare Inc October 2013 - March 2015
A123 Systems May 2012 - October 2013
International Rectifier April 2011 - May 2012
International Rectifier July 2008 - April 2011
Skills
Electronics, Electrical Engineering, FMEA, Manufacturing, Failure Analysis, Product Engineering, Data Analysis, Cross-functional Team..., Semiconductors, Analog, Engineering Management, PCB design, Program Management, Process Improvement, SPC, Engineering, Design for Manufacturing, Testing, Manufacturing..., Six Sigma, Root Cause Analysis, Lean Manufacturing
Education
University of Hartford 2006 — 2008
Masters, Electrical Engineering
University of Hartford 2002 — 2006
Bachelors, Audio Engineering Technology
HeartWare Inc March 2015 - Present
HeartWare Inc October 2013 - March 2015
A123 Systems May 2012 - October 2013
International Rectifier April 2011 - May 2012
International Rectifier July 2008 - April 2011
Skills
Electronics, Electrical Engineering, FMEA, Manufacturing, Failure Analysis, Product Engineering, Data Analysis, Cross-functional Team..., Semiconductors, Analog, Engineering Management, PCB design, Program Management, Process Improvement, SPC, Engineering, Design for Manufacturing, Testing, Manufacturing..., Six Sigma, Root Cause Analysis, Lean Manufacturing
Education
University of Hartford 2006 — 2008
Masters, Electrical Engineering
University of Hartford 2002 — 2006
Bachelors, Audio Engineering Technology
April Noyce's HeartWare Inc Experience September 2014 - Present
Job Complaint Backlog, Retrospective Review and Remediation at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc September 2014 - Present
Fresenius Medical Care December 2013 - August 2014
Synthes/Depuy August 2013 - December 2013
Terumo Cardiovascular Systems March 2012 - March 2013
Terumo Cardiovascular August 2010 - January 2012
Terumo Cardiovascular Systems August 2010 - July 2011
Medtronic May 2010 - August 2010
GE Healthcare April 2007 - May 2010
AT&T/Lucent Technologies January 1993 - January 2001
Skills
CAPA, Quality System, FDA, Quality Assurance, Medical Devices, Quality Control, Quality Auditing, Root Cause Analysis, ISO 13485, Auditing, Process Improvement, Manufacturing, Research, Training, Testing, Software Documentation, Regulatory Affairs, Internal Communications, Technical Writing, Six Sigma, Database Admin, Continuous Improvement, Writing, Project Management, Team Leadership, Database Management, Document Control, Document Management
Education
University of Phoenix 2004 — 2007
M.A, Adult Education
Southern Nazarene University 1995 — 1996
B.S, Management of Organizational Leadership
HeartWare Inc September 2014 - Present
Fresenius Medical Care December 2013 - August 2014
Synthes/Depuy August 2013 - December 2013
Terumo Cardiovascular Systems March 2012 - March 2013
Terumo Cardiovascular August 2010 - January 2012
Terumo Cardiovascular Systems August 2010 - July 2011
Medtronic May 2010 - August 2010
GE Healthcare April 2007 - May 2010
AT&T/Lucent Technologies January 1993 - January 2001
Skills
CAPA, Quality System, FDA, Quality Assurance, Medical Devices, Quality Control, Quality Auditing, Root Cause Analysis, ISO 13485, Auditing, Process Improvement, Manufacturing, Research, Training, Testing, Software Documentation, Regulatory Affairs, Internal Communications, Technical Writing, Six Sigma, Database Admin, Continuous Improvement, Writing, Project Management, Team Leadership, Database Management, Document Control, Document Management
Education
University of Phoenix 2004 — 2007
M.A, Adult Education
Southern Nazarene University 1995 — 1996
B.S, Management of Organizational Leadership
Alexander Goncharov's HeartWare Inc Experience March 2015 - Present
Job Electrical Engineer II at HeartWare Inc.
