Bolton Medical
Industry: Company
DescriptionFounded: 1998 Parent organization: Terumo Aortic Limited
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Bolton Medical Employees
Employee
Years
Job
Industry
Ryan McElveen Ryan McElveen's Bolton Medical Experience January 2013 - Present
Job Endovascular Sales
Industry Hospital & Health Care
Experience
Bolton Medical January 2013 - Present
WL Gore & Associates April 2004 - December 2012
W.L. Gore & Associates April 2004 - November 2012
Boston Scientific, Microvasive August 2000 - March 2004
E. & J. Gallo Winery March 1999 - July 2000
E. & J. Gallo Winery February 1997 - March 1999
E. & J. Gallo Winery August 1995 - January 1998
Skills
Vascular Surgery, Operating Room, Stents, Interventional..., Capital Equipment, Interventional Radiology, Vascular, Cath Lab, Product Launch, Medical Imaging, Endovascular, Operating Room Sales, Sales Management, Project Management, Urology, Disposables, Surgeons, Surgical Instruments, Medical Devices, Market Development
Education
Florida State University
Bachelor of Arts
Florida State University 1990 — 1994
Bolton Medical January 2013 - Present
WL Gore & Associates April 2004 - December 2012
W.L. Gore & Associates April 2004 - November 2012
Boston Scientific, Microvasive August 2000 - March 2004
E. & J. Gallo Winery March 1999 - July 2000
E. & J. Gallo Winery February 1997 - March 1999
E. & J. Gallo Winery August 1995 - January 1998
Skills
Vascular Surgery, Operating Room, Stents, Interventional..., Capital Equipment, Interventional Radiology, Vascular, Cath Lab, Product Launch, Medical Imaging, Endovascular, Operating Room Sales, Sales Management, Project Management, Urology, Disposables, Surgeons, Surgical Instruments, Medical Devices, Market Development
Education
Florida State University
Bachelor of Arts
Florida State University 1990 — 1994
Matthew Empey's Bolton Medical Experience September 2012 - July 2014
Job Senior Endovascular Sales Representative at Medtronic
Industry Medical Devices
Experience
Medtronic January 2015 - Present
Surefire Medical, Inc. July 2014 - January 2015
Bolton Medical September 2012 - July 2014
Covidien April 2012 - October 2012
St. Jude Medical November 2008 - January 2012
BD October 2005 - November 2008
Skills
Interventional Radiology, Interventional..., Vascular Surgery, Endovascular Surgery, Fluent in Spanish, TEVAR, EVAR, Class III Medical..., Vascular, Cath Lab, Interventional, Cardiac Surgery, Surgical Instruments, Surgeons, Selling, Product Launch, Medicine, Medical Devices, Market Development, Endovascular, Clinical Research, Cardiology, Capital Equipment
Education
Brigham Young University 2000 — 2002
B.S., Economics
Brigham Young University - Idaho 1999 — 2000
A.S., Business Management
Medtronic January 2015 - Present
Surefire Medical, Inc. July 2014 - January 2015
Bolton Medical September 2012 - July 2014
Covidien April 2012 - October 2012
St. Jude Medical November 2008 - January 2012
BD October 2005 - November 2008
Skills
Interventional Radiology, Interventional..., Vascular Surgery, Endovascular Surgery, Fluent in Spanish, TEVAR, EVAR, Class III Medical..., Vascular, Cath Lab, Interventional, Cardiac Surgery, Surgical Instruments, Surgeons, Selling, Product Launch, Medicine, Medical Devices, Market Development, Endovascular, Clinical Research, Cardiology, Capital Equipment
Education
Brigham Young University 2000 — 2002
B.S., Economics
Brigham Young University - Idaho 1999 — 2000
A.S., Business Management
Oscar Rospigliosi Oscar Rospigliosi's Bolton Medical Experience 2004 - 2013
Job Partner at Newport Board Group
Industry Management Consulting
Experience
Newport Board Group April 2014 - Present
Bolton Medical 2004 - 2013
Comesa Poland April 2000 - December 2004
Instrumentation Laboratory February 1998 - April 2000
PwC July 1990 - September 1997
Skills
Medical Devices, Business Strategy, Cross-functional Team..., Product Development, New Business Development, Strategic Planning, Product Management, Start-ups, Market Development, Product Launch, Change Management, Negotiation, Business Planning, Product Marketing, Marketing Management, Private Equity, Deal Flow, Strategy, Leadership
Education
University of Miami - School of Business 2008 — 2009
2009
Massachusetts Institute of Technology - Sloan School of Management 2010 — 2010
Harvard Business School 2005 — 2005
CECO 1996 — 1997
Newport Board Group April 2014 - Present
Bolton Medical 2004 - 2013
Comesa Poland April 2000 - December 2004
Instrumentation Laboratory February 1998 - April 2000
PwC July 1990 - September 1997
Skills
Medical Devices, Business Strategy, Cross-functional Team..., Product Development, New Business Development, Strategic Planning, Product Management, Start-ups, Market Development, Product Launch, Change Management, Negotiation, Business Planning, Product Marketing, Marketing Management, Private Equity, Deal Flow, Strategy, Leadership
Education
University of Miami - School of Business 2008 — 2009
2009
Massachusetts Institute of Technology - Sloan School of Management 2010 — 2010
Harvard Business School 2005 — 2005
CECO 1996 — 1997
Adela Smith's Bolton Medical Experience November 2008 - February 2015
Job Marketing Specialist
Industry Medical Devices
Experience
Axess Oncology, Inc. August 2015 - Present
Bolton Medical November 2008 - February 2015
BOLTON MEDICAL, INC July 2008 - February 2015
Bolton Medical July 2008 - February 2015
2006-2008 SLIDELL MEMORIAL HOSPITAL July 2006 - January 2008
Slidell Memorial Hospital March 2006 - January 2008
2004-2005 CENTRAL FLORIDA April 2004 - July 2005
2003-2004 CENTRAL FLORIDA January 2003 - April 2004
Oracle March 2000 - March 2003
Oracle 2000 - 2003
Skills
Computer Programming, Business Administration, Product Marketing, Web Design, Interactive Media, Microsoft Office, Event Management, Trade Shows, Management, Project Management, Event Planning, Marketing, Team Building, Budgets, Negotiation, Business Development, Public Relations, Product Development, Product Launch
Education
Art Institute of Pittsburgh 2014 — 2015
Marketing/Advertising
Exhibitor FastTrak 2013 — 2013
Certificate of Achievement, TradeShow Marketer
Art Institute of Pittsburgh 2008 — 2012
Associate Degree, Web Design & Interactive Media
Seward Park High School, Manhattan, NY 1981 — 1982
High School Diploma, Business Administration
New Horizons Learning Center
Certificate, Web Design and Interactive Media
Seward Park High School, New York City (High School 1982 — 1983
High School Diploma, Business Administration
University of Puerto Rico 1989 — 1989
Certificate, D.O.S. (Disk Operating System)
Axess Oncology, Inc. August 2015 - Present
Bolton Medical November 2008 - February 2015
BOLTON MEDICAL, INC July 2008 - February 2015
Bolton Medical July 2008 - February 2015
2006-2008 SLIDELL MEMORIAL HOSPITAL July 2006 - January 2008
Slidell Memorial Hospital March 2006 - January 2008
2004-2005 CENTRAL FLORIDA April 2004 - July 2005
2003-2004 CENTRAL FLORIDA January 2003 - April 2004
Oracle March 2000 - March 2003
Oracle 2000 - 2003
Skills
Computer Programming, Business Administration, Product Marketing, Web Design, Interactive Media, Microsoft Office, Event Management, Trade Shows, Management, Project Management, Event Planning, Marketing, Team Building, Budgets, Negotiation, Business Development, Public Relations, Product Development, Product Launch
Education
Art Institute of Pittsburgh 2014 — 2015
Marketing/Advertising
Exhibitor FastTrak 2013 — 2013
Certificate of Achievement, TradeShow Marketer
Art Institute of Pittsburgh 2008 — 2012
Associate Degree, Web Design & Interactive Media
Seward Park High School, Manhattan, NY 1981 — 1982
High School Diploma, Business Administration
New Horizons Learning Center
Certificate, Web Design and Interactive Media
Seward Park High School, New York City (High School 1982 — 1983
High School Diploma, Business Administration
University of Puerto Rico 1989 — 1989
Certificate, D.O.S. (Disk Operating System)
Kyle Fater's Bolton Medical Experience December 2008 - November 2012
Job Direct Flow Medical TAVR TDS
Industry Medical Devices
Experience
Direct Flow Medical®, Inc. January 2015 - Present
TriVascular November 2012 - January 2015
Bolton Medical December 2008 - November 2012
Cook Medical Aortic Intervention SBU April 2008 - December 2008
Cook Medical Aortic Intervention SBU April 2007 - April 2008
Sun Health Research Institute September 2006 - March 2007
Skills
Clinical Research, Medical Devices, Vascular Surgery, Vascular, Interventional Radiology, Healthcare, Market Development, Cardiac Surgery, Cross-functional Team..., Strategic Planning, Start-ups, New Business Development, Clinical, Consultative Selling, Negotiation, Cold Calling, Clinical Training, Radiology, Clinical Trials, Surgeons, Interventional..., Medical Imaging, Cardiology, Physicians, Hospitals, Catheters, Surgery
Education
Wayne State University 2002 — 2006
BS, Pathologists' Assistant
Purdue University 2001 — 2002
Direct Flow Medical®, Inc. January 2015 - Present
TriVascular November 2012 - January 2015
Bolton Medical December 2008 - November 2012
Cook Medical Aortic Intervention SBU April 2008 - December 2008
Cook Medical Aortic Intervention SBU April 2007 - April 2008
