CardioFocus Company
Industry: Company
DescriptionFounded: 1990
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CardioFocus Employees
Dentsply Implants April 2013 - Present
Bruker Daltonics May 2011 - April 2013
CardioFocus October 2006 - May 2011
Boston Scientific September 2005 - October 2006
Skills
ISO 13485, CAPA, FDA, Validation, Medical Devices, Quality System, Design Control, R&D, Injection Molding, V&V, FMEA, GMP, ISO 14971, Manufacturing, Design of Experiments, ISO, Biotechnology, Product Development, Supplier Quality
Education
UMass Lowell
Bachelor of Science (BS), Plastics Engineering
UMass Lowell
MS, Pending 2013
Arnold Strategies, LLC January 2005 - Present
Boston Harbor Angels and Mass Med Angels 2006 - Present
Museum of Science 2014 - Present
MIT Venture Mentoring Society 2004 - Present
Corbus Pharmaceuticals 2012 - 2014
Coravin 2010 - 2011
CardioFocus 2001 - 2006
Cambridge Heart, Inc. 1993 - 2001
Molecular Simulations / Accelyrs 1990 - 1993
Skantek 1984 - 1988
Skills
Angel Investing, Strategic Partnerships, Venture Capital, Business Formation, Entrepreneurship, Medical Devices, Marketing Strategy, Strategic Planning, Lifesciences, Strategy, Mergers, Mergers & Acquisitions, Start-ups, Executive Management, Business Strategy, Commercialization, Product Development, Business Planning, Investments, Marketing, Venture Financing, Corporate Development, Due Diligence, Management, Biotechnology, Private Equity, R&D, Product Management, Business Development, Competitive Analysis, Finance, E-commerce, Licensing, Cross-functional Team..., Business Modeling, Management Consulting, Start-up Ventures, Technology Transfer, IPO, International Business, Team Building, Patents, Organizational..., Valuation, Financial Modeling, Strategic Consulting, Market Research, Product Launch, Biomedical Engineering, Consulting
Education
Massachusetts Institute of Technology 1967 — 1972
BS, Electrical Engineering
CardioFocus September 2014 - Present
Alkermes May 2014 - August 2014
ERP Systems Consultant April 2014 - April 2014
Viking Systems (acquired by Conmed Oct 2012) October 2007 - February 2014
Avidyne Corporation August 2004 - May 2007
Vishay BLH December 2003 - May 2004
HOUGHTON MIFFLIN June 2003 - December 2003
Candela Laser 1990 - 1995
Skills
MRP, Inventory Control, Logistics, Warehousing, Manufacturing, Forecasting, Purchasing, Management, Pricing, Project Planning, Sourcing, Materials Management, Supply Chain Management, ERP, Sales, Program Management
Education
Berklee College of Music 1987 — 1989
songwriting/performance
BERKLEE SCHOOL OF MUSIC WORCESTER STATE COLLEGE
Abiomed, Inc. October 2013 - Present
Light Lab Imaging, a St. Jude Company November 2011 - September 2013
Hologic January 2011 - November 2011
Interlace Medical November 2009 - November 2011
Interlace Medical August 2008 - November 2009
Helix Medical 2006 - 2008
Jenline, a division of Helix Medical LLC 2006 - 2008
Cardiofocus 2005 - 2006
Accellent, formerly MedSource Technologies 2004 - 2005
MedSource Technologies 2000 - 2005
Skills
Medical Devices, Manufacturing, Process Engineering, ISO 13485, V&V, Product Design, R&D, Product Development, Design of Experiments, Cross-functional Team..., CAPA, FDA, Quality System, Design for Manufacturing, Lean Manufacturing, Design Control, Plastics, Injection Molding, Continuous Improvement, Validation, Minitab, Six Sigma, FMEA, Root Cause Analysis, Manufacturing..., DMAIC, ISO 14971, ISO, Engineering, SPC, Biomedical Engineering, Machine Tools, Manufacturing..., Value Stream Mapping, Kaizen, Solidworks, GD&T, Quality Control, Manufacturing Operations, Machining, Start-ups, Process Improvement, Team Leadership, Plant Start Up, Clean Room Design, Quality Assurance, Product Launch, GMP, Management, Commercialization
Education
Northeastern University 1979 — 1983
Bachelor’s Degree, Mechanical Engineering
General Motors Institute 1977 — 1979
Mechanical Engineering
Bridgemedica, LLC January 2013 - Present
Woods Hole Oceanographic Institution 2008 - Present
Webb Research, Inc. 2004 - 2008
CardioFocus 2000 - 2004
Aerovox 1997 - 2000
IAP Research Inc. 1991 - 1997
Geo-Centers 1985 - 1991
Harris Corporation 1984 - 1985
Skills
Engineering, Labview, Data Acquisition, Telemetry, Systems Engineering, Automation, Instrumentation, Troubleshooting, Medical Devices, Manufacturing, Design for Manufacturing, Product Management, Electronics, R&D, Electrical Engineering, Robotics, Signal Processing, Sensors, Testing, Product Development, Embedded Software, Program Management, Simulations, Embedded Systems
Education
University of Massachusetts Lowell 1980 — 1984
BSEE
BShia Engineering, Inc April 2015 - Present
Vention Medical Design & Development June 2005 - April 2015
CardioFocus 2004 - 2005
ACMI 2002 - 2004
Covidien 2000 - 2002
Innovasive Devices 1997 - 2000
Boston Scientific 1989 - 1996
Skills
Medical Devices, Solidworks, Product Design, Product Development, Catheters, Medical Device Product..., Injection Molding, ISO 13485, FDA, Design Control, Design for Manufacturing, Design of Experiments, Biomedical Engineering, Validation, V&V, CAPA, ISO 14971, R&D, Minitab, Quality System
Education
Harvard University 1985 — 1989
Boston Latin School 1979 — 1985
Tegra Medical May 2010 - Present
STD MED June 2008 - April 2009
CardioFocus January 2007 - June 2008
Amgen December 2003 - January 2007
Dow Pharmaceutical Sciences May 2002 - December 2003
CI Medical April 2001 - May 2002
Ethicon, Inc., Mitek January 1998 - April 2001
Smith & Nephew Endoscopy June 1994 - January 1998
Skills
Medical Devices, Biopharmaceuticals, Calibration, Aseptic Technique, Testing, Sterilization, Software Documentation, Filtration, GLP, Quality Assurance, Biological Monitoring, FDA cGMP, Batch Record Review, Nonconformance Reporting, Deviation Investigations, Root Cause Analysis, CAPA, TrackWise System, CHO Cell Culture, CHO Cell WCB Thaw, Spinner Inoculum Train, Seed Bioreactor Train, Perfusion Culture M/E, Production Culture, CCF Harvest, Sterile Filtration, Normal Flow Filtration, Tangential Flow..., Microfiltration, Protein Purification, Protein A Chromatography, Viral Inactivation /..., Hydroxyapatite..., DEAE Chromatography, DV50 Viral Reduction, Ultrafiltration /..., BDS Fill / Freeze, Drug Fill / Finish, Lyophilization, Batch Release, Affinity Chromatography, Hydrophobic Interaction..., Ion Exchange..., Size Exclusion..., Visual Inspection, Dimensional Inspection, DHR Review, Quality Control, SOP's, Change Control
Education
Rhode Island College
Bachelor's Degree, Major: Industrial Technology, Minor: Biology, Cum Laude
Penn State University
Biotechnology Course: Mammalian Cell Culture Methods and Scale-up Strategies
Roger Williams University
Courses: Occupational Health and Industrial Hygiene
Independent Consultant June 2014 - Present
Cambridge Endoscopic Devices 2006 - June 2014
Independent Consultant April 2004 - May 2006
CardioFocus September 2002 - April 2004
MedSource Technologies 1998 - 2002
Skills
R&D, Medical Devices, Product Launch, Product Development, Manufacturing, Sop, Engineering, ISO 13485, FDA, Design for Manufacturing, Design Control, Biomedical Engineering, Machining, V&V, Quality System, Validation
Education
Massachusetts Institute of Technology 1982 — 1986
Bachelor of Science (B.S.), Aerospace, Aeronautical and Astronautical Engineering
Massachusetts Institute of Technology 1982 — 1986
Bachelor of Science (B.S.), Aerospace, Aeronautical and Astronautical Engineering
Cambridge Endoscopic Devices July 2012 - Present
Self Employed 2011 - Present
cardiofocus January 2008 - October 2010
Mitralign 2009 - 2010
Spectranetics 2002 - 2008
Somnus Medical 1999 - 2002
Target Therapeutics 1999 - 2000
Genzyme 1997 - 1999
CR Bard 1992 - 1997
Skills
FDA, ISO 13485, Biomedical Engineering, R&D, Capital Equipment, Cardiology, Biotechnology, Regulatory Affairs, Lifesciences, Medical Devices, Validation, Disposables, Vascular, Clinical Research, Clinical Trials, Quality System, Hardware Diagnostics, Global Marketing, V&V, Commercialization, Surgery, Market Development, Product Development, CAPA, Product Launch, Orthopedic, Interventional Radiology, Design Control, Interventional..., Cross-functional Team..., Catheters, Start-ups, Pharmaceutical Industry, Medical Imaging, Surgical Instruments, Surgeons, Oncology, Operating Room, Spine, Neurosurgery, Sales Effectiveness, Orthopedics
Education
Boston University 1973 — 1976
MBA, Finance
College of the Holy Cross 1966 — 1970
ba, pre-medicine
Clutch Group August 2008 - Present
Rush-Henrietta Alumni Council August 2006 - Present
United States India Political Action Committee (USINPAC) January 2005 - December 2008
Johnson & Johnson April 2008 - August 2008
Boston Scientific May 2007 - January 2008
Office of Governor Deval Patrick January 2007 - August 2007
Office of the Attorney General of New York June 2006 - January 2007
CardioFocus May 2006 - September 2006
Harvard Medical School/Brigham & Women's Hospital October 2004 - September 2006
Oxford Bioscience Partners October 2005 - February 2006
Skills
Medical Devices, Biotechnology, Biomedical Engineering, Lifesciences, Entrepreneurship, Corporate Law, Technology Transfer, Competitive Analysis, Litigation Support, Leadership, Marketing, Outsourcing, Strategy, Management, Lead Generation, Strategic Partnerships, Professional Services, Start-ups, Project Management, Mergers & Acquisitions, Legal Research, Strategic Planning, Business Development, Litigation, Business Strategy, Due Diligence, New Business Development, Public Speaking
Education
Boston University
BS, Biomedical Engineering
Rush Henrietta Senior High School
NASA Ames Research Center June 2010 - Present
KFJC Radio October 2009 - Present
HotelHosts Investment Group January 2004 - March 2009
CardioFocus May 2007 - May 2008
San Diego Unified School District September 2002 - August 2004
ACE Educational Services November 1999 - December 2002
Girl Scouts of Santa Clara County July 1998 - September 1998
Skills
User Interface Design, On Air Talent, Public Relations, Technical Writing, Online Marketing, Graphic Design, Virtual Teams, Teaching, Online Communications, Web Design, Web Analytics, Drupal, Online Advertising, Feature Articles, Educational Outreach, Dance, Marketing Communications, Partnerships, Feature Writing, Information Design, Outreach Programs, Dance Education, Digital Media, Digital Marketing, Marketing, Mobile Applications, Social Media, Photoshop, Copy Editing, User Experience, Strategy, Video, New Media, Social Networking, WordPress, Direct Marketing
Education
University of California, San Diego 1998 — 2003
BS, Cognitive Science
Foothill College 1993 — 2011
AA, Radio Broadcasting, Business Management
Leigh High School 1994 — 1998
CardioFocus February 2015 - Present
CardioFocus October 2009 - February 2015
Concordia Medical February 2007 - January 2010
Ximedica June 2006 - February 2007
Boston Scientific November 2003 - June 2006
Genzyme Biosurgery October 1999 - November 2003
Johnson & Johnson June 1997 - October 1999
Skills
FDA, Medical Devices, ISO 13485, Design Control, Quality System, Biomaterials, Orthopedic, Catheters, CAPA, ISO 14971
Education
University of Massachusetts Dartmouth 1998 — 2003
MBA, Management
Texas A&M University 1992 — 1993
MS, Industrial Engineering
University of Arizona 1988 — 1992
BS, Industrial Engineering
Cambridge BioMarketing July 2015 - Present
TeamOps, a division of Kraft Sports July 2000 - Present
Biogen Idec October 2009 - February 2015
UMASS Memorial July 2009 - October 2009
CardioFocus May 2007 - June 2008
Microsoft July 2004 - January 2007
TerraSure November 2002 - July 2004
Kinetics Biopharm April 1998 - October 2002
Century 21 - Taylor Realty June 1994 - February 1998
Skills
Marketing, Sales, Project Planning, Advertising, Cross-functional Team..., Process Improvement, Project Management, Vendor Management, Strategic Planning, Program Management, Budgets, Team Leadership, Management, Team Building, Contract Negotiation, Marketing Communications, Strategy, Product Launch, Pharmaceutical Industry, Marketing Strategy, Event Management, Leadership, Event Planning, Trade Shows, Social Media, Customer Service, Social Media Marketing, Biotechnology, Account Management
Education
Marist College 1990 — 1994
Bachelor of Arts, Communications; Public Relations and Marketing
Citizens Bank September 2015 - Present
Axis Communications March 2014 - Present
CardioFocus March 2012 - March 2014
Monster Worldwide July 2007 - July 2011
Monster July 2007 - November 2009
Bank of America March 2005 - July 2007
Bank of America 2005 - 2006
Skills
Microsoft Office, Adobe Acrobat, Dreamweaver, InDesign, Illustrator, Copywriting, Salesforce.com, Outlook, Marketing, Social Media, Social Networking, Travel Arrangements, Human Resources, Advertising, Marketing Communications, Management, Recruiting, Leadership, Project Management, Time Management, Event Planning
Education
Quinnipiac University 2000 — 2004
Bachelor of Arts
Bishop Feehan 1996 — 2000
CardioFocus May 2012 - Present
Beth Israel Deaconess Medical Center 2009 - May 2012
Medtronic April 1998 - July 2009
Angeion Corporation 1996 - 1998
Boston Scientific Corporation 1994 - 1997
Beth Israel Deaconess Medical Center December 1990 - March 1994
UMMC 1988 - 1990
Skills
Clinical, Nursing, Oncology, Clinical Trials, Clinical Research, Clinical Monitoring, Electrophysiology, Medical Devices, Cardiology, Clinical Trial..., GCP, ICH-GCP, Cancer, FDA, Neurology, Interventional..., Regulatory Submissions, Clinical Development, Clinical Data Management, EDC, CTMS
Education
Framingham State College 2010 — 2012
Bachelor of Science (BS), Nursing
St Elizabeth's School of Nursing 1983 — 1987
Nursing
Marian
Covidien 2012 - Present
CardioFocus 2007 - 2012
Aeris Therapeutics 2006 - 2007
Millennium Pharmaceuticals 2002 - 2006
Longview Orthopaedics 1995 - 2002
American Medical Response 1989 - 2002
Skills
Clinical Research, GCP, Clinical Monitoring, CTMS, Clinical Trials, ICH-GCP, FDA, Medical Devices, Regulatory Submissions, EDC, Regulatory Affairs, Biotechnology, Registered Nurses, Organizational..., Process Improvement, Critical Thinking, Resource Management
Education
Rivier University 2011 — 2013
Master of Business Administration (MBA)
Northern Essex Community College 2003 — 2005
ADN, Nursing
Colby Sawyer College 1985 — 1988
BS
Self-Employed October 2014 - Present
CardioFocus April 2012 - September 2013
IkaSystems September 2010 - January 2012
Humana May 2009 - September 2010
Humana November 2007 - May 2009
KLP Research Consulting January 2005 - January 2009
Multiple 1998 - 2005
Aperture Credentialing 1997 - 1998
Baptist Hospital East 1989 - 1997
Skills
Clinical Research, Clinical Trials, Healthcare, Clinical Monitoring, Nursing, Medical Devices, Pharmacovigilance, Quality Assurance, Managed Care, Data Analysis, Clinical Research..., Clinical Research..., Designing and selling..., Managed Care..., Change Management, Medical Device Safety, Managed Care..., Quality Improvement..., Clinical Outcomes and..., Process Improvement, Pharmaceutical Industry, GCP, FDA, Clinical Development, Protocol, Training, Regulatory Affairs
Education
Elmhurst College 1985 — 1988
Bachelor of Science, Nursing
Indiana University Bloomington 1979 — 1983
Business/Computer Programming
TDC Medical: A Vention Medical Company January 2014 - Present
CardioFocus January 2010 - Present
CardioFocus October 2005 - December 2009
LeMaitre Vascular April 2004 - October 2005
Cordis Corporation a Johnson and Johnson Company 2001 - 2004
Moog Inc. 1998 - 2001
Dept of Defense - Naval Air Warfare Center, Aircraft Division 1996 - 1998
Skills
Quality System, Solidworks, ISO 13485, Injection Molding, R&D, Validation, Plastics, Product Development, Manufacturing, Design of Experiments, Biomedical Engineering, FMEA, Process Improvement, CAPA, ISO 14971, V&V, Design for Manufacturing, Engineering, ISO
Education
State University of New York at Buffalo 1987 — 1996
Master of Science (MS), Mechanical & Biomedical Engineering
CardioFocus July 2013 - Present
Project Leadership Services April 2012 - June 2013
Kalypto Medical October 2008 - April 2012
Project Leadership Services (PLS) May 2007 - October 2008
St. Jude Medical May 2005 - April 2007
Velocimed, LLC April 2003 - April 2005
Portex Inc. January 2002 - March 2003
Boston Scientific 1998 - 2001
Skills
Medical Devices, CAPA, ISO 13485, Start-ups, Cross-functional Team..., Quality System, FDA, Design Control, V&V, Continuous Improvement, Organizational..., Lean Management, Strategic Planning, Lean Manufacturing
Education
Lesley University 1992 — 1994
MS, Management
Northeastern University 1977 — 1982
BS, Industrial Engineering
RAPS February 2004 - Present
The Curtis Group, LLC January 2003 - Present
Bridgemedica June 2010 - January 2014
the curtis group,llc 2003 - 2010
MediSpectra 2006 - 2007
Cardiofocus 2001 - 2002
Boston Scientific Corporation 1993 - 2001
St. Jude Medical February 1991 - May 1993
C.R. Bard 1987 - 1991
meadox medicals 1985 - 1987
Skills
Medical Devices, Design Control, FDA, CAPA, ISO 14971, ISO 13485, V&V, Quality System, Regulatory Affairs, Biomedical Engineering, Regulatory Submissions, Validation, PMA, Quality Auditing, GMP, Quality Assurance, 21 CFR, Catheters, Product Launch, 21 CFR Part 11, Change Control, Design of Experiments, R&D, Regulatory Requirements, CE marking, Commercialization, GLP, Biopharmaceuticals, Medical Device Directive, Technology Transfer
Education
Quinnipiac University
Radiologic Technology/Science - Radiographer
GI Dynamics January 2015 - Present
Sorin Group May 2012 - January 2015
CardioFocus 2009 - 2011
MetroWest Medical Center October 2007 - June 2009
GUIDANT CORPORATION September 2002 - August 2007
2006-2007 August 2006 - July 2007
NEW ENGLAND MEDICAL CENTER January 1998 - January 2002
NEW ENGLAND MEDICAL CENTER January 1993 - January 1998
Skills
Clinical Research, Medical Devices, Cardiology, Heart Failure, Oncology, Clinical Monitoring, CTMS, GCP, Interventional..., Electrophysiology, ICH-GCP, FDA, Clinical Data Management, EDC
Education
Framingham State University 2008 — 2010
MSN, Nursing Education
University of Massachusetts, Boston 1989 — 1992
Bachelor of Science, Nursing
Fletcher Spaght, Inc. 1992 - Present
CardioFocus June 2009 - Present
Boston University 2013 - 2014
Ikano Therapeutics September 2006 - November 2010
Axya Medical 2003 - 2006
The Boston Consulting Group 1990 - 1991
Motorola 1984 - 1988
Skills
Marketing Strategy, Consulting, Funding, Medical Devices, Start-ups, Venture Capital, Commercialization, Corporate Development, Product Development, Strategic Planning, Product Management, Mergers, Product Marketing, Competitive Analysis, Mergers & Acquisitions, Entrepreneurship, Management Consulting, Business Development, Strategy, Healthcare, Due Diligence, Business Planning, Biotechnology, R&D, Cross-functional Team..., Market Research, Strategic Partnerships, Analysis, Business Strategy
Education
University of Pennsylvania - The Wharton School 1988 — 1990
MBA, MA
Massachusetts Institute of Technology 1979 — 1983
SB, Engineering
CardioFocus Engineering DirectorMedsource TechnologiesDecember 2000 - May 2002
ACT Medical May 1996 - December 2000
Skills
Engineering, Capital Equipment, Product Development, Commercialization, FDA, Cross-functional Team..., Design Control, Surgical Instruments, Medical Devices, ISO 13485, Design for Manufacturing, R&D, Biomedical Engineering, Biotechnology, Product Launch
Education
Massachusetts Institute of Technology 1976 — 1982
MS, Engineering
KEO Milling Cutters July 2014 - Present
CardioFocus January 2013 - July 2014
RANOR/ TECHPRECISION June 1998 - July 2012
MEDCARE MEDICAL GROUP, INC October 1989 - June 1998
First Northern Bank June 1987 - October 1989
Skills
Cost Accounting, Financial Reporting, General Ledger, Accounting, GAAP, Internal Controls, Cash Flow, Accounts Receivable, Accounts Payable, Manufacturing, Forecasting, Fixed Assets, Sarbanes-Oxley Act, Financial Accounting, Cash Management, US GAAP, Auditing, Financial Analysis, Process Improvement, Variance Analysis, Account Reconciliation, Analysis, Cash Flow Forecasting, Consolidation, Depreciation, Financial Modeling, Finance, Monthly Close, SEC filings, Journal Entries, Internal Audit, Hyperion Enterprise, Payroll, Balance, Year-end Close, Payroll Taxes, Management, ERP, Financial Forecasting, Strategic Planning, Financial Statements, Budgets, External Audit, Accruals, Revenue Recognition, Strategic Financial..., Employee Benefits, Financial Audits, MIS, Bank Reconciliation
Education
Fitchburg State University
MBA, Accounting
Franklin Pierce University
Bachelor of Science, Accounting
Mount Wachusett Community College
Associates, Data Processing and Business Technology
Cardiofocus 2000 - 2013
Education
Denison University 1973 — 1977