Industry Medical Devices
Experience
HeartWare Inc March 2015 - Present
HeartWare Inc April 2013 - March 2015
Abbott Point of Care October 2010 - November 2012
J.P. Laboratories November 2008 - October 2010
Skills
Biomedical Engineering, Medical Devices, Product Development, FDA, Design Control, Matlab, Root Cause Analysis, V&V, Programming Concepts, Circuit Testing, Circuit Analysis, Circuit Design, Circuit Theory, CAD, Finite Element Analysis, MEMS, COMSOL, Pro Engineer, Solid Edge, Technical Writing, Engineering Statistics, Cost Saving Projects, Engineering Analysis, Mathematical Modeling, Partial Differential..., Ordinary Differential..., Microcontrollers, Microprocessors, Analog Circuits, Digital Circuit Design, Prosthetics, OrCAD Capture CIS, Signal Processing, Mixed Signal, R&D, GMP, Simulations, Labview
Education
New Jersey Institute of Technology 2009 — 2010
Master of Science (M.S.), Biomedical/Medical Engineering
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2009
Bachelor of Science (B.S.), Biomedical/Medical Engineering
HeartWare Inc March 2015 - Present
HeartWare Inc April 2013 - March 2015
Abbott Point of Care October 2010 - November 2012
J.P. Laboratories November 2008 - October 2010
Skills
Biomedical Engineering, Medical Devices, Product Development, FDA, Design Control, Matlab, Root Cause Analysis, V&V, Programming Concepts, Circuit Testing, Circuit Analysis, Circuit Design, Circuit Theory, CAD, Finite Element Analysis, MEMS, COMSOL, Pro Engineer, Solid Edge, Technical Writing, Engineering Statistics, Cost Saving Projects, Engineering Analysis, Mathematical Modeling, Partial Differential..., Ordinary Differential..., Microcontrollers, Microprocessors, Analog Circuits, Digital Circuit Design, Prosthetics, OrCAD Capture CIS, Signal Processing, Mixed Signal, R&D, GMP, Simulations, Labview
Education
New Jersey Institute of Technology 2009 — 2010
Master of Science (M.S.), Biomedical/Medical Engineering
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2009
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Consuelo Velez's HeartWare Inc Experience March 2014 - Present
Job QA Specialist at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc March 2014 - Present
HeartWare Inc March 2014 - Present
Cordis Corporation,a Johnson and Johnson company 2005 - February 2014
Southern Diagnostic Associates 1997 - 2004
Skills
Training, FDA, GMP, Medical Devices, Quality Assurance, Quality System, CAPA, Regulatory Affairs, V&V, 21 CFR Part 11, Sop, Regulatory Submissions, Auditing, Quality Auditing, ISO 13485, Validation, SOP
Education
Miami Dade College 1978 — 1980
Miami Springs Sr. 1974 — 1977
High School diploma
HeartWare Inc March 2014 - Present
HeartWare Inc March 2014 - Present
Cordis Corporation,a Johnson and Johnson company 2005 - February 2014
Southern Diagnostic Associates 1997 - 2004
Skills
Training, FDA, GMP, Medical Devices, Quality Assurance, Quality System, CAPA, Regulatory Affairs, V&V, 21 CFR Part 11, Sop, Regulatory Submissions, Auditing, Quality Auditing, ISO 13485, Validation, SOP
Education
Miami Dade College 1978 — 1980
Miami Springs Sr. 1974 — 1977
High School diploma
Ricardo Gonzalez Amaya's HeartWare Inc Experience July 2014 - Present