Sun Health Research Institute September 2006 - March 2007
Skills
Clinical Research, Medical Devices, Vascular Surgery, Vascular, Interventional Radiology, Healthcare, Market Development, Cardiac Surgery, Cross-functional Team..., Strategic Planning, Start-ups, New Business Development, Clinical, Consultative Selling, Negotiation, Cold Calling, Clinical Training, Radiology, Clinical Trials, Surgeons, Interventional..., Medical Imaging, Cardiology, Physicians, Hospitals, Catheters, Surgery
Education
Wayne State University 2002 — 2006
BS, Pathologists' Assistant
Purdue University 2001 — 2002
Patricia Collins, RN, CCRP Patricia Collins, RN, CCRP's Bolton Medical Experience October 2013 - Present
Job Clinical Research Associate at Bolton Medical
Industry Research
Experience
Collins Consulting Services August 2009 - Present
Bolton Medical October 2013 - Present
SonaCare Medical, LLC (formerly US HIFU) January 2011 - October 2013
PushMed LLC January 2009 - August 2013
Omnicare Clinical Research January 2009 - July 2009
United States Air Force December 1988 - January 2009
Omnicare Clinical Research January 2007 - 2009
Omnicare Clinical Research January 2006 - 2007
Omnicare Clinical Research October 2004 - 2006
Skills
Prostate Cancer, Cardiovascular Devices, Interventional..., Cardiovascular Disease, Rheumatology, Diabetes, Pediatric Endocrinology, Endocrinology, Leadership, Project Management, Medical Ultrasound, Neuromuscular, Pulmonary Diseases, Medical Devices, Protocol, EDC, Clinical Trials, Clinical Monitoring, Clinical Research, CRO
Education
Maria College 1983 — 1985
AAS, Nursing
Maria College of Albany
Associate of Arts and Sciences (AAS), Registered Nursing/Registered Nurse
Collins Consulting Services August 2009 - Present
Bolton Medical October 2013 - Present
SonaCare Medical, LLC (formerly US HIFU) January 2011 - October 2013
PushMed LLC January 2009 - August 2013
Omnicare Clinical Research January 2009 - July 2009
United States Air Force December 1988 - January 2009
Omnicare Clinical Research January 2007 - 2009
Omnicare Clinical Research January 2006 - 2007
Omnicare Clinical Research October 2004 - 2006
Skills
Prostate Cancer, Cardiovascular Devices, Interventional..., Cardiovascular Disease, Rheumatology, Diabetes, Pediatric Endocrinology, Endocrinology, Leadership, Project Management, Medical Ultrasound, Neuromuscular, Pulmonary Diseases, Medical Devices, Protocol, EDC, Clinical Trials, Clinical Monitoring, Clinical Research, CRO
Education
Maria College 1983 — 1985
AAS, Nursing
Maria College of Albany
Associate of Arts and Sciences (AAS), Registered Nursing/Registered Nurse
Santiago Figueroa Santiago Figueroa's Bolton Medical Experience July 2014 - Present
Job Associate R&D Quality Assurance Engineer at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical July 2014 - Present
Florida International University April 2013 - June 2014
Skills
Solidworks, SPC, AutoCAD, Minitab, Data Analysis, Biomedical Engineering, Microsoft Office, PowerPoint, Microsoft Excel, Spanish, Research, Teamwork, Microsoft Word, Leadership, Public Speaking, Critical Thinking, Social Media, Event Planning, Customer Service
Education
Florida International University 2009 — 2014
Bachelor of Science (BS), Biomedical/Medical Engineering
Bolton Medical July 2014 - Present
Florida International University April 2013 - June 2014
Skills
Solidworks, SPC, AutoCAD, Minitab, Data Analysis, Biomedical Engineering, Microsoft Office, PowerPoint, Microsoft Excel, Spanish, Research, Teamwork, Microsoft Word, Leadership, Public Speaking, Critical Thinking, Social Media, Event Planning, Customer Service
Education
Florida International University 2009 — 2014
Bachelor of Science (BS), Biomedical/Medical Engineering
Bryand Acosta Bryand Acosta's Bolton Medical Experience September 2012 - October 2012
Job Software Engineer at Aderant
Industry Mechanical or Industrial Engineering
Experience
Aderant June 2013 - Present
Florida International University October 2012 - May 2013
Shell Eco Marathon Competition August 2012 - May 2013
Bolton Medical September 2012 - October 2012
UCI Engineering August 2008 - December 2008
Skills
Software Engineering, Typescript, C#, jQuery, JavaScript, WPF, SQL, MVVM, HTML, .NET, KnockoutJS, Kendo, CSS, LESS, RequireJS, LINQ, Programming, TFS, Microsoft SQL Server, ASP.NET MVC, ASP.NET, Unit Testing, Visual Studio, Scrum, Solidworks, ANSYS, Matlab, AutoCAD, CAD, Engineering, Manufacturing, Finite Element Analysis, Testing, Aerospace, Mechanical Engineering, Software Development, XAML, SolidWorks, LabVIEW, C++
Education
Florida International University 2007 — 2012
Bachelor of Science (BS), Mechanical Engineering
Colegio la Piedad 2003 — 2007
High School Diploma
Aderant June 2013 - Present
Florida International University October 2012 - May 2013
Shell Eco Marathon Competition August 2012 - May 2013
Bolton Medical September 2012 - October 2012
UCI Engineering August 2008 - December 2008
Skills
Software Engineering, Typescript, C#, jQuery, JavaScript, WPF, SQL, MVVM, HTML, .NET, KnockoutJS, Kendo, CSS, LESS, RequireJS, LINQ, Programming, TFS, Microsoft SQL Server, ASP.NET MVC, ASP.NET, Unit Testing, Visual Studio, Scrum, Solidworks, ANSYS, Matlab, AutoCAD, CAD, Engineering, Manufacturing, Finite Element Analysis, Testing, Aerospace, Mechanical Engineering, Software Development, XAML, SolidWorks, LabVIEW, C++
Education
Florida International University 2007 — 2012
Bachelor of Science (BS), Mechanical Engineering
Colegio la Piedad 2003 — 2007
High School Diploma
Gianluca Luongo Gianluca Luongo's Bolton Medical Experience December 2005 - March 2013
Job Senior Clinical Specialist
Industry Medical Devices
Experience
Bolton Medical Inc. April 2013 - Present
Bolton Medical Inc. April 2013 - Present
Bolton Medical December 2005 - March 2013
Azienda ospedaliera San Gerardo Nuovo November 2002 - September 2005
Istituto ortopedico Galeazzi November 2000 - October 2002
Skills
Stents, Vascular, Medical Devices, Biomedical Engineering, Vascular Surgery, Interventional Radiology, Interventional..., Anesthesiology, Nursing, ALS, Radiologia..., Vascolare, Ortopedia, Strumenti medicali, Cardiologia...
Education
Università degli Studi di Milano 1995 — 1998
Scienze infermieristiche, Nursing sciences
Università degli Studi di Milano 1995 — 1998
Scienze Infermieristiche
Bolton Medical Inc. April 2013 - Present
Bolton Medical Inc. April 2013 - Present
Bolton Medical December 2005 - March 2013
Azienda ospedaliera San Gerardo Nuovo November 2002 - September 2005
Istituto ortopedico Galeazzi November 2000 - October 2002
Skills
Stents, Vascular, Medical Devices, Biomedical Engineering, Vascular Surgery, Interventional Radiology, Interventional..., Anesthesiology, Nursing, ALS, Radiologia..., Vascolare, Ortopedia, Strumenti medicali, Cardiologia...
Education
Università degli Studi di Milano 1995 — 1998
Scienze infermieristiche, Nursing sciences
Università degli Studi di Milano 1995 — 1998
Scienze Infermieristiche
Heather Harries's Bolton Medical Experience April 2015 - Present
Job Vice President of Quality Assurance at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical April 2015 - Present
Heather Harries Medical Device Consulting, Inc. November 2009 - Present
Johnson & Johnson November 2012 - April 2015
Cordis July 2010 - November 2012
HeartWare Inc January 2008 - September 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY May 2005 - December 2007
Cordis March 2003 - May 2005
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY December 2000 - March 2003
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1998 - December 2000
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1997 - July 1998
Skills
Healthcare, R&D, Medical Devices, Quality Assurance, Program Management, Product Development, Quality Engineering, Quality Auditing, ISO standards, Risk Management, Change Management, Change Control, FDA, Engineering, Problem Solving, Testing, Technical Writing, Design Control, ISO 13485, Cross-functional Team..., Quality Management, Product Launch, Project Planning, Biotechnology, Quality System, FMEA, Manufacturing, Design of Experiments, Root Cause Analysis, ISO, Validation, Quality Control, CAPA, V&V, Team Leadership, Regulatory Affairs, Process Engineering, GMP, Sop, Software Documentation, Minitab, DMAIC, ISO 14971, Process Simulation, 21 CFR Part 11, Biomedical Engineering, SPC, Commercialization, Technology Transfer, Leadership
Education
Florida International University 1999 — 2001
M.S., Engineering Management
Dartmouth College 1995 — 1997
M.S., Biomaterials Engineering
Duke University 1991 — 1995
BS, Biomedical and Mechanical Engineering and Materials Science
Ellenville Central 1979 — 1991
High School Degree, General
Bolton Medical April 2015 - Present
Heather Harries Medical Device Consulting, Inc. November 2009 - Present
Johnson & Johnson November 2012 - April 2015
Cordis July 2010 - November 2012
HeartWare Inc January 2008 - September 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY May 2005 - December 2007
Cordis March 2003 - May 2005
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY December 2000 - March 2003
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1998 - December 2000
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1997 - July 1998
Skills
Healthcare, R&D, Medical Devices, Quality Assurance, Program Management, Product Development, Quality Engineering, Quality Auditing, ISO standards, Risk Management, Change Management, Change Control, FDA, Engineering, Problem Solving, Testing, Technical Writing, Design Control, ISO 13485, Cross-functional Team..., Quality Management, Product Launch, Project Planning, Biotechnology, Quality System, FMEA, Manufacturing, Design of Experiments, Root Cause Analysis, ISO, Validation, Quality Control, CAPA, V&V, Team Leadership, Regulatory Affairs, Process Engineering, GMP, Sop, Software Documentation, Minitab, DMAIC, ISO 14971, Process Simulation, 21 CFR Part 11, Biomedical Engineering, SPC, Commercialization, Technology Transfer, Leadership
Education
Florida International University 1999 — 2001
M.S., Engineering Management
Dartmouth College 1995 — 1997
M.S., Biomaterials Engineering
Duke University 1991 — 1995
BS, Biomedical and Mechanical Engineering and Materials Science
Ellenville Central 1979 — 1991
High School Degree, General
Patricia Rivera Patricia Rivera's Bolton Medical Experience February 2014 - Present
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
Ron Steinman Ron Steinman's Bolton Medical Experience November 2012 - March 2013
Job Territory Sales Manager at TriVascular, Inc
Industry Medical Devices
Experience
TriVascular, Inc April 2013 - Present
Bolton Medical November 2012 - March 2013
Terumo December 2005 - November 2012
Medtronic April 2004 - March 2005
Guidant Cardiac Surgery April 2003 - April 2004
Advanced Medical Optics/Allergan Dermatology January 1994 - April 2003
Skills
Medical Devices, Cardiac Surgery, Surgery, Sales Operations, Capital Equipment, Sales Management, Operating Room, Surgeons, New Business Development, Product Development, Disposables
Education
State University of New York at Albany 1985 — 1989
TriVascular, Inc April 2013 - Present
Bolton Medical November 2012 - March 2013
Terumo December 2005 - November 2012
Medtronic April 2004 - March 2005
Guidant Cardiac Surgery April 2003 - April 2004
Advanced Medical Optics/Allergan Dermatology January 1994 - April 2003
Skills
Medical Devices, Cardiac Surgery, Surgery, Sales Operations, Capital Equipment, Sales Management, Operating Room, Surgeons, New Business Development, Product Development, Disposables
Education
State University of New York at Albany 1985 — 1989
Mayhela Villarroel,CQE,CQA Mayhela Villarroel,CQE,CQA's Bolton Medical Experience January 2007 - July 2013
Job Quality Systems Specialist/ ISO Representative
Industry Logistics and Supply Chain
Experience
Gexpro Services/Rexel USA September 2014 - Present
NeilMed Pharmaceuticals July 2013 - August 2014
Bolton Medical January 2007 - July 2013
Skills
Medical Devices, ISO 13485, CAPA, FDA, Quality System, Validation, Root Cause Analysis, GMP, ISO 14971, Quality Auditing, ISO, Quality Control, Quality Assurance, Supplier Quality, SPC, Quality Management
Education
Universidad de Carabobo 1998 — 2004
Industrial Engineer, Industrial Engineering
Universidad de Carabobo 1998 — 2004
Ingeniero, Industrial
Gexpro Services/Rexel USA September 2014 - Present
NeilMed Pharmaceuticals July 2013 - August 2014
Bolton Medical January 2007 - July 2013
Skills
Medical Devices, ISO 13485, CAPA, FDA, Quality System, Validation, Root Cause Analysis, GMP, ISO 14971, Quality Auditing, ISO, Quality Control, Quality Assurance, Supplier Quality, SPC, Quality Management
Education
Universidad de Carabobo 1998 — 2004
Industrial Engineer, Industrial Engineering
Universidad de Carabobo 1998 — 2004
Ingeniero, Industrial
Claudia Pelaez Claudia Pelaez's Bolton Medical Experience January 2013 - Present
Job Assistant Controller at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical January 2013 - Present
Allegheny Medical Systems January 2012 - January 2013
Samsung Electronics Latinoamerica Miami March 2011 - October 2011
Samsung Electronics December 2008 - March 2011
RG 512 July 2006 - December 2008
Moyal Accounting Services January 2004 - June 2006
USA Peru Assoc. Service Corp. January 2003 - December 2003
Bayer June 2002 - November 2002
Ediciones Santillana November 2001 - May 2002
PricewaterhouseCoopers January 1996 - November 2001
Skills
QuickBooks, General Ledger, Financial Reporting, Accounting, Internal Controls, US GAAP, Auditing, Variance Analysis, Payroll, Journal Entries, Financial Statements, Tax Preparation, External Audit, Corporate Tax, Invoicing, Income Tax, Analysis, Bank Reconciliation, Sarbanes-Oxley Act, Internal Audit, Cost Accounting, Sales Tax, Accruals, Financial Accounting, Fixed Assets, Account Reconciliation, IFRS
Education
Becker Profesional Education 2010 — 2011
CPA Test Review
Universidad Inca Garcilaso de la Vega 1992 — 1997
CPA, Accounting
Bolton Medical January 2013 - Present
Allegheny Medical Systems January 2012 - January 2013
Samsung Electronics Latinoamerica Miami March 2011 - October 2011
Samsung Electronics December 2008 - March 2011
RG 512 July 2006 - December 2008
Moyal Accounting Services January 2004 - June 2006
USA Peru Assoc. Service Corp. January 2003 - December 2003
Bayer June 2002 - November 2002
Ediciones Santillana November 2001 - May 2002
PricewaterhouseCoopers January 1996 - November 2001
Skills
QuickBooks, General Ledger, Financial Reporting, Accounting, Internal Controls, US GAAP, Auditing, Variance Analysis, Payroll, Journal Entries, Financial Statements, Tax Preparation, External Audit, Corporate Tax, Invoicing, Income Tax, Analysis, Bank Reconciliation, Sarbanes-Oxley Act, Internal Audit, Cost Accounting, Sales Tax, Accruals, Financial Accounting, Fixed Assets, Account Reconciliation, IFRS
Education
Becker Profesional Education 2010 — 2011
CPA Test Review
Universidad Inca Garcilaso de la Vega 1992 — 1997
CPA, Accounting
Tony Manguno Tony Manguno's Bolton Medical Experience January 2012 - Present
Job Senior R&D Engineer at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical January 2012 - Present
Bolton Medical, Inc. April 2007 - February 2012
Cordis June 2003 - March 2007
Cordis Corporation a Johnson and Johnson Company June 2003 - March 2007
GlaxoSmithKline January 2003 - June 2003
Skills
Design Control, Medical Devices, Solidworks, CAPA, Design of Experiments, FMEA, Stents, Product Development, R&D, Delivery Systems, Engineering Management, Biomedical Engineering, CAD, Medical Device Product..., Engineering, Validation, FDA, Cross-functional Team..., ISO 13485, Catheters, Commercialization, V&V, Root Cause Analysis, Injection Molding, Quality System, ISO 14971, Drug Delivery
Education
Florida International University 2005 — 2006
Master of Science, Engineering Management with Concentration in Biomedical Engineering
Florida International University 1999 — 2002
BS, Mechanical/Biomedical Engineering
Bolton Medical January 2012 - Present
Bolton Medical, Inc. April 2007 - February 2012
Cordis June 2003 - March 2007
Cordis Corporation a Johnson and Johnson Company June 2003 - March 2007
GlaxoSmithKline January 2003 - June 2003
Skills
Design Control, Medical Devices, Solidworks, CAPA, Design of Experiments, FMEA, Stents, Product Development, R&D, Delivery Systems, Engineering Management, Biomedical Engineering, CAD, Medical Device Product..., Engineering, Validation, FDA, Cross-functional Team..., ISO 13485, Catheters, Commercialization, V&V, Root Cause Analysis, Injection Molding, Quality System, ISO 14971, Drug Delivery
Education
Florida International University 2005 — 2006
Master of Science, Engineering Management with Concentration in Biomedical Engineering
Florida International University 1999 — 2002
BS, Mechanical/Biomedical Engineering
Darin Beach Darin Beach's Bolton Medical Experience October 2012 - October 2014
Job Territory ManagerTriVascular
Industry Medical Devices
Experience
TriVascular, Inc October 2014 - Present
Bolton Medical October 2012 - October 2014
Spectranetics August 2008 - October 2012
Cook Medical April 2006 - August 2008
Skills
Disposables, Cath Lab, Operating Room, Interventional..., Vascular, Capital Equipment, Interventional Radiology, Surgeons, Vascular Surgery, Medical Devices, Surgical Instruments, Stents, Cardiology, Cardiac Surgery, Market Development, Urology, Orthopedic, Catheters, Surgery, Clinical Research, Critical Care, Hospitals, OB/GYN, Sales Operations
Education
Bowling Green State University 1987 — 1990
Bachelor of Arts (B.A.), Communications and Marketing
Heidelberg College 1985 — 1987
Business Administration and Management, General
Marion General Hospital School of Radiologic Technology
AS in Radiologic Sciences, Radiologic Technology/Science - Radiographer, 3.7
TriVascular, Inc October 2014 - Present
Bolton Medical October 2012 - October 2014
Spectranetics August 2008 - October 2012
Cook Medical April 2006 - August 2008
Skills
Disposables, Cath Lab, Operating Room, Interventional..., Vascular, Capital Equipment, Interventional Radiology, Surgeons, Vascular Surgery, Medical Devices, Surgical Instruments, Stents, Cardiology, Cardiac Surgery, Market Development, Urology, Orthopedic, Catheters, Surgery, Clinical Research, Critical Care, Hospitals, OB/GYN, Sales Operations
Education
Bowling Green State University 1987 — 1990
Bachelor of Arts (B.A.), Communications and Marketing
Heidelberg College 1985 — 1987
Business Administration and Management, General
Marion General Hospital School of Radiologic Technology
AS in Radiologic Sciences, Radiologic Technology/Science - Radiographer, 3.7
Lizzi Martinez Lizzi Martinez's Bolton Medical Experience November 2013 - Present
Job Clinical Research Trials
Industry Research
Experience
Bolton Medical November 2013 - Present
Palm Springs Research Institute September 2011 - August 2012
Central Medical Group, P.A. 2006 - 2010
Skills
Science, Research, Clinical Trials, Clinical Research, Microsoft Office, Training, CTMS, GCP, Biotechnology, EDC, Protocol, Regulatory Submissions
Education
Keiser University-Ft Lauderdale
Bolton Medical November 2013 - Present
Palm Springs Research Institute September 2011 - August 2012
Central Medical Group, P.A. 2006 - 2010
Skills
Science, Research, Clinical Trials, Clinical Research, Microsoft Office, Training, CTMS, GCP, Biotechnology, EDC, Protocol, Regulatory Submissions
Education
Keiser University-Ft Lauderdale
Brian Carolan Brian Carolan's Bolton Medical Experience November 2014 - Present
Job Endovsascular Consultant
Industry Medical Devices
Angela Henao Angela Henao's Bolton Medical Experience April 2014 - Present
Job Quality Assurance Engineer/Supervisor at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical April 2014 - Present
Bolton Medical January 2013 - April 2014
Bolton Medical June 2011 - December 2012
Florida International University January 2010 - June 2011
Skills
Solidworks, Microsoft Office, CAPA, ISO 13485, GMP, Microsoft Excel, Microsoft Word, PowerPoint, Matlab, AutoCAD, Data Analysis, Cell Culture, Statistics, Microscopy, English, Spanish, SolidWorks
Education
Penn State University 2014 — 2016
Master of Science (MS), Engineering/Industrial Management
Florida International University 2006 — 2011
Bachelor of Science (BS), Biomedical/Medical Engineering
Saint Brendan High School 2002 — 2006
High School
Bolton Medical April 2014 - Present
Bolton Medical January 2013 - April 2014
Bolton Medical June 2011 - December 2012
Florida International University January 2010 - June 2011
Skills
Solidworks, Microsoft Office, CAPA, ISO 13485, GMP, Microsoft Excel, Microsoft Word, PowerPoint, Matlab, AutoCAD, Data Analysis, Cell Culture, Statistics, Microscopy, English, Spanish, SolidWorks
Education
Penn State University 2014 — 2016
Master of Science (MS), Engineering/Industrial Management
Florida International University 2006 — 2011
Bachelor of Science (BS), Biomedical/Medical Engineering
Saint Brendan High School 2002 — 2006
High School
Michael Cropper, CQE Michael Cropper, CQE's Bolton Medical Experience January 2012 - Present
Job Senior Quality Assurance Engineer / New Product Introduction at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical January 2012 - Present
Bolton Medical February 2003 - January 2012
Medtronic January 1996 - November 2002
World Medical Manufacturing Corp January 1991 - January 1996
Skills
Design Control, Medical Devices, Validation, Quality Systems, ISO 13485, Product Development, Quality Engineering, FMEA, Quality Assurance, Testing, Documentation, R&D, Statistics, Root Cause Analysis, Injection Molding, Quality Control, CAPA, FDA, Quality System, ISO 14971
Education
Florida Atlantic University 1990 — 1996
Bolton Medical January 2012 - Present
Bolton Medical February 2003 - January 2012
Medtronic January 1996 - November 2002
World Medical Manufacturing Corp January 1991 - January 1996
Skills
Design Control, Medical Devices, Validation, Quality Systems, ISO 13485, Product Development, Quality Engineering, FMEA, Quality Assurance, Testing, Documentation, R&D, Statistics, Root Cause Analysis, Injection Molding, Quality Control, CAPA, FDA, Quality System, ISO 14971
Education
Florida Atlantic University 1990 — 1996
Alianny Gonzalez's Bolton Medical Experience March 2007 - July 2007
Job Credit and Logistics Manager at Fagor Commercial
Industry Food Production
Experience
Fagor Commercial January 2012 - Present
A & A Meats, Corp. June 2007 - January 2012
Bolton Medical March 2007 - July 2007
Skills
Management, FDA, Medical Devices, Quality System, Purchasing, SAP, Software Documentation, Validation, Procurement, Product Development, R&D, Quality Assurance
Education
Florida International University - College of Business Administration 2003 — 2007
Bachelor's, Management
Fagor Commercial January 2012 - Present
A & A Meats, Corp. June 2007 - January 2012
Bolton Medical March 2007 - July 2007
Skills
Management, FDA, Medical Devices, Quality System, Purchasing, SAP, Software Documentation, Validation, Procurement, Product Development, R&D, Quality Assurance
Education
Florida International University - College of Business Administration 2003 — 2007
Bachelor's, Management
Daniel Loureiro Daniel Loureiro's Bolton Medical Experience May 2015 - Present
Job Contract R&D Engineer at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical May 2015 - Present
Bolton Medical May 2014 - May 2015
University of Miami August 2010 - May 2015
Brendon Flynn SAT Prep August 2010 - May 2015
University of Miami August 2013 - May 2014
University of Miami January 2012 - August 2013
Neuroprosthetics Research Group June 2012 - August 2012
Phonak July 2009 - July 2009
Phonak June 2009 - June 2009
Skills
Matlab, Biomedical Engineering, Solidworks, Spanish, Microsoft Office, Pspice, Medical Devices, Microsoft Excel, C++, ISO 13485, PowerPoint, R&D, COMSOL, CAPA, Brazilian Portuguese, Research, ISO 10993, ISO 14971, 21 CFR 820, FMEA, Fault Tree Analysis, Design, PMAs, 510(k), ANOVA, TeraRecon, Microsoft Word, Minitab, Engineering, Validation, Testing, Data Analysis, Medical Imaging, FDA, Public Speaking, Product Development, AutoCAD, Biomaterials, Mechanical Engineering, Programming, Statistics, Stents, Vascular
Education
University of Miami 2010 — 2015
Master of Science (M.S.), Biomedical/Medical Engineering, 4.0 GPA
University of Miami 2010 — 2015
Bachelor of Science (B.S.), Biomedical/Medical Engineering, 3.75 Major GPA
Bolton Medical May 2015 - Present
Bolton Medical May 2014 - May 2015
University of Miami August 2010 - May 2015
Brendon Flynn SAT Prep August 2010 - May 2015
University of Miami August 2013 - May 2014
University of Miami January 2012 - August 2013
Neuroprosthetics Research Group June 2012 - August 2012
Phonak July 2009 - July 2009
Phonak June 2009 - June 2009
Skills
Matlab, Biomedical Engineering, Solidworks, Spanish, Microsoft Office, Pspice, Medical Devices, Microsoft Excel, C++, ISO 13485, PowerPoint, R&D, COMSOL, CAPA, Brazilian Portuguese, Research, ISO 10993, ISO 14971, 21 CFR 820, FMEA, Fault Tree Analysis, Design, PMAs, 510(k), ANOVA, TeraRecon, Microsoft Word, Minitab, Engineering, Validation, Testing, Data Analysis, Medical Imaging, FDA, Public Speaking, Product Development, AutoCAD, Biomaterials, Mechanical Engineering, Programming, Statistics, Stents, Vascular
Education
University of Miami 2010 — 2015
Master of Science (M.S.), Biomedical/Medical Engineering, 4.0 GPA
University of Miami 2010 — 2015
Bachelor of Science (B.S.), Biomedical/Medical Engineering, 3.75 Major GPA
Martin Kareff's Bolton Medical Experience February 2015 - Present
Job Quality Assurance Engineer Supervisor
Industry Medical Devices
Experience
Bolton Medical February 2015 - Present
Bolton Medical August 2013 - Present
CellAntenna, Inc September 2011 - July 2013
Boston Scientific April 2010 - September 2011
Boston Scientific February 2007 - April 2010
Skills
Iso 9000, ISO 13485, ISO 14001, CAPA, SCAR, ISO9001 Auditor, Packaging Engineering, Validation, Six Sigma, Medical Devices, Root Cause Analysis, FMEA, Supplier Quality..., Project Management, NetSuite, SAP, Design Control, V&V, FDA, DMAIC, Green Belt, 21 CFR
Education
Nova Southeastern University 2009 — 2011
MBA, Business
University of Central Florida 2002 — 2006
B.S. Engineering Technology, Engineering
Bolton Medical February 2015 - Present
Bolton Medical August 2013 - Present
CellAntenna, Inc September 2011 - July 2013
Boston Scientific April 2010 - September 2011
Boston Scientific February 2007 - April 2010
Skills
Iso 9000, ISO 13485, ISO 14001, CAPA, SCAR, ISO9001 Auditor, Packaging Engineering, Validation, Six Sigma, Medical Devices, Root Cause Analysis, FMEA, Supplier Quality..., Project Management, NetSuite, SAP, Design Control, V&V, FDA, DMAIC, Green Belt, 21 CFR
Education
Nova Southeastern University 2009 — 2011
MBA, Business
University of Central Florida 2002 — 2006
B.S. Engineering Technology, Engineering
Michelle Barroso's Bolton Medical Experience November 2010 - Present
Job Regulatory Affairs Specialist at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical November 2010 - Present
Bolton Medical October 2008 - November 2010
Kos Pharmaceuticals March 2006 - August 2007
Medtronic February 2000 - October 2002
Skills
Excel, Word, Spanish, SAP, English, Lotus Notes, Adobe Acrobat, Documentation, Quality Systems, ISO 13485, FDA, Software Documentation, Quality System, Microsoft Word, Quality Assurance, Medical Devices, CAPA, Validation, GMP, Management, Regulatory Affairs, Pharmaceutical Industry, V&V, SOP, Medical Device Directive, Design Control, CE marking, Microsoft Excel
Education
Florida International University
Bachelors, Business Management
Seminar
Bolton Medical November 2010 - Present
Bolton Medical October 2008 - November 2010
Kos Pharmaceuticals March 2006 - August 2007
Medtronic February 2000 - October 2002
Skills
Excel, Word, Spanish, SAP, English, Lotus Notes, Adobe Acrobat, Documentation, Quality Systems, ISO 13485, FDA, Software Documentation, Quality System, Microsoft Word, Quality Assurance, Medical Devices, CAPA, Validation, GMP, Management, Regulatory Affairs, Pharmaceutical Industry, V&V, SOP, Medical Device Directive, Design Control, CE marking, Microsoft Excel
Education
Florida International University
Bachelors, Business Management
Seminar
Megan Eckerman Megan Eckerman's Bolton Medical Experience May 2014 - Present
Job Vice President of Global Marketing
Industry Medical Devices
Experience
Bolton Medical May 2014 - Present
Intuitive Surgical March 2013 - February 2014
Medtronic Vascular January 2010 - March 2013
Medtronic Vascular January 2007 - December 2009
Medtronic Vascular December 2005 - January 2007
Medtronic Vascular June 2003 - December 2005
United States Air Force January 2001 - May 2003
Skills
Market Development, Global Marketing, Cross-functional Team..., Marketing Strategy, Competitive Analysis, Product Development, Market Research, Market Analysis, Healthcare, Strategic Planning, Marketing, Strategy, Selling, Sales Operations, Sales, Surgeons, Medical Terminology, Medical Devices, Marketing Communications
Education
University of Colorado Colorado Springs 2000 — 2002
MBA, Marketing
Indiana University Bloomington 1994 — 1998
Kinesiology
Bolton Medical May 2014 - Present
Intuitive Surgical March 2013 - February 2014
Medtronic Vascular January 2010 - March 2013
Medtronic Vascular January 2007 - December 2009
Medtronic Vascular December 2005 - January 2007
Medtronic Vascular June 2003 - December 2005
United States Air Force January 2001 - May 2003
Skills
Market Development, Global Marketing, Cross-functional Team..., Marketing Strategy, Competitive Analysis, Product Development, Market Research, Market Analysis, Healthcare, Strategic Planning, Marketing, Strategy, Selling, Sales Operations, Sales, Surgeons, Medical Terminology, Medical Devices, Marketing Communications
Education
University of Colorado Colorado Springs 2000 — 2002
MBA, Marketing
Indiana University Bloomington 1994 — 1998
Kinesiology
Meredith Walker RT(R), CT, VI's Bolton Medical Experience November 2012 - September 2013
Job RT(R), CT, VI
Industry Hospital & Health Care
Experience
Terumo November 2014 - Present
Novant Health June 2014 - November 2014
Bolton Medical November 2012 - September 2013
University of Virginia Health System May 2010 - November 2012
Carilion Clinic October 2003 - May 2010
Skills
Inventory Management, Team Leadership, EPIC(Computer based..., Interventional Radiology, Radiology, MRI, Medical Devices, Radiography, PACS, Radiologic Technology, Vascular, Computed Tomography, Medical Imaging, Fluoroscopy, Angiography, Ultrasound, ARRT, Hospitals, Healthcare, RIS, Peripheral Vascular, Mammography, Cardiovascular Imaging, X-ray, Operating Room, Interventional..., Cat Scan, C-arm, Cath Lab, Computed Radiography, Clinical Specialists, Pain Management
Education
Virginia Polytechnic Institute and State University 2005 — 2006
Chemistry
New River Community College 2004 — 2006
N/A, Liberal Arts/Nursing
Broome Community College 2000 — 2002
AAS, Radiology Technology
Terumo November 2014 - Present
Novant Health June 2014 - November 2014
Bolton Medical November 2012 - September 2013
University of Virginia Health System May 2010 - November 2012
Carilion Clinic October 2003 - May 2010
Skills
Inventory Management, Team Leadership, EPIC(Computer based..., Interventional Radiology, Radiology, MRI, Medical Devices, Radiography, PACS, Radiologic Technology, Vascular, Computed Tomography, Medical Imaging, Fluoroscopy, Angiography, Ultrasound, ARRT, Hospitals, Healthcare, RIS, Peripheral Vascular, Mammography, Cardiovascular Imaging, X-ray, Operating Room, Interventional..., Cat Scan, C-arm, Cath Lab, Computed Radiography, Clinical Specialists, Pain Management
Education
Virginia Polytechnic Institute and State University 2005 — 2006
Chemistry
New River Community College 2004 — 2006
N/A, Liberal Arts/Nursing
Broome Community College 2000 — 2002
AAS, Radiology Technology
Ioan Bonneville Ioan Bonneville's Bolton Medical Experience August 2009 - October 2009
Job Biotechnology Professional
Industry Biotechnology
Experience
Bolton Medical August 2009 - October 2009
DeVry University 2006 - 2009
BizAvenue January 2001 - January 2002
CDI College January 2000 - January 2002
Maisons Trudeau January 1999 - October 1999
Bonneville Industries May 1997 - January 1999
Education
DeVry University 2006 — 2009
BMET, Biomedical, engineering, Maths, Calculus, Electronics, Physics, Microprocessors
DeVry University 2006 — 2009
Bachelor of Science, Biomedical Engineer
LaSalle College
Bolton Medical August 2009 - October 2009
DeVry University 2006 - 2009
BizAvenue January 2001 - January 2002
CDI College January 2000 - January 2002
Maisons Trudeau January 1999 - October 1999
Bonneville Industries May 1997 - January 1999
Education
DeVry University 2006 — 2009
BMET, Biomedical, engineering, Maths, Calculus, Electronics, Physics, Microprocessors
DeVry University 2006 — 2009
Bachelor of Science, Biomedical Engineer
LaSalle College
Subhan Khan Subhan Khan's Bolton Medical Experience 2003 - 2004
Job VP, Research and Development at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical December 2012 - Present
Maquet Cardiovascular April 2010 - October 2012
Terumo Heart, Inc July 2004 - April 2010
Bolton Medical 2003 - 2004
Novoste Corporation 1998 - 2003
Boston Scientific 1995 - 1998
CR Bard 1993 - 1995
Boston Scientific 1993 - 1993
Skills
Medical Devices, ISO 13485, Design Control, FDA, R&D, Biomedical Engineering, Quality System, Commercialization, Validation, Product Development, Start-ups, Product Launch, Strategic Planning, Strategic Negotiations, Overseas Experience, Intellectual Property, New Business Development, Business Planning, Manufacturing, Strategic Roadmaps, KOL development, Biomaterials, Cross-functional Team..., ISO, Strategy, Continuous Improvement, Process Simulation, V&V, Injection Molding, GMP, Medical Device R&D, Biotechnology, Capital Equipment, CAPA, Surgical Instruments, Market Development, Design for Manufacturing, Product Design
Education
University of Massachusetts at Lowell 1990 — 1993
Bachelor of Science (B.Sc.), Mechanical Engineering
University of Massachusetts at Lowell
Master of Science (M.Sc.), Plastics Engineering
St. Jude Medical December 2012 - Present
Maquet Cardiovascular April 2010 - October 2012
Terumo Heart, Inc July 2004 - April 2010
Bolton Medical 2003 - 2004
Novoste Corporation 1998 - 2003
Boston Scientific 1995 - 1998
CR Bard 1993 - 1995
Boston Scientific 1993 - 1993
Skills
Medical Devices, ISO 13485, Design Control, FDA, R&D, Biomedical Engineering, Quality System, Commercialization, Validation, Product Development, Start-ups, Product Launch, Strategic Planning, Strategic Negotiations, Overseas Experience, Intellectual Property, New Business Development, Business Planning, Manufacturing, Strategic Roadmaps, KOL development, Biomaterials, Cross-functional Team..., ISO, Strategy, Continuous Improvement, Process Simulation, V&V, Injection Molding, GMP, Medical Device R&D, Biotechnology, Capital Equipment, CAPA, Surgical Instruments, Market Development, Design for Manufacturing, Product Design
Education
University of Massachusetts at Lowell 1990 — 1993
Bachelor of Science (B.Sc.), Mechanical Engineering
University of Massachusetts at Lowell
Master of Science (M.Sc.), Plastics Engineering
Jeff Foust's Bolton Medical Experience August 2014 - Present
Job Bolton Medical Endovascular Consultant
Industry Medical Devices
Experience
Bolton Medical August 2014 - Present
Bayer Healthcare Interventional August 2011 - August 2014
Angioslide January 2011 - August 2011
ARIES Scientific April 2010 - January 2011
Endologix Inc February 2008 - April 2010
Atrium Medical October 2004 - February 2008
Cook Medical February 2002 - October 2004
ARIES Scientific 1988 - 2001
Skills
Contract Negotiation, Forecasting, Management, Marketing Strategy, Negotiation, Product Marketing, Sales Effectiveness, Sales Force Development, Selling, Training, Sales
Education
University of Oklahoma 1984 — 1988
B.A.S., Business and Communications
Bolton Medical August 2014 - Present
Bayer Healthcare Interventional August 2011 - August 2014
Angioslide January 2011 - August 2011
ARIES Scientific April 2010 - January 2011
Endologix Inc February 2008 - April 2010
Atrium Medical October 2004 - February 2008
Cook Medical February 2002 - October 2004
ARIES Scientific 1988 - 2001
Skills
Contract Negotiation, Forecasting, Management, Marketing Strategy, Negotiation, Product Marketing, Sales Effectiveness, Sales Force Development, Selling, Training, Sales
Education
University of Oklahoma 1984 — 1988
B.A.S., Business and Communications
Jesica McLane's Bolton Medical Experience September 2014 - Present
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
Nico Bahar's Bolton Medical Experience July 2011 - Present
Job Research and Development Engineer at Bolton Medical
Industry Biotechnology
Experience
Bolton Medical July 2011 - Present
Cordis Corporation November 2005 - October 2010
Cordis 2005 - 2007
Skills
Design Control, Process Validation, CAPA, Medical Devices, Design of Experiments, FDA, Validation, GMP, Process Excellence, Quality Systems, Solidworks, R&D, Six Sigma, Kaizen, Process Development, ISO 13485, Biomedical Engineering, ISO 14971, Process Simulation, Product Development, Quality System, Root Cause Analysis, V&V
Education
University of Miami 2003 — 2005
Bolton Medical July 2011 - Present
Cordis Corporation November 2005 - October 2010
Cordis 2005 - 2007
Skills
Design Control, Process Validation, CAPA, Medical Devices, Design of Experiments, FDA, Validation, GMP, Process Excellence, Quality Systems, Solidworks, R&D, Six Sigma, Kaizen, Process Development, ISO 13485, Biomedical Engineering, ISO 14971, Process Simulation, Product Development, Quality System, Root Cause Analysis, V&V
Education
University of Miami 2003 — 2005
Tim Lostetter's Bolton Medical Experience March 2008 - Present
Job R&D Engineer
Industry Medical Devices
Experience
Bolton Medical March 2008 - Present
Bolton Medical June 2003 - March 2008
Novoste May 2002 - June 2003
Medtronic May 1999 - May 2002
World Medical MFG Corp. January 1997 - May 1999
Skills
Medical Devices, R&D, Validation, Product Development, Design Control, Manufacturing, FDA, Solidworks, Testing, Design of Experiments, Quality System, Biomedical Engineering, FMEA, ISO, Process Simulation, ISO 14971, Machining, Manufacturing..., Lean Manufacturing, GMP, Quality Assurance, Product Launch, Engineering, Injection Molding, 3D Printing, Capital Equipment, Catheters, Commercialization, Cross-functional Team..., DMAIC, Design for Manufacturing, Market Development, Medical Imaging, Minitab, Plastics, Quality Control, Product Design, Root Cause Analysis
Education
ERUDIO College 2006 — 2008
A.S., Business
Broward Community College 1998 — 1999
Certification, Aviation Maintenance Technologies (AMT)
Bolton Medical March 2008 - Present
Bolton Medical June 2003 - March 2008
Novoste May 2002 - June 2003
Medtronic May 1999 - May 2002
World Medical MFG Corp. January 1997 - May 1999
Skills
Medical Devices, R&D, Validation, Product Development, Design Control, Manufacturing, FDA, Solidworks, Testing, Design of Experiments, Quality System, Biomedical Engineering, FMEA, ISO, Process Simulation, ISO 14971, Machining, Manufacturing..., Lean Manufacturing, GMP, Quality Assurance, Product Launch, Engineering, Injection Molding, 3D Printing, Capital Equipment, Catheters, Commercialization, Cross-functional Team..., DMAIC, Design for Manufacturing, Market Development, Medical Imaging, Minitab, Plastics, Quality Control, Product Design, Root Cause Analysis
Education
ERUDIO College 2006 — 2008
A.S., Business
Broward Community College 1998 — 1999
Certification, Aviation Maintenance Technologies (AMT)
Mark Carzo's Bolton Medical Experience January 2006 - June 2007
Job Eastern US Sales Director at OnX Life Technologies
Industry Medical Devices
Experience
On-X LIfe Technologies, Inc. 2008 - Present
On-X Life Technologies August 2008 - June 2009
Bolton Medical January 2006 - June 2007
CryoLife, Inc. January 2003 - November 2006
CryoLife, Inc. December 1999 - December 2002
CryoLife, Inc. November 1998 - December 1999
CroLife, Inc. November 1996 - November 1998
Education
Merrimack College 1978 — 1982
On-X LIfe Technologies, Inc. 2008 - Present
On-X Life Technologies August 2008 - June 2009
Bolton Medical January 2006 - June 2007
CryoLife, Inc. January 2003 - November 2006
CryoLife, Inc. December 1999 - December 2002
CryoLife, Inc. November 1998 - December 1999
CroLife, Inc. November 1996 - November 1998
Education
Merrimack College 1978 — 1982
Tom Fernandez's Bolton Medical Experience April 2008 - June 2013
Job Operations Consultant at TNI Mfg
Industry Medical Devices
Experience
TNI Mfg November 2014 - Present
ORTHOSENSOR October 2013 - November 2014
Self-Employed June 2013 - October 2013
Bolton Medical April 2008 - June 2013
Bolton Medical September 2004 - April 2008
Cordis - A Johnson and Johnson Company September 2002 - September 2004
Medtronic March 2000 - September 2002
Boston Scientific September 1998 - March 2000
Skills
ISO 13485, FMEA, Design Control, GMP, CAPA, FDA, Quality System, Medical Devices, Lean Manufacturing, R&D, V&V, Validation, Testing, Process Improvement, Manufacturing, Management, Product Development, Cross-functional Team..., Engineering, Root Cause Analysis, Design of Experiments, Quality Assurance, Quality Control, ISO, Biomedical Engineering, Commercialization, ISO 14971, DMAIC, SPC, Minitab, Injection Molding, Quality Auditing, Six Sigma
Education
Florida International University 1996 — 1999
MBA, Management
Columbia University in the City of New York 1990 — 1993
B.S., Mechanical Engineering
TNI Mfg November 2014 - Present
ORTHOSENSOR October 2013 - November 2014
Self-Employed June 2013 - October 2013
Bolton Medical April 2008 - June 2013
Bolton Medical September 2004 - April 2008
Cordis - A Johnson and Johnson Company September 2002 - September 2004
Medtronic March 2000 - September 2002
Boston Scientific September 1998 - March 2000
Skills
ISO 13485, FMEA, Design Control, GMP, CAPA, FDA, Quality System, Medical Devices, Lean Manufacturing, R&D, V&V, Validation, Testing, Process Improvement, Manufacturing, Management, Product Development, Cross-functional Team..., Engineering, Root Cause Analysis, Design of Experiments, Quality Assurance, Quality Control, ISO, Biomedical Engineering, Commercialization, ISO 14971, DMAIC, SPC, Minitab, Injection Molding, Quality Auditing, Six Sigma
Education
Florida International University 1996 — 1999
MBA, Management
Columbia University in the City of New York 1990 — 1993
B.S., Mechanical Engineering
Joe Paparella, CQE's Bolton Medical Experience April 2006 - February 2011
Job Quality Manager at Gables Engineering
Industry Aviation & Aerospace
Experience
Gables Engineering April 2015 - Present
Beckman Coulter January 2014 - April 2015
Beckman Coulter February 2011 - December 2013
Bolton Medical April 2006 - February 2011
Independent Consultant November 2003 - April 2006
Medtronic Peripheral Vascular October 2000 - November 2003
Gamo USA / BSA Optics January 1997 - January 1998
Tasco Sales Incorporated January 1992 - January 1997
Skills
ISO 13485, Quality Systems, Supplier Quality, FDA, CAPA, Medical Devices, Quality Engineering, ISO, Quality Assurance, Quality Auditing, Quality System, Biomedical Engineering, V&V, Testing, Manufacturing, Lean Manufacturing, Design Control, DMAIC, Solidworks, Validation, Six Sigma, Quality Control, SolidWorks, GMP
Education
Florida International University 2011 — 2011
Master of Science, Engineering Management
DeVry University
Bachelor of Science, Biomedical Engineering Technology
Miami-Dade Community College
Associate in Arts
Gables Engineering April 2015 - Present
Beckman Coulter January 2014 - April 2015
Beckman Coulter February 2011 - December 2013
Bolton Medical April 2006 - February 2011
Independent Consultant November 2003 - April 2006
Medtronic Peripheral Vascular October 2000 - November 2003
Gamo USA / BSA Optics January 1997 - January 1998
Tasco Sales Incorporated January 1992 - January 1997
Skills
ISO 13485, Quality Systems, Supplier Quality, FDA, CAPA, Medical Devices, Quality Engineering, ISO, Quality Assurance, Quality Auditing, Quality System, Biomedical Engineering, V&V, Testing, Manufacturing, Lean Manufacturing, Design Control, DMAIC, Solidworks, Validation, Six Sigma, Quality Control, SolidWorks, GMP
Education
Florida International University 2011 — 2011
Master of Science, Engineering Management
DeVry University
Bachelor of Science, Biomedical Engineering Technology
Miami-Dade Community College
Associate in Arts
Neverson James's Bolton Medical Experience June 2008 - Present
Job Manufacturing Engineering Manager at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical June 2008 - Present
Bolton Medical Inc. September 2007 - June 2008
Bolton Medical January 2003 - September 2007
Medtronic AVE March 2001 - December 2002
Baxter Healthcare June 2000 - March 2001
Skills
Lean Six Sigma Black..., Manufacturing, ISO 13485, Design of Experiments, Design Control, FMEA, Quality System, Lean Manufacturing, CAPA, FDA, Root Cause Analysis, Medical Devices, V&V, Validation, ISO, Solidworks, Minitab, DMAIC, Six Sigma, Business Process..., Manufacturing...
Education
North Carolina Agricultural and Technical State University 1993 — 1998
BSIE, Industrial Engineering
North Carolina Agricultural and Technical State University
Bolton Medical June 2008 - Present
Bolton Medical Inc. September 2007 - June 2008
Bolton Medical January 2003 - September 2007
Medtronic AVE March 2001 - December 2002
Baxter Healthcare June 2000 - March 2001
Skills
Lean Six Sigma Black..., Manufacturing, ISO 13485, Design of Experiments, Design Control, FMEA, Quality System, Lean Manufacturing, CAPA, FDA, Root Cause Analysis, Medical Devices, V&V, Validation, ISO, Solidworks, Minitab, DMAIC, Six Sigma, Business Process..., Manufacturing...
Education
North Carolina Agricultural and Technical State University 1993 — 1998
BSIE, Industrial Engineering
North Carolina Agricultural and Technical State University
Al Buti's Bolton Medical Experience November 2013 - Present
Job Vice President of Sales Bolton Medical
Industry Medical Devices
Experience
Bolton Medical November 2013 - Present
IDEV® Technologies, Inc. - a wholly owned subsidiary of Abbott Vascular June 2012 - November 2013
Medtronic Vascular, Medtronic Inc. 2009 - 2012
Medtronic May 2007 - May 2009
Medtronic January 2005 - May 2007
C.R. BARD August 2000 - January 2005
CR Bard 2000 - 2005
CR Bard 2000 - 2004
Bard Peripheral January 2000 - January 2002
CR Bard January 1990 - January 2000
Skills
Vascular, Commercialization, Leadership, Strategic Planning, Surgery, Operating Room, Medical Devices, Strategy, Surgeons, Sales Operations, Hospitals, Vascular Surgery, Management, Capital Equipment, Interventional..., Healthcare, Sales, Recruiting, Cath Lab, Business Strategy, Global Marketing, Sales Management, Market Development, Coaching, Building Relationships, FDA, Budgets, Cardiology, Selling, Product Launch, Surgical Instruments, Cross-functional Team..., Disposables, Sales Effectiveness, CRM, Orthopedic, Interventional Radiology, Clinical Research, Neurosurgery, Medical Sales, Neurology, Pharmaceutical Sales, Cardiac Surgery, Urology, Spine, Sales Force Development, OB/GYN, ENT, Selling Skills, Capital Equipment Sales
Education
St. Mary's College 1978 — 1982
B.S, Business Administration
Saint Mary's University of Minnesota 1974 — 1978
Bachelor of Science (B.S.), Business/Marketing
Bolton Medical November 2013 - Present
IDEV® Technologies, Inc. - a wholly owned subsidiary of Abbott Vascular June 2012 - November 2013
Medtronic Vascular, Medtronic Inc. 2009 - 2012
Medtronic May 2007 - May 2009
Medtronic January 2005 - May 2007
C.R. BARD August 2000 - January 2005
CR Bard 2000 - 2005
CR Bard 2000 - 2004
Bard Peripheral January 2000 - January 2002
CR Bard January 1990 - January 2000
Skills
Vascular, Commercialization, Leadership, Strategic Planning, Surgery, Operating Room, Medical Devices, Strategy, Surgeons, Sales Operations, Hospitals, Vascular Surgery, Management, Capital Equipment, Interventional..., Healthcare, Sales, Recruiting, Cath Lab, Business Strategy, Global Marketing, Sales Management, Market Development, Coaching, Building Relationships, FDA, Budgets, Cardiology, Selling, Product Launch, Surgical Instruments, Cross-functional Team..., Disposables, Sales Effectiveness, CRM, Orthopedic, Interventional Radiology, Clinical Research, Neurosurgery, Medical Sales, Neurology, Pharmaceutical Sales, Cardiac Surgery, Urology, Spine, Sales Force Development, OB/GYN, ENT, Selling Skills, Capital Equipment Sales
Education
St. Mary's College 1978 — 1982
B.S, Business Administration
Saint Mary's University of Minnesota 1974 — 1978
Bachelor of Science (B.S.), Business/Marketing
Gigi Lawrence's Bolton Medical Experience October 2014 - Present
Job Gigi Lawrence
Industry Medical Devices
Experience
Bolton Medical October 2014 - Present
Atico International 2004 - 2014
Worldwide Flight Services January 2000 - June 2003
Skills
Sourcing, Employee Relations, Purchasing, International Trade, Merchandising, Global Sourcing, Negotiation, Logistics, Import, Inventory Management, Market Research, International Business, Supply Chain, Pricing, Product Management, Export, English, Consumer Products, Marketing Strategy, Vendor Management, Sales Management, Retail, Supply Chain Management, Forecasting, Product Marketing, Business Development, Outlook, Contract Negotiation, Management, Fashion, Strategic Planning, Product Development, Sales, Microsoft Word, Teamwork, New Business Development, Business Strategy, Apparel, PowerPoint, Microsoft Office, Store Management, Competitive Analysis, Microsoft Excel, Marketing, Budgets, Customer Service, Team Leadership
Education
Florida International University
Bolton Medical October 2014 - Present
Atico International 2004 - 2014
Worldwide Flight Services January 2000 - June 2003
Skills
Sourcing, Employee Relations, Purchasing, International Trade, Merchandising, Global Sourcing, Negotiation, Logistics, Import, Inventory Management, Market Research, International Business, Supply Chain, Pricing, Product Management, Export, English, Consumer Products, Marketing Strategy, Vendor Management, Sales Management, Retail, Supply Chain Management, Forecasting, Product Marketing, Business Development, Outlook, Contract Negotiation, Management, Fashion, Strategic Planning, Product Development, Sales, Microsoft Word, Teamwork, New Business Development, Business Strategy, Apparel, PowerPoint, Microsoft Office, Store Management, Competitive Analysis, Microsoft Excel, Marketing, Budgets, Customer Service, Team Leadership
Education
Florida International University
Edith Criollo's Bolton Medical Experience January 2002 - February 2007
Job Quality System Specialist at Stryker Orthopaedics
Industry Medical Devices
Experience
Stryker Mako October 2013 - Present
MAKO Surgical Corp. April 2012 - Present
MAKO August 2010 - August 2012
Bolton Medical January 2002 - February 2007
World Medical Inc. 1998 - 2001
Skills
Quality Systems, Word, Excel, Microsoft Office, Medical Devices, FDA, ISO 13485, Validation, Software Documentation, Quality Assurance, CAPA, GMP, Manufacturing, Quality Auditing, Quality System, Microsoft Word, Process Improvement, Microsoft Excel, Documentations, Root Cause Analysis, Product Development, Design Control, ISO, Quality Control, Orthopedic, Continuous Improvement, Cross-functional Team..., Team Building, Supplier Quality, V&V, Troubleshooting, Training, Design of Experiments, Quality Management, Medical Imaging, Biotechnology, 21 CFR Part 11, Testing, Minitab, R&D, Visio, Complaint Management
Education
Broward Community College 2007 — 2009
Associate of Arts and Sciences (AAS), HITT
ITT 2007 — 2009
AS, Health Information Technology
Stryker Mako October 2013 - Present
MAKO Surgical Corp. April 2012 - Present
MAKO August 2010 - August 2012
Bolton Medical January 2002 - February 2007
World Medical Inc. 1998 - 2001
Skills
Quality Systems, Word, Excel, Microsoft Office, Medical Devices, FDA, ISO 13485, Validation, Software Documentation, Quality Assurance, CAPA, GMP, Manufacturing, Quality Auditing, Quality System, Microsoft Word, Process Improvement, Microsoft Excel, Documentations, Root Cause Analysis, Product Development, Design Control, ISO, Quality Control, Orthopedic, Continuous Improvement, Cross-functional Team..., Team Building, Supplier Quality, V&V, Troubleshooting, Training, Design of Experiments, Quality Management, Medical Imaging, Biotechnology, 21 CFR Part 11, Testing, Minitab, R&D, Visio, Complaint Management
Education
Broward Community College 2007 — 2009
Associate of Arts and Sciences (AAS), HITT
ITT 2007 — 2009
AS, Health Information Technology
Marianne Staudenmeier's Bolton Medical Experience March 2002 - June 2003
Job Consultant
Industry Medical Devices
Experience
Davol, Inc. July 2003 - September 2012
Bolton Medical March 2002 - June 2003
Boston Scientific, Inc. (Meadox Medicals, Inc.) November 1990 - October 2000
Skills
Program Management, Cross-functional Team..., Project Management, Medical Devices, Process Improvement, Product Development, Strategic Planning, Change Management, Product Management, Lean Manufacturing, Design Control, Manufacturing, ISO 13485, Team Building, FDA, Product Launch, Continuous Improvement, Healthcare, Project Planning, FMEA, Quality System
Education
Rutgers, The State University of New Jersey - Rutgers Business School 1992 — 1997
Master of Business Administration (MBA)
Philadelphia University 1985 — 1989
Textile Engineering
Davol, Inc. July 2003 - September 2012
Bolton Medical March 2002 - June 2003
Boston Scientific, Inc. (Meadox Medicals, Inc.) November 1990 - October 2000
Skills
Program Management, Cross-functional Team..., Project Management, Medical Devices, Process Improvement, Product Development, Strategic Planning, Change Management, Product Management, Lean Manufacturing, Design Control, Manufacturing, ISO 13485, Team Building, FDA, Product Launch, Continuous Improvement, Healthcare, Project Planning, FMEA, Quality System
Education
Rutgers, The State University of New Jersey - Rutgers Business School 1992 — 1997
Master of Business Administration (MBA)
Philadelphia University 1985 — 1989
Textile Engineering
Martha A Moreno's Bolton Medical Experience August 2013 - Present
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
James Nong's Bolton Medical Experience May 2015 - Present
Job R&D Engineer at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical May 2015 - Present
Lifeline Sciences April 2014 - April 2015
Lancer Systems December 2013 - April 2014
Rex Medical April 2012 - September 2012
Orthovita/Stryker Orthobiologics April 2011 - September 2011
Good Shepherd Rehabilitation Hospital April 2010 - August 2010
Skills
ProEngineer, Solidworks, AutoCAD, Soldering, Machine Tools, Instron, MTS, MicroVu Vision System, Circuits, Microsoft Office, BCI 2000, Matlab, LabVIEW, PCR, Pro Engineer, Labview
Education
Drexel University 2008 — 2013
BS/MS Biomedical Engineering, Tissue Engineering
Bolton Medical May 2015 - Present
Lifeline Sciences April 2014 - April 2015
Lancer Systems December 2013 - April 2014
Rex Medical April 2012 - September 2012
Orthovita/Stryker Orthobiologics April 2011 - September 2011
Good Shepherd Rehabilitation Hospital April 2010 - August 2010
Skills
ProEngineer, Solidworks, AutoCAD, Soldering, Machine Tools, Instron, MTS, MicroVu Vision System, Circuits, Microsoft Office, BCI 2000, Matlab, LabVIEW, PCR, Pro Engineer, Labview
Education
Drexel University 2008 — 2013
BS/MS Biomedical Engineering, Tissue Engineering
Rene Medrano's Bolton Medical Experience January 2003 - May 2006
Job Validation Engineer at Promega
Industry Pharmaceuticals
Experience
Promega October 2013 - Present
Zimmer Dental January 2013 - July 2013
CareFusion August 2011 - December 2012
Aveva Drug Delivery Systems September 2010 - November 2011
Azopharma July 2007 - April 2010
Boston Scientific May 2006 - May 2007
Bolton Medical January 2003 - May 2006
Skills
Validation, V&V, Quality Assurance, Sop, CAPA, GMP, FDA, Testing, Change Control, Quality Control, Quality System
Education
Florida International University 2007 — 2010
Engineering, Mechanical Engineering
Southern Connecticut State University 1998 — 2002
BA, Engineering Technology in Quality Assurance
Promega October 2013 - Present
Zimmer Dental January 2013 - July 2013
CareFusion August 2011 - December 2012
Aveva Drug Delivery Systems September 2010 - November 2011
Azopharma July 2007 - April 2010
Boston Scientific May 2006 - May 2007
Bolton Medical January 2003 - May 2006
Skills
Validation, V&V, Quality Assurance, Sop, CAPA, GMP, FDA, Testing, Change Control, Quality Control, Quality System
Education
Florida International University 2007 — 2010
Engineering, Mechanical Engineering
Southern Connecticut State University 1998 — 2002
BA, Engineering Technology in Quality Assurance
Joe Mascetti's Bolton Medical Experience 2014 - Present
Job Sales Specialist Bolton Medical
Industry Medical Devices
Experience
Bolton Medical 2014 - Present
Omnia USA 2010 - 2014
Endologix Inc 2007 - 2010
Restore Medical 2006 - 2007
FoxHollow Technologies 2004 - 2005
Medtronic Vascular 1999 - 2004
CR Bard 1995 - 1999
Skills
Sales, Sales Management, Hiring, Negotiation, Project Planning, Medical Devices, Hospitals, Hospital Sales, Team Leadership, Marketing Strategy, Program Management, Vascular Surgery, Medical-Surgical, Entrepreneurship, Cardiology, Product Launch, Capital Equipment, Leadership, Market Development, Marketing, Product Development, Surgeons, Vascular, Sales Operations
Education
University of Missouri-Columbia
BA, Marketing/Marketing Management, General
Bolton Medical 2014 - Present
Omnia USA 2010 - 2014
Endologix Inc 2007 - 2010
Restore Medical 2006 - 2007
FoxHollow Technologies 2004 - 2005
Medtronic Vascular 1999 - 2004
CR Bard 1995 - 1999
Skills
Sales, Sales Management, Hiring, Negotiation, Project Planning, Medical Devices, Hospitals, Hospital Sales, Team Leadership, Marketing Strategy, Program Management, Vascular Surgery, Medical-Surgical, Entrepreneurship, Cardiology, Product Launch, Capital Equipment, Leadership, Market Development, Marketing, Product Development, Surgeons, Vascular, Sales Operations
Education
University of Missouri-Columbia
BA, Marketing/Marketing Management, General
Cari Kniola's Bolton Medical Experience July 2006 - November 2007
Job Sr. Project Manager, Medical Device & Diagnostics at Novella Clinical
Industry Research
Experience
Novella Clinical July 2015 - Present
Medical Research Network July 2014 - July 2015
Novella Clinical December 2012 - July 2014
Cari Kniola February 2011 - July 2014
PPD, Inc. November 2007 - December 2012
Bolton Medical July 2006 - November 2007
PPD June 2004 - July 2006
Skills
Clinical Research, Project Management, CRO, Clinical Monitoring, Clinical Trials, GCP, CTMS, EDC, eCRF, Global Management, Class III Medical..., Large Budget Management, Management, Project Team Management, Organization &..., Customer Service, Customer Support, Public Speaking, Clinical Management, Timeline Development, Timeline Management, Management of..., Media Planning, Marketing Plan Creation, Marketing Material..., Microsoft Office, Customer Oriented, Writing, Copy Editing
Education
Purdue University 1993 — 1996
BS, Veterinary/Animal Health Technology/Technician and Veterinary Assistant
Novella Clinical July 2015 - Present
Medical Research Network July 2014 - July 2015
Novella Clinical December 2012 - July 2014
Cari Kniola February 2011 - July 2014
PPD, Inc. November 2007 - December 2012
Bolton Medical July 2006 - November 2007
PPD June 2004 - July 2006
Skills
Clinical Research, Project Management, CRO, Clinical Monitoring, Clinical Trials, GCP, CTMS, EDC, eCRF, Global Management, Class III Medical..., Large Budget Management, Management, Project Team Management, Organization &..., Customer Service, Customer Support, Public Speaking, Clinical Management, Timeline Development, Timeline Management, Management of..., Media Planning, Marketing Plan Creation, Marketing Material..., Microsoft Office, Customer Oriented, Writing, Copy Editing
Education
Purdue University 1993 — 1996
BS, Veterinary/Animal Health Technology/Technician and Veterinary Assistant
Mark Gelardi's Bolton Medical Experience 2013 - 2014
Job Medical/Surgical Sales Professional
Industry Medical Devices
Experience
Medical Device 2014 - Present
Bolton Medical 2013 - 2014
Dendreon 2011 - 2013
Gore 2005 - 2008
Skills
Medical Devices, Biotechnology, Cardiology, Product Launch, Pharmaceutical Industry, FDA, Oncology, Healthcare, Market Development, Clinical Trials, Cross-functional Team..., Sales Operations, Pharmaceutical Sales, Sales
Education
University of New Hampshire
BS, Biochemistry
Medical Device 2014 - Present
Bolton Medical 2013 - 2014
Dendreon 2011 - 2013
Gore 2005 - 2008
Skills
Medical Devices, Biotechnology, Cardiology, Product Launch, Pharmaceutical Industry, FDA, Oncology, Healthcare, Market Development, Clinical Trials, Cross-functional Team..., Sales Operations, Pharmaceutical Sales, Sales
Education
University of New Hampshire
BS, Biochemistry
Disia House's Bolton Medical Experience 2008 - 2008
Job Sr. Therapy Development Specialist at Medtronic Corevalve
Industry Medical Devices
Experience
Medtronic July 2014 - Present
Edwards Lifesciences August 2010 - July 2014
Curesearch Children's Oncology Group 2008 - 2010
Bolton Medical 2008 - 2008
St. Jude Medical 2006 - 2008
St. Jude Medical 2004 - 2006
Skills
Medical Device Clinical..., Medical Device..., Cardiovascular Disease, Cardiovascular Imaging, Oncology Clinical..., Cardiac..., Endovascular, Cardiac Rhythm..., Sales, Literature Reviews, Design Control, Data Management, Clinical Research..., Cardiology, Clinical Trials, FDA
Education
University of Southern California 1998 — 2003
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Medtronic July 2014 - Present
Edwards Lifesciences August 2010 - July 2014
Curesearch Children's Oncology Group 2008 - 2010
Bolton Medical 2008 - 2008
St. Jude Medical 2006 - 2008
St. Jude Medical 2004 - 2006
Skills
Medical Device Clinical..., Medical Device..., Cardiovascular Disease, Cardiovascular Imaging, Oncology Clinical..., Cardiac..., Endovascular, Cardiac Rhythm..., Sales, Literature Reviews, Design Control, Data Management, Clinical Research..., Cardiology, Clinical Trials, FDA
Education
University of Southern California 1998 — 2003
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Vivian Kelly's Bolton Medical Experience March 2001 - May 2003
Job Regulatory Affairs Manager at Fidia Pharma USA
Industry Medical Devices
Experience
Fidia Pharma USA March 2014 - Present
Biomet April 2008 - March 2014
Stryker May 2003 - April 2008
Bolton Medical March 2001 - May 2003
Skills
FDA, ISO 13485, 510(k) submissions, PMAs, IDE, HDEs, Quality System, Process Improvement, MDD Technical Files and..., Regulatory Affairs, Regulatory Strategy..., CE marking, Medical Devices, Design Control, GMP, Regulatory Submissions, Regulatory Requirements, CAPA, R&D, Product Launch, Cross-functional Team..., Validation, Medical Device Directive, Orthopedics, 21 CFR, PMA, V&V, Product Development, Biologics, ISO 14971
Education
Rutgers, The State University of New Jersey-Newark
Bachelor of Science (BSc), Medical Techology
Seton Hall University
Master's degree, Biology/Biological Sciences, General
Fidia Pharma USA March 2014 - Present
Biomet April 2008 - March 2014
Stryker May 2003 - April 2008
Bolton Medical March 2001 - May 2003
Skills
FDA, ISO 13485, 510(k) submissions, PMAs, IDE, HDEs, Quality System, Process Improvement, MDD Technical Files and..., Regulatory Affairs, Regulatory Strategy..., CE marking, Medical Devices, Design Control, GMP, Regulatory Submissions, Regulatory Requirements, CAPA, R&D, Product Launch, Cross-functional Team..., Validation, Medical Device Directive, Orthopedics, 21 CFR, PMA, V&V, Product Development, Biologics, ISO 14971
Education
Rutgers, The State University of New Jersey-Newark
Bachelor of Science (BSc), Medical Techology
Seton Hall University
Master's degree, Biology/Biological Sciences, General
Marco Ceron's Bolton Medical Experience March 2011 - August 2012
Job Quality Engineer at Medtronic
Industry Medical Devices
Experience
Medtronic 2014 - Present
Boston Scientific September 2012 - March 2014
Bolton Medical March 2011 - August 2012
Boston Scientific July 2010 - March 2011
Skills
ISO 13485, Design Control, Medical Devices, CAPA, FDA, V&V, Quality System, Minitab, Design of Experiments, Validation, Biomedical Engineering, FMEA, SPC, Root Cause Analysis, DMAIC, Six Sigma, GMP, Lean Manufacturing, Design for Manufacturing
Education
Florida International University 2007 — 2010
Bachelor of Science (BS), Biomedical/Medical Engineering
Miami Dade College 2004 — 2006
Associate of Arts (AA), Mechanical Engineering
Medtronic 2014 - Present
Boston Scientific September 2012 - March 2014
Bolton Medical March 2011 - August 2012
Boston Scientific July 2010 - March 2011
Skills
ISO 13485, Design Control, Medical Devices, CAPA, FDA, V&V, Quality System, Minitab, Design of Experiments, Validation, Biomedical Engineering, FMEA, SPC, Root Cause Analysis, DMAIC, Six Sigma, GMP, Lean Manufacturing, Design for Manufacturing
Education
Florida International University 2007 — 2010
Bachelor of Science (BS), Biomedical/Medical Engineering
Miami Dade College 2004 — 2006
Associate of Arts (AA), Mechanical Engineering
Joe Mascetti's Bolton Medical Experience 2014 - Present
Job Sales Specialist at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical 2014 - Present
Omnia USA 2010 - 2014
Endologix Inc 2007 - 2010
Restore Medical 2006 - 2007
Fox Hollow Technology 2004 - 2005
Medtronic Vascular 1999 - 2004
CR Bard 1997 - 1999
Skills
Sales Management, Medical Devices, Endovascular, Sales Hiring, Negotiation, Hospitals, Drug Eluting Stents, Contract Negotiation, Direct Sales, Start-ups, Healthcare Reimbursement, Mentoring, Team Building, Cross-functional Team..., B2B, Forecasting, Marketing Strategy, Personal Development, Lead Generation, Social Media Marketing, Cardiology, Radiology, Peripheral Vascular
Education
University of Missouri-Columbia
Bachelor's Degree, Marketing
Bolton Medical 2014 - Present
Omnia USA 2010 - 2014
Endologix Inc 2007 - 2010
Restore Medical 2006 - 2007
Fox Hollow Technology 2004 - 2005
Medtronic Vascular 1999 - 2004
CR Bard 1997 - 1999
Skills
Sales Management, Medical Devices, Endovascular, Sales Hiring, Negotiation, Hospitals, Drug Eluting Stents, Contract Negotiation, Direct Sales, Start-ups, Healthcare Reimbursement, Mentoring, Team Building, Cross-functional Team..., B2B, Forecasting, Marketing Strategy, Personal Development, Lead Generation, Social Media Marketing, Cardiology, Radiology, Peripheral Vascular
Education
University of Missouri-Columbia
Bachelor's Degree, Marketing
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY