TransMedics, Inc.
Industry: Company
DescriptionTransMedics, Inc., headquartered in Andover, Massachusetts, is a medical device company founded to address the unmet need for more and better organs for transplantation. Headquarters: Andover, MA Founded: 1998 Type of business: Private
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TransMedics, Inc. Employees
Iscon Imaging, Inc. June 2015 - Present
BAE Electronic Systems, September 2014 - Present
Bruker Biospin March 2011 - December 2013
Gerber Innovations June 2010 - December 2010
GE Healthcare July 2007 - August 2008
TransMedics, Inc. June 2006 - June 2007
Brooks Automation June 2004 - August 2006
GSI Lumonics October 2002 - May 2004
Lucent Technologies March 2000 - April 2001
Skills
Electrical..., Reverse Engineering, Manufacturing..., AutoCAD, NI LabVIEW, Test Fixtures, Process Improvement, Prototype, Breadboard, Management, Teaching, Technical Writing, Production Support, Wiring, Technical Documentation, Troubleshooting, Semiconductors, Medical Devices, Electronics, Testing, PCB design, PCB Design
Education
Northeastern University, Bachelors Computer Engineering 1991 — 1995
Bachelor of Science, Computer Engineering
Northeastern University, Bachelors Industrial Engineering 1991 — 1995
Bachelor of Science, Industrial Engineering [Electronics Concentration]
Northeastern University, Associates Business Administration 1991 — 1995
Associate's degree, Business Administration and Management, 3.9
University of Massachusetts Lowell 1994 — 1995
Multimedia
Bruker Instruments, Billerica, MA 1987 — 1988
Nuclear Magnetic Resonance Spectrometer repair and maintenance
Merrimack College, North Andover, MA 1986 — 1987
Chemical Instrumentation for Professionals (infrared spectroscopy, gas chromatography, lasers,, atomic absorption, electrochemistry and nuclear magnetic resonance)
Echo Therapeutics January 2014 - December 2014
iWalk March 2012 - December 2012
TransMedics, Inc. July 2008 - March 2012
TransMedics Inc July 2007 - July 2008
TransMedics Inc. March 2004 - July 2007
Quarry Technologies February 1999 - March 2004
Analogic February 1997 - February 1999
Siemens Medical Systems 1987 - February 1997
Skills
Software, Embedded Systems, R&D, Medical Devices, ISO 13485, Start-ups, Design Control, Automation, Medical Monitoring, C++, Device Drivers, Biomedical Engineering, Product Development, Engineering, Testing, Strategy, Software Engineering, Embedded Software, Manufacturing, Management, Cross-functional Team..., Systems Engineering, Quality Assurance, Product Launch, Project Management, Software Development, Integration, Electronics, System Architecture
Education
Denison University 1974 — 1979
Bachelor of Arts (B.A.), Computer Science
Philips Healthcare August 2013 - Present
Thoratec December 2012 - August 2013
GE Healthcare( Special MR) October 2011 - December 2012
TransMedics, Inc. April 2008 - October 2011
GE Healthcare-Surgery and Navigation January 2007 - March 2008
Kollsman January 2000 - December 2006
Education
Southern New Hampshire University 2014 — 2016
Master's degree, Operations Supply Chain Management
Wentworth Institute of Technology 2000 — 2002
Bachelor's degree, Electronics Engineering
Itt tech
Bachelor's degree, Electronics and Communication Engineering Technology
Digital Guardian January 2015 - Present
LoadSpring Solutions, Inc. August 2012 - December 2014
Surveillance Specialties (SURV) April 2010 - August 2012
TransMedics, Inc. April 2008 - April 2010
Skills
Network Administration, VMware Infrastructure, Windows Server, Linux System..., Windows System..., Customer Service, HTML, Powershell, Strategic Planning, Secure Network..., VMWare Orchestrator, Datacenter..., Data Centre Architecture, Network Monitoring Tools, Storage Management, Creative Problem Solving, PowerPoint, English, Research, Public Speaking, Budgets, Teaching, C++, Java
Education
University of Massachusetts Lowell 2007 — 2011
BS, Information Technology
Wentworth Institute of Technology 2006 — 2007
Bachelor of Science (BS)
Cynosure, Inc. 2014 - Present
Boston Heart Diagnostics 2012 - 2013
Thermo Fisher Scientific 2010 - 2012
PhotoDetection Systems, Inc. 2008 - 2010
TransMedics, Inc. 2007 - 2008
EXACT Sciences Corporation 2001 - 2007
Abiomed 1999 - 2001
HP Medical (now Philips Healthcare) 1995 - 1999
GE Healthcare 1988 - 1993
Skills
Medical Devices, Product Management, Strategic Planning, Leadership, Start-ups, Healthcare, Product Development, Marketing Strategy, Strategy, Management, Product Marketing, Commercialization, Product Launch, Marketing, Biotechnology, Cross-functional Team..., Business Development, Program Management, Clinical Research, Sales, Competitive Analysis
Education
Harvard Business School 1993 — 1995
MBA
University of Vermont 1984 — 1988
BSME, Mechanical Engineering
TransMedics, Inc. June 2014 - Present
Brigham and Women's Hospital March 2013 - May 2014
Hospital for Sick Children February 2012 - January 2013
Hospital for Sick Children May 2011 - January 2013
Ministry of Community and Social Services February 2011 - April 2011
Hospital for Sick Children January 2010 - December 2010
Marvdasht Azad University September 2007 - September 2009
Shiraz University of Medical Sciences September 2006 - August 2007
Shiraz University of Medical Sciences September 2004 - August 2006
Skills
having experience in..., Being familiar with..., Clinical Research, Biostatistics, Clinical Trials, Oncology, Lifesciences, Data Management, Pharmaceutical Industry, GCP, Regulatory Affairs, Cardiology, SAS, SPSS, Qualitative Research, Quantitative, SAS programming, Epidemiology, Statistics, Public Health, EDC, Clinical Study Design, Data Collection, Protocol, Validation, Clinical Data Management, Infectious Diseases, Sop, Clinical Development, CTMS, Medical Writing, Literature Reviews, Neuroscience, ICH-GCP, Cancer, Statistical Programming, CRO, Immunology, Scientific Writing, Drug Development, Medical Research, Health Economics, Regulatory Submissions, Global Health, Molecular Biology, Survival Analysis, Experimental Design, R, Pharmacovigilance, Bioinformatics
Education
University of Massachusetts, Amherst 2014 — 2018
Doctor of Philosophy (Ph.D.), Epidemiology
McMaster University 2010 — 2012
Master of Science (M.Sc.), Health Research Methodology (Stream: Population and Public Health), A
Shiraz University of Medical Sciences 2004 — 2007
Master of Science (M.Sc.), Biostatistics, A+
Shiraz University 1999 — 2003
Bachelor of Science (B.Sc.), Statistics
Alcresta Pharmaceuticals August 2015 - Present
CIRTEC Medical Systems July 2014 - August 2015
TransMedics, Inc. April 2014 - July 2014
Valeritas October 2011 - October 2013
Tegra Medical December 2009 - October 2011
Accellent, Inc May 2007 - December 2009
BD Biosciences May 2005 - May 2007
ConMed Endoscopic Technologies 2005 - 2005
TRW Automotive 1997 - 2005
University of Massachusetts Lowell January 2002 - March 2004
Skills
Project Management, Product Development, Plastic Injection..., Manufacturing Line..., Process IQ/OQ/PQ..., MS Project, Injection Molding, Manufacturing, V&V, Cross-functional Team..., Engineering, FDA, Medical Devices, Continuous Improvement, Plastics, Lean Manufacturing, Six Sigma, Kaizen, Extrusion, Management, DMAIC, Program Management, Product Launch, ISO 13485, FMEA, Design Control, Quality System, GMP, R&D, Design of Experiments, Validation, Design for Manufacturing, Process Engineering, SPC, Root Cause Analysis, Engineering Management, Minitab, Manufacturing..., CAPA, Machining, ISO, Manufacturing..., Quality Assurance, Value Stream Mapping, Molding, Operational Excellence, Process Improvement, Machine Tools, Process Simulation, 5S
Education
University of Massachusetts Lowell 1979 — 1984
BS, Plastics Engineering
University of New Hampshire - Whittemore School of Business and Economics
Master of Business Administration (M.B.A.), Executive MBA classes
International Institute for Learning 2006 — 2006
Certificate, Project Management
Boston College High School 1975 — 1979
College/University Preparatory and Advanced High School/Secondary Diploma Program
Beverly Hospital September 2014 - Present
Beverly Hospital January 2013 - August 2014
Community Work Services October 2009 - August 2012
Health and Education Services-Nexus House October 2007 - September 2009
TransMedics, Inc. 2004 - 2006
Skills
Workforce Development, Social Services, Motivational..., Vocational..., Community Outreach, Case Managment, Diagnostic Ultrasound, PACS, Meditech, Patient Safety, HIPAA, First Aid, Cpr Certified, Career Counseling, Case Management, Job Search Strategies, Mental Health, Resume Writing, Crisis Intervention
Education
Middlesex Community College 2012 — 2014
Associate of Science (AS), Diagnostic Medical Sonography/Sonographer and Ultrasound Technician
Merrimack College 2003 — 2007
BA, Sociology, Social Psychology
TransMedics, Inc. July 2014 - Present
Thermo Fisher Scientific May 2012 - July 2014
Velico Medical May 2011 - May 2012
Smiths Medical 2009 - May 2011
Vectron International August 2006 - October 2007
Vishay Transducer Inc April 2004 - June 2006
Analogic Corporation May 1996 - November 2003
Innov-x Systems Corp 1989 - 1995
Skills
Electronics, Embedded Systems, Six Sigma, Firmware, Manufacturing, C, Testing, Product Management, Medical Devices, Analog, Software Documentation, Design for Manufacturing, Hardware Architecture, Manufacturing..., Engineering Management, Product Launch, Microcontrollers, Lean Manufacturing, PCB design, Continuous Improvement, Software Engineering, Engineering, Product Development, FDA, Instrumentation, R&D, PCB Design, RF, Electrical Engineering, Sensors
Education
Tufts University 1998 — 2000
MS, Engineering Management
Wentworth Institute of Technology 1989 — 1994
Electrical Engineer, EBSEE
DPI ( Dimensional Photonics International May 2011 - Present
ZOLL Medical Corporation 2015 - 2015
ZOLL Medical Corporation 2015 - 2015
DPI 2011 - 2014
TransMedics, Inc. March 2010 - October 2010
BARD EP October 2009 - March 2010
Philips Healthcare 1990 - 2008
Hewlett Packard Medical Products 1990 - 2008
Potomac Systems Engineering 1986 - 1988
International Business Machines 1983 - 1986
Skills
Configuration Management, Automation, CMMI, User Interface, Process Simulation, IV&V, Quality System, Systems Engineering, Software Quality, Software Quality..., Testing, Validation, SDLC, Embedded Software, Test Automation, Medical Devices, FDA, Embedded Systems, ISO 13485, Quality Assurance
Education
Howard University 1988 — 1990
MS, Computer Science
Howard University 1980 — 1983
BS, Electrical Engineering
TransMedics, Inc. September 2012 - Present
Granite State Weddings January 2012 - Present
Danville Fire Department June 2009 - Present
New England Organ Bank October 2011 - September 2012
Work Opportunities Unlimited January 2010 - September 2011
StartAcuity Scientific 2009 - 2009
Skills
Biotechnology, Clinical Research, Medical Devices, FDA, Surgery, Healthcare, Management, Fundraising, Event Planning
Education
University of New Hampshire 2005 — 2009
BS, Biology
Elmer L. Herman Funeral Home 2014 - Present
TCOA January 2011 - Present
International Institute for Advancement for Medicine January 2010 - Present
IIAM International Institute for Advancement of Medicine April 2011 - January 2012
Ventracor June 2008 - February 2009
TransMedics, Inc. September 2007 - June 2008
Alphacor September 2006 - September 2007
CORE June 2003 - September 2006
Skills
Medical Devices, Clinical Research, Biotechnology, Healthcare, FDA, Clinical Trials, Lifesciences, Hospitals, Cardiology, Surgery, Research, Project Management, R&D, GMP, Sop, Oncology, Healthcare Information..., Healthcare Management, Life Sciences
Education
Pittsburgh Institute of Mortuary Science Inc 2012 — 2013
Rosemont College 2001 — 2003
Bachelor of Science, Forensic Science
TransMedics, Inc. December 2013 - Present
Boston Scientific April 2013 - January 2014
Ministerio de Educación August 2011 - April 2013
Ithaca College May 2009 - January 2011
Roswell Park Cancer Institute August 2008 - January 2010
Skills
Event Planning, Leadership, Microsoft Word, Research, Public Speaking, Microsoft Excel, Social Media, Microsoft Office, Teaching, PowerPoint, Facebook, Sales, English, Medical Devices, Clinical Research, Healthcare, Hospitals, Clinical Trials, FDA, Social Networking, Spanish, Customer Service, Management, Surgeons
Education
Universidad Autónoma de Madrid 2013 — 2013
Post Graduate Studies, Business/Managerial Economics
Ithaca College 2007 — 2011
Bachelor of Science, Biology, Spanish
University of Alicante 2010 — 2010
Spanish Studies, Spanish
Boston Biomedical April 2015 - Present
Medivector Inc September 2014 - February 2015
Cytel September 2013 - September 2014
TransMedics, Inc. March 2010 - March 2013
SYNDAX PHARMACEUTICALS September 2009 - March 2010
Pfizer (formerly Wyeth) December 2007 - March 2009
Dana Farber November 2003 - November 2007
Skills
Clinical Trials, Medical Devices, EDC, Data Management, Pharmaceutical Industry, GCP, CRO, CTMS, Clinical Data Management, Clinical Development, FDA, Oncology, Validation, Sop, Biotechnology, Inform, Oracle Clinical, Clinical Monitoring, Clinical Research, 21 CFR Part 11, ICH-GCP, GMP, Regulatory Affairs, Lifesciences, CRF design, Protocol, Computer System..., Cross-functional Team..., Regulatory Submissions, Therapeutic Areas, Pharmacovigilance, Infectious Diseases, Cardiology, CDISC, Regulatory Requirements, CAPA, Quality Assurance, Medidata, Life Sciences, SAS
Education
Nichols College 1996 — 1998
MBA, Business Administration and Management, General
Nichols College 1996 — 1998
Master of Business Administration (M.B.A.), Business Administration, Management and Operations
Capsule Technologie June 2014 - Present
Capsule Technologie January 2014 - June 2014
Capsule Technologie January 2013 - December 2013
Capsule Technologie February 2011 - December 2012
Capsule Technologie March 2009 - February 2011
TransMedics, Inc. April 2006 - February 2009
McKesson Provider Technologies April 2005 - March 2006
US Genomics February 2002 - August 2004
Shriners Hospitals for Children August 2000 - January 2002
Skills
Lifesciences, Medical Devices, Healthcare, Healthcare Information..., Product Development, Biotechnology, Cross-functional Team..., Product Marketing, Hospitals, Product Launch, Strategic Planning, Market Analysis, Management, Marketing Strategy, Marketing, Business Development, Sales
Education
Boston College - Wallace E. Carroll Graduate School of Management 2004 — 2006
MBA, Finance & Marketing
Hobart and William Smith Colleges 1996 — 2000
BS, Biochemistry
Medtronic Minimally Invasive Therapies Group August 2015 - Present
TransMedics, Inc. October 2014 - August 2015
Allergan April 2011 - October 2014
ConMed Corporation November 2008 - April 2011
Cmed 2007 - 2008
Goodwill Industries of Greater Detroit 2006 - 2006
Schutte Meyer Impex Ltd 2004 - 2005
Skills
SPC, Lean Manufacturing, Six Sigma, Supplier Management, Product Development, Process Engineering, V&V, Manufacturing, Medical Devices, ISO 13485, Supply Management, Engineering, Manufacturing..., Supply Chain Management, Industrial Engineering, Quality System, FDA, Validation
Education
Wayne State University 2005 — 2007
Master's, Industrial Engineering
Bharathiar University 2000 — 2004
Bachelor's, Mechanical Engineering
Smith & Nephew Endoscopy May 2013 - Present
Smith & Nephew Endoscopy November 2012 - May 2013
Insulet Corporation March 2012 - August 2012
GnuBIO, Inc December 2011 - May 2012
TransMedics, Inc. 2010 - 2011
Ahura Scientific September 2008 - January 2009
GE Healthcare January 2008 - September 2008
Varian Semiconductor April 2006 - December 2007
ZOLL Medical Corporation September 2005 - August 2006
MKS Instruments April 2006 - June 2006
Skills
Medical Devices, FDA, ISO 13485, Quality System, Quality Assurance, Design Control, CAPA, Validation, Manufacturing, Labview, Testing, Engineering, Troubleshooting, Biotechnology, Lean Manufacturing, Six Sigma, Quality Management, GMP, Biomedical Engineering, Semiconductors, V&V, Advanced Soldering for..., LEAN DFSS, Six Sigma Green Belt..., Quality Auditing
Education
Alexandria University
Bachelor's degree, Civil and Industrial Engineering
Alexandria Technical School , Alexandria- Egypt 1992 — 1997
Advanced Technical, Computer Science & Electronics Technology
Bunker Hill Community College 2000 — 2002
Associate Degree in Science, Electronics Technologies
CR Bard January 2011 - Present
MassMEDIC 2003 - 2011
TransMedics, Inc. August 2007 - December 2010
Medtronic Vascular 2000 - 2007
Becton Dickinson January 1987 - June 2000
Skills
Manufacturing, Management, Product Development, Strategy, ISO 13485, Medical Devices, Quality System, Design Control, FDA, Leadership, Engineering Management, Outsourcing, Cross-functional Team..., V&V, Design of Experiments, CAPA
Education
Rutgers University-New Brunswick 1980 — 1984
BSME, Mechanical Engineering
Edwards Lifesciences August 2009 - Present
Xcorporeal, Inc. April 2007 - March 2009
Gish Biomedical March 2001 - April 2007
TransMedics, Inc. 1999 - 2001
Sorin Group June 1997 - November 1999
Sorin Biomedical June 1997 - November 1999
Baxter Healthcare - Paramax November 1983 - May 1997
Baxter Healthcare November 1983 - May 1997
Education
University of Southern California 1994 — 1999
MS, Systems Engineering
Temple University 1974 — 1976
MS, Biochemistry
Rhode Island Hospital 1973 — 1974
Certificate, Medical Technology
Southeastern Massachusetts University 1970 — 1974
BS, Medical Technology
University of Massachusetts Dartmouth 1970 — 1974
BS, Medical Technology
Telligen January 2015 - Present
Masspro November 2007 - November 2014
Inflexxion October 2006 - November 2007
Boston University September 2005 - May 2006
TransMedics, Inc. September 2004 - September 2005
Skills
COMPUTER..., Research, Biostatistics, Statistics, Report Writing, Grant Writing, Statistical Data..., Statistical Analysis..., Clinical Study Design, SAS, Epidemiology, Analysis, Data Analysis, Clinical Research, Logistic Regression, Protocol, Statistical Modeling, SAS Programming, R, SPSS
Education
Boston University
Doctor of Philosophy (PhD Candidate), Biostatistics
Boston University
Master of Science (MS), currently PhD candidate, Biostatistics
Calcutta University
Master's degree, Statistics
TransMedics, Inc. December 2013 - Present
Optos March 2012 - November 2012
Covidien November 2009 - January 2012
Aspect Medical Systems January 2009 - November 2009
Aspect Medical Systems May 2006 - January 2009
Aspect Medical Systems September 2003 - May 2006
Gillette September 2000 - September 2003
Gillette March 1999 - September 2000
Skills
Financial Analysis, Forecasting, Budget, Gross Margin, Balance Sheet, KPI Dashboards, Accounts Payable, Cost Accounting, Financial Reporting, Financial Modeling, Financial Audits, Inventory Analysis, Physical Inventory, Inventory Accuracy, Standards Development, Spend Analysis, Absorption, Capital Budgeting, Budgets, Process Improvement, Medical Devices, ERP Implementations, Integration, MFG-Pro, SAP, JDE, BPCS, Oracle, GP-Dynamics, Essbase, Hyperion Enterprise, Cognos Planning -..., Manufacturing, Revenue Recognition
Education
Northeastern University 1995 — 1999
BSBA, Finance
University of Massachusetts Boston 1993 — 1995
Transferred, Finance
Toxikon Corporation August 2015 - Present
Toxikon Corporation 2011 - Present
Toxikon Corporation May 2008 - Present
TransMedics, Inc. August 2007 - April 2008
Charles River Laboratories November 2006 - August 2007
Charles River Laboratories March 2002 - November 2006
Skills
Microsoft Office, Microsoft Excel, Research, Leadership, Training, Microsoft Word, Management, Process Improvement, Windows, Outlook, PowerPoint, Interviews, Protocol Development, Dosing techniques, Biocompatibility, Surgical Services, Anesthesia, Purchasing, Sourcing, Clinical Research, FDA, GLP
Education
Universidad Cooperativa de Colombia 1991 — 1996
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
Northern Essex Community College
Train the Trainer Course
Transmedics, inc. October 2013 - Present
Dow Water and Process Solutions July 2012 - September 2013
The Dow Chemical Company July 2011 - July 2012
Low Sweeper LLC April 2008 - May 2011
United Cleaners September 2007 - April 2008
Skills
Supply Chain, Cross-functional Team..., Supply Chain Management, Six Sigma, Supply Chain..., Inventory Management, Leadership, Continuous Improvement, Manufacturing, Global Sourcing, Management, Strategic Sourcing, Process Improvement, Project Management, Strategy, Logistics, Materials Management, SAP, Process Engineering, Lean Manufacturing, Operational Excellence, Warehousing, Microsoft Office, Product Development, Inventory Control, AutoCAD, Business Process..., VBA, Patents, Product Design, QAD
Education
MSU 2008 — 2011
Bachelor of Arts (B.A.), Supply Chain Management
TransMedics, Inc. September 2012 - Present
Catholic Medical Center May 2011 - September 2012
Catholic Medical Center January 2008 - May 2011
Skills
Nursing, Healthcare, Hospitals, Healthcare Information..., Clinical Research, Acute Care, ICU, Medical Devices, Clinical Trials, Clinical Monitoring, Clinical Development, Research, Product Development, Microsoft Excel, PowerPoint, Data Analysis, Data Entry, Presentation Development, Written & Oral..., Critical Care, Patient Safety, ACLS, Nursing Education, Surgery
Education
Georgetown University 2013 — 2014
ACNP/CNS, Nursing Education
Northeastern University 2012 — 2013
Acute Care Nurse Practitioner Program, Critical Care Nursing
University of New Hampshire 1999 — 2003
B.S. in Nursing, Registered Nursing/Registered Nurse
TransMedics, Inc. March 2010 - Present
Sagent Healthstaff March 2007 - March 2010
AMN Healthcare June 2004 - March 2007
Skills
Medical Devices, Clinical Research, Surgery, Hospitals, Clinical Trials, Oncology, Cardiology, Healthcare, Critical Care, GCP, CTMS, FDA, Clinical Monitoring, Clinical Development, Biotechnology, ACLS, Transplant, CRO, ICH-GCP, Lifesciences
Education
Fitchburg State College
Bachelor of Science (BS), Registered Nursing/Registered Nurse
TransMedics, Inc. January 2013 - Present
TransMedics, Inc. June 2010 - January 2013
UCLA Medical Center 2007 - 2009
UCLA Health System 2007 - 2009
University of Washington 2003 - 2007
Skills
Clinical Research, Lifesciences, Transplant, Data Analysis, Medical Devices, Clinical Trials, Biotechnology, Public Health, Research, EDC, CRO, Oncology, Cardiology, FDA, Clinical Development, Life Sciences
Education
Geisel School of Medicine at Dartmouth 2009 — 2010
MS, Clinical/Heath Services Research
University of Washington
BS, Psychology
480 Biomedical, Inc. May 2011 - November 2012
TransMedics, Inc. August 2010 - May 2011
PerkinElmer October 2008 - August 2010
Boston Scientific December 2006 - October 2008
Boston Scientific Corp December 2004 - November 2006
Boston Scientific Corp April 2004 - November 2004
Quintiles August 2000 - March 2004
Biogen Idec June 1999 - August 2000
Skills
Clinical Trials, Clinical Research, Clinical Monitoring, Clinical Protocols, Vendor Management, Budget, Medical Devices, Peripheral Vascular, Cardiology, Gastroenterology, Oncology, invitro dignostics, Clinical Development, GCP, CRO, Data Management, EDC, FDA, Biotechnology, Sop, Therapeutic Areas, Validation, Pharmaceutical Industry, Budgets
Education
Boston University - School of Public Health 2001 — 2002
MPH, Public Health, Environmental Health
Bates College 1995 — 1999
BS, Biology, Spanish
HeartWare Inc April 2011 - Present
HeartWare Inc March 2009 - May 2011
TransMedics, Inc. April 2006 - February 2009
Draeger Medical Systems 2004 - 2006
Siemens Medical Systems July 1986 - July 2004
Analogic May 1984 - July 1986
Norland Corporation June 1981 - May 1984
Cordis Corporation July 1978 - June 1981
Skills
Medical Devices, Engineering, PCB design, Troubleshooting, Electrical Engineering, Design Control, FMEA, ISO 13485, ISO 14971, Project Management, Testing, R&D, Quality Assurance, GMP, V&V, CAD, Electronics, Medical Monitoring, Analog, Cross-functional Team..., CAPA, PCB Design
Education
Duke University 1974 — 1978
BSE, Biomedical Engineering/Electrical Engineering
TransMedics, Inc. November 2007 - Present
Abiomed October 2000 - November 2007
Skills
Product Development, Engineering, Medical Devices, Design for Manufacturing, Engineering Management, R&D, Pro Engineer, Biomedical Engineering, Injection Molding, FMEA, Design of Experiments, Manufacturing..., V&V, Design Control, ISO 13485, Thermal System Design, SolidWorks
Education
University of Michigan 1994 — 1994
M.S., Biomechanical Engineering
Massachusetts Institute of Technology 1985 — 1989
B.S., Mechanical Engineering
Genzyme sanofi December 2012 - Present
sanofi-aventis May 2011 - December 2012
TransMedics, Inc. 2004 - May 2011
Boston University School of Public Health 2000 - 2004
Skills
Biotechnology, CRO, CTMS, Cardiology, Clinical Development, Clinical Research, Clinical Trials, Data Management, EDC, GCP, Lifesciences, Medical Devices, Oncology, Pharmaceutical Industry, Product Launch, Regulatory Affairs, Life Sciences, Drug Development
Education
Boston University - School of Management 2001 — 2003
Master of Business Administration (MBA)
Boston University School of Public Health 1999 — 2001
Master of Public Health (MPH)
PPD Manager Clinical Data ManagementPPDAugust 2015 - Present
PPD November 2014 - Present
Lackawanna College November 2012 - July 2015
Arteriocyte June 2012 - October 2014
Quintiles August 2011 - April 2012
TransMedics, Inc. September 2010 - August 2011
Boston Biomedical Associates February 2010 - June 2010
Syndax Pharmaceuticals, Inc. September 2009 - December 2009
Veristat August 2008 - August 2009
PROMETRIKA January 2008 - May 2008
Skills
EDC, CRF design, Oracle Clinical, Clinical Data Management, Clinical Trials, GCP, CTMS, ICH-GCP, Oncology, CRO, CDISC, Inform, MedDRA, Clinical Development, Clinical Monitoring, Clinical Data, Medidata
Education
Quinsigamond Community College 2010 — 2010
RN, Nursing
Broward College 1995 — 1995
Paramedic
SignalQuest, Inc. February 2010 - Present
TransMedics, Inc. May 2005 - March 2010
Medtronic, Inc October 2002 - May 2005
Vasca Inc. June 1998 - October 2002
Teradyne October 1997 - June 1998
Haemonetics July 1994 - October 1997
Education
University of Massachusetts Lowell 1990 — 1994
BS, Industrial Technology
Endicott College 2007 — 2009
MBA
Edwards Lifesciences March 2015 - Present
Medtronic Orange County February 2009 - March 2015
TransMedics, Inc. June 2006 - February 2009
Atrium Medical October 2003 - June 2006
Smith and Nephew Endoscopy March 2000 - September 2003
University of Massachusetts Lowell June 2000 - May 2002
Symmetry Medical October 1993 - March 2000
Skills
Design Control, ISO 13485, Medical Devices, FDA, V&V, Design of Experiments, Injection Molding, Design for Manufacturing, CAPA, ISO 14971, Quality System, Minitab, Biomedical Engineering, Validation, Manufacturing..., FMEA, Six Sigma, SPC, DMAIC, Plastics, R&D, Manufacturing
Education
Brandman University, Part of the Chapman University System 2012 — 2015
Master of Business Administration (M.B.A.), Organizational Leadership & Development
University of Massachusetts at Lowell 2000 — 2004
Master's Degree, Plastics Engineering
University of Massachusetts at Lowell 1994 — 2000
Bachelor's Degree, Plastics Engineering
Sirtex Technology September 2008 - Present
TransMedics, Inc. May 2007 - September 2008
Thoratec Corporation 1996 - 2007
Insulet Corporation 2004 - 2004
Polymer Technology Corporation 1985 - 1996
Skills
Medical Devices, Clinical Research, Clinical Trials, Oncology, GCP, FDA, Biotechnology, Healthcare
Education
Rivier College 1991 — 1996
M.B.A.
Rivier College 1981 — 1985
B.S., Biology
Philips Healthcare December 2014 - Present
Philips Healthcare January 2012 - November 2014
Philips Healthcare July 2010 - December 2011
Philips Healthcare 2008 - September 2010
TransMedics, Inc. April 2007 - July 2008
Cytyc May 2005 - April 2007
Cytyc April 2001 - April 2005
PriceWaterhouseCoopers September 1996 - April 2001
Skills
Healthcare, Business Strategy, Sarbanes-Oxley Act, Finance, Cross-functional Team..., Medical Devices, Forecasting
Education
Boston College 1992 — 1996
Bachelor of Science (BS), Accounting
Corvia Medical,Inc. (formerly DC Devices, Inc.) November 2013 - Present
Satori Pharmaceuticals, Inc. 2009 - 2013
TransMedics, Inc. 2004 - 2009
Boston Children's Hospital 1998 - 2003
Boston Children's Hospital 1991 - 1998
Skills
Biotechnology, Pharmaceutical Industry, GMP, Office Management, Start-ups, Benefits Administration, Accounts Payable, Office Administration, IT Management, Facilities Management, Event Planning, Administrative..., Project Management, Microsoft Office, Administration, Administrative...
Education
Tufts University 1986 — 1991
BA, Political Science and Government
Inventiv Heath January 2015 - Present
Allergan Medical June 2012 - December 2014
TransMedics, Inc. April 2010 - June 2012
Spaulding Rehabilitation Hospital , Boston March 2008 - June 2010
Children's Hospital Boston May 2007 - September 2007
Obstetrics And Gynecology Office December 2002 - August 2007
Skills
Biochemistry, Medical Writing, Medical Devices, Pharmaceutical Industry, Healthcare, Clinical Monitoring, Biotechnology, Clinical Trials, CRO, Molecular Biology, Surgery, Lifesciences, Clinical Research, GCP
Education
University of Massachusetts 2005 — 2007
MS, Clinical laboratory science
University of Medicine Algiers ( Laperine) 1990 — 1998
MD, General Medicine
University of California, San Francisco
Certification, Clinical Psychology of Children and Young People
University of California, San Francisco
Coursera, Diabetes challenge
Pamela Goldstein QA March 2013 - Present
GI Dynamics 2007 - April 2014
TransMedics, Inc. 2005 - 2007
MediSpectra 2000 - 2005
Medtronic 1996 - 2000
C. R. Bard 1991 - 1996
Education
Worcester Polytechnic Institute 1989 — 1991
MS, Biomedical Engineering
University of Massachusetts, Amherst 1982 — 1986
BS, Electrical Engineering
TransMedics, Inc. Mechanical Design EngineerGilletteJune 1999 - May 2001
Skills
Design Control, Medical Devices, Testing, Mechanical Engineering, Product Development, ISO 13485, Design for Manufacturing, FDA, Engineering
Education
Tufts University 1995 — 1999
BSME
TransMedics, Inc. December 2010 - Present
Aspect Medical Systems, Inc. September 2000 - July 2010
Grant Thornton LLP August 1996 - September 2000
Education
Stonehill College 1992 — 1996
NeuroLogica October 2013 - Present
ITT Corporation June 2012 - October 2012
ITT Corporation October 2010 - July 2011
Morgan Constructioin March 2005 - August 2007
Summit Technical Services 2000 - 2007
TransMedics, Inc. 2001 - 2005
TransMedics, Inc. 2001 - 2005
TransMedics, Inc. 2001 - 2005
Sturtevant Inc. August 1985 - June 1999
Skills
Solid Modeling, Sheet Metal, Pro/Engineer, Solidworks, Manufacturing, GD&T, Mechanical Engineering, Catia, CAD, PDM, Engineering, Manufacturing..., AutoCAD Mechanical, Product Design, Product Development, AutoCAD, Aerospace, Design for Manufacturing, Machine Design, Unigraphics, Finite Element Analysis, Design Engineering, Modeling, ANSYS, Pro Engineer, Windchill, Tolerance Analysis, Testing, R&D, Machine Tools, Engineering Management, Lean Manufacturing, Machining, SolidWorks, PTC Creo
Education
Wentworth Institute of Technology 1997 — 2004
Bachelor's degree, Mechanical Engineering
Wentworth Institute of Technology 1983 — 2004
Bachelor of Applied Science (B.A.Sc.), Mechanical Engineering
Northeastern University 1982 — 2000
CERTIFICATE, engineering/cad
Philips April 2015 - Present
Philips January 2013 - April 2015
NxStage Medical May 2009 - December 2012
TransMedics, Inc. July 2006 - May 2009
Medtronic Vascular July 2000 - July 2006
Medtronic 2000 - 2006
Education
Suffolk University - Sawyer Business School 2006 — 2009
Masters, Accounting Focus
Merrimack College 1995 — 2000
BS, Finance & Business Management
TransMedics, Inc. 2011 - Present
Medical Device Consultants Inc. 2008 - 2011
Haemonetics Corporation 1998 - 2008
Dade Behring Inc. 1992 - 1998
Skills
FDA, ISO 13485, Biotechnology, Lifesciences, Clinical Development, Design Control, GCP, Oncology, CAPA, Regulatory Affairs, Regulatory Submissions, Cardiology, CTMS, Validation, Sop, Life Sciences, SOP
Education
University of Rhode Island 1996 — 2000
M.Sci., Clinical Laboratory Science
Mount Holyoke College 1976 — 1980
BA, Biochemistry
TransMedics, Inc. January 2015 - Present
Boston Scientific April 2011 - December 2014
Acceleron August 2008 - March 2011
Boston Scientific June 2007 - July 2008
Point Therapeutics May 2005 - May 2007
Perceptive March 2004 - May 2005
Education
Northeastern University 2000 — 2002
MS, Clinical Exercise Physiology
University of Massachusetts Lowell 1996 — 2000
B.S, Exercise Physiology
Hologic, Inc. February 2014 - Present
TransMedics, Inc. September 2012 - November 2013
Premier Research Group January 2012 - September 2012
Premier Research July 2010 - January 2012
Westfield State University January 2007 - May 2010
SRBI April 2009 - March 2010
Skills
Oracle Clinical, Clinical Data Management, Data Analysis, CRF design, Project Management, Data Management, Clinical Trials, Rave, Clinical Study Design, Databases, CDISC, Validation, Sop, Clinical Research, Software Documentation, CRO, SOP
Education
Southern New Hampshire University 2012 — 2014
Master of Business Administration (MBA), Business Administration and Management, General
Westfield State College 2006 — 2010
Bachelor's Degree Dual Major, Computer Information Systems and Business Management
TransMedics, Inc. July 2000 - Present
West Roxbury VA Medical Center July 1995 - June 1998
Georgetown University Medical Center June 1993 - June 1995
Skills
Medical Devices, Clinical Trials, Biotechnology, FDA, Cardiology, Clinical Research, Surgery, Biomedical Engineering, Commercialization, ISO 13485, Lifesciences, Research
Education
Georgetown University School of Medicine 1990 — 1993
MD, Medicine
Atlantic Tele-Network, Inc. October 2014 - Present
TransMedics, Inc. 2010 - May 2014
Aspect Medical Systems 2004 - 2010
Cambrex 2002 - 2003
UroMed 1996 - 2002
Education
Boston University 1994 — 1997
MBA, Finance
Northeastern University 1982 — 1987
Business, Accounting
NxStage Medical October 2009 - Present
TransMedics, Inc. October 2004 - October 2009
Deka Research 2001 - 2004
Siemens Medical 1986 - 2001
Preferred Electronics 1983 - 1986
Education
Northeastern University 1998 — 2003
MSEE, Controls and Signal Processing
University of Massachusetts Lowell 1972 — 1976
BSEE
Ivenix, Inc. November 2011 - Present
Transmedics, Inc. August 2010 - November 2011
Haemonetics Corp. March 2001 - August 2010
Transfusion Technologies (acquired by Haemonetics) 1995 - 2000
PSI Medical Products 1990 - 1995
Smith and Nephew 1980 - 1990
Skills
Clinical Research, Medical Devices, Clinical Trials, Design Control, FDA, Regulatory Affairs, Product Development, ISO 13485, CAPA, Quality System, Product Launch
Education
Boston College 1975 — 1977
MS, Biology
Fairfield University 1970 — 1974
BS, Biology
TransMedics, Inc. Laboratory ManagerToxikon CorporationMarch 1987 - November 2004
Skills
GMP, Clinical Research, Biotechnology, Product Development, R&D, Oncology, ISO 13485, Medical Devices, CRO, GLP, Clinical Data Management, GCP, Design Control, FDA, EDC, Clinical Development, Clinical Trials, Validation, Biomedical Engineering, Pharmaceutical Industry, Sop, Lifesciences, Six Sigma, Cross-functional Team..., Healthcare, CTMS, V&V
Education
Colby College 1979 — 1983
BA, Biology
TransMedics, Inc. November 2011 - Present
Haemonetics May 2011 - October 2011
Medical Device Consultants, Inc February 2009 - October 2010
Keystone Dental November 2007 - December 2008
Pleiad Devices May 2006 - November 2007
Matritech, Inc November 2003 - May 2006
Matritech, Inc March 2001 - November 2003
This End Up Furniture Co., Inc. 1989 - 2000
Memorial Sloan-Kettering Cancer Center April 1975 - August 1982
Skills
Medical Devices, Heart Transplant, Clinical Trials, Lung Transplantation, Lifesciences, Oncology, IVD, Biotechnology, FDA, Clinical Development, CTMS, EDC, ISO 13485, Clinical Data Management, Clinical Research, GCP, CRO, Cardiology, Regulatory Submissions, Regulatory Affairs
Education
College of Mount Saint Vincent 1970 — 1975
BS, Biology
Manhattan College 1970 — 1975
BS, Biology
TransMedics, Inc. December 2013 - Present
Valeritas March 2013 - October 2013
DEKA Research & Development February 2005 - March 2013
Agfa September 1995 - January 2005
Wang Labs 1984 - 1990
Wang Labs 1984 - 1990
Wang Labs 1984 - 1990
Skills
Lean Manufacturing, Six Sigma, Sheet Metal, Mechanical Engineering, Continuous Improvement, Process Improvement, Design for Manufacturing, ISO, Plastics, Manufacturing...
Education
University of Massachusetts at Lowell 1977 — 1984
Bachelor of Applied Science (B.A.Sc.), Mechanical Engineering
Wentworth Institute of Technology 1966 — 1968
Associate of Science (AS), Aerospace, Aeronautical and Astronautical Engineering
OvaScience September 2014 - Present
TransMedics, Inc. August 2013 - August 2014
Lantheus Medical Imaging August 2008 - August 2013
Lantheus Medical Imaging July 2010 - December 2010
Critical Therapeutics 2005 - 2008
PerkinElmer 2003 - 2005
PwC 1998 - 2002
Coopers & Lybrand, LLP 1996 - 1998
Education
Georgetown University 1992 — 1996
Belmont Hill School 1985 — 1991
St. Jude Medical February 2011 - Present
Trachtenberg Legal Consulting September 2009 - February 2011
TransMedics, Inc. 2004 - 2009
Hamilton, Brook, Smith & Reynolds, P.C. 1997 - 2003
Skills
Patents, Intellectual Property, Medical Devices, Patent Litigation, Patent Prosecution, Trade Secrets, Trademarks, Licensing, FDA, Copyright Law, Client Counseling, Litigation, Biotechnology, Patentability, Trademark Infringement, Due Diligence, Lifesciences, Prosecution, Biomedical Engineering, Registered Patent..., Civil Litigation, Patent Applications, Mergers & Acquisitions
Education
Boston College Law School 1995 — 1998
JD, Law
Duke University 1991 — 1995
BSE, Biomedical Engineering
Northeast Rehabilitation Hospital Network July 2011 - Present
University of New England January 2011 - Present
Portsmouth Regional Hospital July 2007 - Present
Portsmouth Regional Hospital May 2010 - May 2015
STRP July 2006 - June 2007
STRP (Scranton Temple Residency Program) July 2003 - June 2006
TransMedics, Inc. January 2000 - May 2003
Egyptian Army May 1995 - March 1997
Kasr AlAiny School of Medicine, Cairo University March 1994 - March 1995
Skills
Healthcare, Hospitals, Healthcare Management, Medicine, Medical Education, Healthcare Information..., Internal Medicine, Clinical Research, Patient Safety, EMR, Physicians, Board Certified, Inpatient
Education
Cairo University 1986 — 1993
Bachelor of Medicine, Bachelor of Surgery (M.B.B.S.), Medicine
American board of Internal Medicine
IM board certification 2007, Internal medicine
TransMedics, Inc. July 2013 - Present
Stryker July 2012 - July 2013
Merck July 2009 - July 2012
Siemens Healthcare July 2008 - August 2008
BD June 2007 - August 2007
Skills
Manufacturing, cGMP, GMP, Process Quality..., Quality Improvement..., Quality Process..., Pharmaceutical Industry, Biomedical Engineering, Lean Manufacturing, Six Sigma, Kaizen, Medical Devices, Product Quality, Continuous Improvement, Root Cause Analysis, Process Improvement, ISO 13485, MS Excel Pivot Tables, FDA, Quality System, Validation, R&D, CAPA
Education
Rensselaer Polytechnic Institute 2005 — 2009
B.S, Biomedical Engineering
Helen of Troy February 2012 - Present
Theorem Clinical Research June 2011 - February 2012
TransMedics, Inc. May 2010 - June 2011
research fellow March 2005 - May 2010
Education
University of Cambridge 2001 — 2005
Doctor of Philosophy (Ph.D.), Pharmacology
Shenyang Medical College 1992 — 1998
Doctor of Medicine (M.D.), clinical medicine
Karyopharm Therapeutics Inc. March 2015 - Present
Abiomed September 2014 - March 2015
TransMedics, Inc. October 2012 - September 2014
Covidien 2008 - 2012
Johnson & Johnson Regenerative Therpeutics September 2005 - April 2008
Alkermes 1999 - 2002
Skills
Biotechnology, FDA, Medical Devices, Pharmaceutical Industry, CTMS, Clinical Trials, Clinical Research
Education
Stonehill College 1995 — 1999
Bachelor of Science (B.S.), Biology, General