Job Senior Manager, Quality Assurance at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc July 2014 - Present
HeartWare Inc May 2011 - June 2014
Boston Scientific June 2006 - May 2011
Telcordia Technologies February 2000 - June 2006
Banco Popular de Puerto Rico January 1999 - July 1999
Skills
Quality Assurance, Testing, FDA, Validation, Quality System, SDLC, V&V, CAPA, 21 CFR Part 11, Software Development, Medical Devices, ISO 13485, GMP, ISO, Design for Manufacturing, Six Sigma, Manufacturing, DMAIC, Quality Management, FMEA, Minitab, Cross-functional Team..., Quality Control, ISO 14971, Sop, Software Documentation, Design Control, Change Control
Education
University of New Orleans 2008 — 2009
Master of Business Administration (MBA)
Universidad de Puerto Rico 1994 — 1999
Bachelor of Science
Colegio San Jose 1988 — 1994
High School Diploma
HeartWare Inc July 2014 - Present
HeartWare Inc May 2011 - June 2014
Boston Scientific June 2006 - May 2011
Telcordia Technologies February 2000 - June 2006
Banco Popular de Puerto Rico January 1999 - July 1999
Skills
Quality Assurance, Testing, FDA, Validation, Quality System, SDLC, V&V, CAPA, 21 CFR Part 11, Software Development, Medical Devices, ISO 13485, GMP, ISO, Design for Manufacturing, Six Sigma, Manufacturing, DMAIC, Quality Management, FMEA, Minitab, Cross-functional Team..., Quality Control, ISO 14971, Sop, Software Documentation, Design Control, Change Control
Education
University of New Orleans 2008 — 2009
Master of Business Administration (MBA)
Universidad de Puerto Rico 1994 — 1999
Bachelor of Science
Colegio San Jose 1988 — 1994
High School Diploma
Dennis Derr's HeartWare Inc Experience April 2013 - Present
Job Sr. Mechanical Designer at HeartWare Inc.
Industry Medical Devices
Experience
HeartWare Inc. April 2013 - Present
Miami, FL December 2011 - April 2013
Boston Scientific May 1995 - December 2011
Boston Scientific May 1995 - December 2011
Boston Scientific May 1995 - December 2011
Skills
Control Systems Design, Process Improvement, Mechanical Engineering, Solidworks, Construction, Lean Manufacturing, Manufacturing, Troubleshooting, Validation, Medical Devices, Testing, Root Cause Analysis, Software Documentation, FDA, Continuous Improvement, Automation, Design Control, Engineering, V&V, GMP, Manufacturing..., SolidWorks
Education
Additional Training
Associate of Science (A.S.), Electronics Engineering Technology
Miami Dade College
A.S. in Electronics Engineering Technology, Electronics
HeartWare Inc. April 2013 - Present
Miami, FL December 2011 - April 2013
Boston Scientific May 1995 - December 2011
Boston Scientific May 1995 - December 2011
Boston Scientific May 1995 - December 2011
Skills
Control Systems Design, Process Improvement, Mechanical Engineering, Solidworks, Construction, Lean Manufacturing, Manufacturing, Troubleshooting, Validation, Medical Devices, Testing, Root Cause Analysis, Software Documentation, FDA, Continuous Improvement, Automation, Design Control, Engineering, V&V, GMP, Manufacturing..., SolidWorks
Education
Additional Training
Associate of Science (A.S.), Electronics Engineering Technology
Miami Dade College
A.S. in Electronics Engineering Technology, Electronics
Noah Vawter's HeartWare Inc Experience November 2012 - Present
Job Lead Firmware Developer at HeartWare Inc.
Industry Consumer Electronics
Experience
HeartWare Inc. November 2012 - Present
AMD February 2012 - October 2012
LevelUp January 2012 - January 2012
CAPS Productions October 2011 - October 2011
Microwave Radio Communcations September 2011 - October 2011
Eski, Inc. March 2011 - April 2011
DURRIDGE Company, Inc. October 2010 - October 2010
MIT Media Lab September 2004 - August 2010
MonkeyLectric May 2008 - August 2008
Echo Nest May 2007 - July 2007
Skills
Firmware, Debugging, Device Drivers, Embedded Systems, FPGA, Digital Signal..., Hardware Architecture, Verilog, ARM, Processors, USB, C, ASIC, Microcontrollers, Algorithms, Linux, PCB design, C++, Signal Processing, Python, PCB Design
Education
MIT 2004 — 2010
MS, PhD
Massachusetts Institute of Technology 2004 — 2010
Doctor of Philosophy (PhD)
NFA
WPI
Bachelor of Science (BS)
HeartWare Inc. November 2012 - Present
AMD February 2012 - October 2012
LevelUp January 2012 - January 2012
CAPS Productions October 2011 - October 2011
Microwave Radio Communcations September 2011 - October 2011
Eski, Inc. March 2011 - April 2011
DURRIDGE Company, Inc. October 2010 - October 2010
MIT Media Lab September 2004 - August 2010
MonkeyLectric May 2008 - August 2008
Echo Nest May 2007 - July 2007
Skills
Firmware, Debugging, Device Drivers, Embedded Systems, FPGA, Digital Signal..., Hardware Architecture, Verilog, ARM, Processors, USB, C, ASIC, Microcontrollers, Algorithms, Linux, PCB design, C++, Signal Processing, Python, PCB Design
Education
MIT 2004 — 2010
MS, PhD
Massachusetts Institute of Technology 2004 — 2010
Doctor of Philosophy (PhD)
NFA
WPI
Bachelor of Science (BS)
Daniel Pogue's HeartWare Inc Experience July 2012 - Present
Job Engineering consultant, Freelance Animator and Videographer.
Industry Marketing and Advertising
Experience
HeartWare Inc July 2012 - Present
Intertech Engineering Associates, Inc. July 2012 - July 2013
MK3 Creative May 2011 - September 2011
Organogenesis Inc. June 2008 - May 2011
Skills
Photoshop, Subversion, Editing, Microsoft Office, HTML, Programming, Motion Graphics, Project Management, Maya
Education
Massachusetts College of Art 2010 — 2012
Bachelor of Fine Arts (BFA), Animation, Interactive Technology, Video Graphics and Special Effects, graduated with departmental honors in animation.
HeartWare Inc July 2012 - Present
Intertech Engineering Associates, Inc. July 2012 - July 2013
MK3 Creative May 2011 - September 2011
Organogenesis Inc. June 2008 - May 2011
Skills
Photoshop, Subversion, Editing, Microsoft Office, HTML, Programming, Motion Graphics, Project Management, Maya
Education
Massachusetts College of Art 2010 — 2012
Bachelor of Fine Arts (BFA), Animation, Interactive Technology, Video Graphics and Special Effects, graduated with departmental honors in animation.
Joseph Wascura, PMP, SSBB's HeartWare Inc Experience May 2012 - Present
Job Senior Process Development Engineer
Industry Medical Devices
Experience
HeartWare Inc May 2012 - Present
Boston Scientific May 2010 - May 2012
Boston Scientific January 2008 - March 2010
Boston Scientific 2005 - 2008
Boston Scientific 2002 - 2005
Boston Scientific 2001 - 2002
Ethicon Endo-Surgery 1999 - 2000
Skills
Six Sigma, Lean Manufacturing, Manufacturing..., Gage R&R, Process Development, Process Capability, PMP, PMI, Control Charts, Process Validation, FDA, CAPA, Biomedical Engineering, Medical Devices, Measurement System..., Quality Systems, Minitab, SIPOC, Value Stream, Pareto Analysis, Design Control
Education
University of Florida 2007 — 2009
Master of Business Administration (M.B.A.)
University of Illinois at Urbana-Champaign 1996 — 2001
Bachelor's degree, Mechanical Engineering
Miami Sunset High
HeartWare Inc May 2012 - Present
Boston Scientific May 2010 - May 2012
Boston Scientific January 2008 - March 2010
Boston Scientific 2005 - 2008
Boston Scientific 2002 - 2005
Boston Scientific 2001 - 2002
Ethicon Endo-Surgery 1999 - 2000
Skills
Six Sigma, Lean Manufacturing, Manufacturing..., Gage R&R, Process Development, Process Capability, PMP, PMI, Control Charts, Process Validation, FDA, CAPA, Biomedical Engineering, Medical Devices, Measurement System..., Quality Systems, Minitab, SIPOC, Value Stream, Pareto Analysis, Design Control
Education
University of Florida 2007 — 2009
Master of Business Administration (M.B.A.)
University of Illinois at Urbana-Champaign 1996 — 2001
Bachelor's degree, Mechanical Engineering
Miami Sunset High
Tristan Raniga's HeartWare Inc Experience August 2013 - May 2014
Job Associate Engineer at VytronUS
Industry Medical Devices
Experience
VytronUS January 2015 - Present
HeartWare Inc August 2013 - May 2014
HeartWare Inc January 2013 - January 2014
University of Miami, Department of Biomedical Engineering September 2009 - May 2013
Kaiser Permanente June 2007 - June 2009
Keck Graduate Institute June 2008 - August 2008
Skills
Microsoft Office, SolidWorks, Biomedical Engineering, Data Analysis, Solidworks, Product Development, Public Speaking, Medical Devices, Research, Testing
Education
University of Miami 2009 — 2014
Master's Degree, Biomedical Engineering
VytronUS January 2015 - Present
HeartWare Inc August 2013 - May 2014
HeartWare Inc January 2013 - January 2014
University of Miami, Department of Biomedical Engineering September 2009 - May 2013
Kaiser Permanente June 2007 - June 2009
Keck Graduate Institute June 2008 - August 2008
Skills
Microsoft Office, SolidWorks, Biomedical Engineering, Data Analysis, Solidworks, Product Development, Public Speaking, Medical Devices, Research, Testing
Education
University of Miami 2009 — 2014
Master's Degree, Biomedical Engineering
Cory Guenot's HeartWare Inc Experience May 2012 - August 2012
Job Mechanical Engineer
Industry Mechanical or Industrial Engineering
Experience
HeartWare Inc May 2012 - August 2012
POST ONE April 2011 - January 2012
JUNIOR ACHIEVEMENT August 2008 - May 2009
TILE INTERNATIONAL April 2008 - January 2009
Education
University of Central Florida 2008 — 2012
Bachelor of Science, Mechanical Engineering; Mechanical Systems
Chaminade-Madonna College Preparatory Academy 2004 — 2008
High School Diploma
HeartWare Inc May 2012 - August 2012
POST ONE April 2011 - January 2012
JUNIOR ACHIEVEMENT August 2008 - May 2009
TILE INTERNATIONAL April 2008 - January 2009
Education
University of Central Florida 2008 — 2012
Bachelor of Science, Mechanical Engineering; Mechanical Systems
Chaminade-Madonna College Preparatory Academy 2004 — 2008
High School Diploma
Altie Eljaiek's HeartWare Inc Experience September 2012 - Present
Job Change Management Analyst at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc September 2012 - Present
Education
Miami Dade College
Associate of Science (AS), Mechanical Engineering
HeartWare Inc September 2012 - Present
Education
Miami Dade College
Associate of Science (AS), Mechanical Engineering
Lawrence Mulholland's HeartWare Inc Experience January 2009 - Present
Job Sr. Manufacturing Engineer, Tool Design and Qualfication Supervisor at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2009 - Present
Caterpillar Inc. February 1999 - March 2007
Education
Iowa State University 1984 — 1988
Bachelor's Degree, INdustrial/Manufacturing Engineering, 4.50/5.0
HeartWare Inc January 2009 - Present
Caterpillar Inc. February 1999 - March 2007
Education
Iowa State University 1984 — 1988
Bachelor's Degree, INdustrial/Manufacturing Engineering, 4.50/5.0
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY