GI Dynamics

Industry: Company

Description

Headquarters: Boston, MA Founded: 2003

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GI Dynamics Employees

Employee
Years
Job
Industry
Luke Mertins Luke Mertins Greater Boston Area Details
Luke Mertins's GI Dynamics Experience May 2014 - August 2014
Job Engineering Intern at GI Dynamics
Industry Biotechnology
Experience
GI Dynamics   May 2014 - August 2014
Hemedex, Inc.   May 2013 - August 2013
Sanford Contracting Inc.   February 2009 - February 2011

Skills
Design of Experiements..., Engineering Quality..., Statistical Data..., Mechanical Testing Of..., Technical Writing, Technical..., Matlab, Biological Signal..., Biomedical Engineering, English, Microsoft Word, Microsoft Excel, Windows, PowerPoint

Education
Boston University   2011 — 2015
Bachelor's Degree, Bioengineering and Biomedical Engineering, senior

Gwendolyn Luke Gwendolyn Luke Greater Boston Area Details
Gwendolyn Luke's GI Dynamics Experience 2009 - 2011
Job Mechanical/Robotics R&D Engineer
Industry Mechanical or Industrial Engineering
Experience
SPIROL International  July 2014 - December 2014
DEKA Research & Development  August 2013 - July 2014
Amazing Thinz   July 2011 - October 2011
GI Dynamics   2009 - 2011

Skills
Testing, AutoCAD, Solidworks, Multitasking Skills, Music, General Awesomeness, Proficient Typing Skills, Microsoft Excel, PowerPoint, Paint, Pspice, ANSYS, COMSOL, Robotics, Mechanical Engineering

Education
Worcester Polytechnic Institute   2011 — 2013
Masters, Robotics Engineering

Roger Williams University   2007 — 2011
BS, Mechanical Engineering

Anthony Visone Anthony Visone Greater Boston Area Details
Anthony Visone's GI Dynamics Experience November 2011 - August 2015
Job Manufacturing Enginner at GI Dynamics
Industry Mechanical or Industrial Engineering
Experience
GI Dynamics   November 2011 - August 2015
STAVROS HEALTH CARE AGENCY   January 2009 - November 2011
IBM  June 2008 - September 2008

Skills
AutoCAD, Automotive, Hands-on Technical, brainstorming, Negotiation, Lease Negotiations, Microsoft Excel, Matlab, Engineering, Manufacturing, Time Management, PowerPoint, Solidworks, Microsoft Office, Research

Education
University of New Hampshire   2011 — 2012
Masters, Business Administration

University of New Hampshire   2007 — 2011
Bachelors of Science, Mechanical Engineering

Andres Chamorro Andres Chamorro Greater Boston Area Details
Andres Chamorro's GI Dynamics Experience February 2012 - November 2014
Job R&D
Industry Medical Devices
Experience
Consulting  December 2014 - Present
Cape Cod Bait & Tackle, LLC   March 2011 - Present
GI Dynamics   February 2012 - November 2014
Cambridge Endoscopic Devices, Inc.   August 2008 - January 2012
Cambridge Endoscopic Devices Inc.   August 2004 - January 2012
GI Dynamics   December 2003 - July 2004
EndoVia Medical   June 2000 - November 2003
Act Medical  1999 - 2000

Skills
Medical Devices, Product Development, R&D, Biomedical Engineering, Solidworks, CAD, Pro/Engineer, Product Design, Design Control, Manufacturing, Design for Manufacturing, Product Launch, Cross-functional Team..., Engineering, V, FDA, Quality System, ISO 13485, PTC Pro/Engineer, SolidWorks

Education
Northeastern University   1998 — 2003

Lindsay Brayton Lindsay Brayton Greater Boston Area Details
Lindsay Brayton's GI Dynamics Experience September 2014 - Present
Job Clinical Trial Associate at GI Dynamics
Industry Medical Devices
Experience
GI Dynamics   September 2014 - Present
Premier Research Group  June 2012 - August 2014
Corindus Vascular Robotics  July 2011 - June 2012
South County Child and Family Consultants  August 2010 - June 2011

Skills
Medical Devices, FDA, Clinical Trials, Clinical Research, CRO, Regulatory Affairs, Therapeutic Areas, IRB, Project Management, CTMS, Clinical Development, EDC, GCP, Clinical Data Management, Clinical Monitoring, Oracle Clinical

Education
University of Rhode Island   2007 — 2011
Bachelor of Arts (BA)

Susan Latiff - Dalrymple Susan Latiff - Dalrymple Greater Boston Area Details
Susan Latiff - Dalrymple's GI Dynamics Experience July 2012 - July 2014
Job Graduate Student at Northeastern University
Industry Pharmaceuticals
Experience
Northeastern University  September 2014 - Present
GI Dynamics   July 2012 - July 2014
PAREXEL  June 2011 - June 2012
PAREXEL  November 2008 - June 2011
PAREXEL  September 2006 - November 2008
Dynamics Research  June 2002 - September 2006
Suffolk University  January 1999 - May 2002

Skills
Project Management, GCP, CRO, CTMS, Clinical Trials, EDC, Revenue Recognition, Planning Budgeting &..., Clinical Research, Microsoft Excel, Medical Devices, Project Planning, Clinical Site Management, Clinical Development, ICH-GCP, Oncology, Clinical Operations, Oracle Clinical, Pharmaceutical Industry

Education
Northeastern University   2014 — 2019
Doctor of Philosophy (PhD), Psychology (Cognition)

Suffolk University   1999 — 2002
BS, Psychology

Jonathan Hartmann Jonathan Hartmann Greater Boston Area Details
Jonathan Hartmann's GI Dynamics Experience April 2007 - June 2010
Job General Manager at Philips Healthcare, Axsun Techologies
Industry Medical Devices
Experience
Philips Healthcare, Axsun Techologies   December 2013 - Present
Volcano Corporation  August 2010 - Present
GI Dynamics   April 2007 - June 2010
Cyberkinetics   2006 - 2007
Guidant  2000 - 2006
Urologix  1997 - 1998
W.L. Gore & Associates   1994 - 1997
US Surgical  1992 - 1994
Xerox Corporation  1988 - 1992

Skills
General Management, Leadership, Strategy and Execution

Education
Harvard Business School
MBA, General Management

Saint Lawrence University
BS, Pre-Med

Kristi (Yuszkus) Dacey Kristi (Yuszkus) Dacey Greater Boston Area Details
Kristi (Yuszkus) Dacey's GI Dynamics Experience January 2013 - December 2014
Job Quality Engineer at Philips Healthcare
Industry Medical Devices
Experience
Philips Healthcare  December 2014 - Present
GI Dynamics   January 2013 - December 2014
GI Dynamics   January 2012 - December 2014
GI Dynamics   September 2010 - December 2011
GI Dynamics   June 2008 - September 2010
Albright College  September 2006 - May 2009

Skills
Medical Devices, Quality Assurance, Validation, CAPA, Design Control, MRI, R&D, PowerPoint, Technical Files, Project Management, Lifesciences, Quality System, Life Sciences, Writing, Regulatory Submissions, Regulatory Compliance, Project Planning, Internal Audit, External Audit, Quality Auditing, Medical Device Directive, Metrics, Biotechnology, ISO 13485, FDA, Sop

Education
Boston University School of Medicine   2009 — 2010
M.A., Bioimaging

Albright College   2005 — 2009
B.S., Biology/Biotechnology

Kimberly Hoffman Kimberly Hoffman Greater Boston Area Details
Kimberly Hoffman's GI Dynamics Experience September 2014 - August 2015
Job Principal at Sandy Pond GCP, LLC
Industry Medical Devices
Experience
Sandy Pond GCP, LLC   September 2015 - Present
GI Dynamics   September 2014 - August 2015
Shire Pharmaceuticals  April 2014 - August 2014
Avedro, Inc.   October 2012 - April 2014
Boston Scientific  August 2011 - October 2012
Boston Scientific  April 2009 - August 2011
Synta Pharmaceuticals  September 2007 - March 2009
Bristol Myers Squibb Medical Imaging  2005 - 2007
Alkermes  2003 - 2005
Gilson  2002 - 2002

Skills
FDA, Clinical Development, CAPA, Clinical Trials, 21 CFR Part 11, Quality Assurance, Validation, GCP, Pharmaceutical Industry, GMP, CRO, Regulatory Submissions, Quality System, Sop, Regulatory Affairs, Biotechnology, Medical Devices, Change Control, ISO 13485, EDC, Lifesciences, Protocol, Quality Control, Clinical Research, LIMS, GLP, Cross-functional Team..., Computer System..., GxP, Life Sciences, SOP

Education
University of Delaware   1998 — 2000
M.S

Simmons College   1994 — 1995
M.A.

University of Delaware   1989 — 1992
BA

Randy Koester Randy Koester Greater Boston Area Details
Randy Koester's GI Dynamics Experience June 2014 - December 2014
Job Device & Combination Product QMS Remediation Consultant
Industry Medical Devices
Experience
Shire  March 2015 - Present
GI Dynamics   June 2014 - December 2014
Covidien  October 2007 - June 2014
Covidien  April 2006 - October 2007
Covidien  November 2004 - April 2006
Covidien  January 2002 - November 2004
Rexam Release  September 1997 - February 2000

Skills
FDA, Quality System, Process Improvement, Quality Auditing, GMP, Medical Devices, Quality Control, Six Sigma, Root Cause Analysis, Manufacturing, ISO 13485, Quality Assurance, Lean Manufacturing, CAPA, Cross-functional Team..., Regulatory Affairs, Validation, DMAIC, ISO 14971, R&D, ISO, SPC, FDA GMP, Pharmaceutical Industry, Minitab, Design Control, Quality Management, V&V

Education
University at Buffalo   1991 — 1995
BACHELOR OF SCIENCE, Chemical Engineering

Kelly Woessner Kelly Woessner Lexington, Massachusetts Details
Kelly Woessner's GI Dynamics Experience December 2014 - Present
Job Clinical Trial Associate at GI Dynamics
Industry Medical Devices
Experience
GI Dynamics   December 2014 - Present
GI Dynamics   December 2013 - December 2014
Array BioPharma Inc.  September 2005 - November 2011

Skills
Biotechnology, FDA, Medical Devices, Clinical Trials, Life Sciences, Validation, Pharmaceutical Industry, Clinical Development, Oncology, GCP, SOP, Regulatory Affairs

Education
University of Illinois at Urbana-Champaign   1983 — 1987
MS, Biochemistry

Hiram College   1979 — 1983
Bachelor of Arts (B.A.), Chemistry, ACS accredited

Kyle Russo Kyle Russo Greater Boston Area Details
Kyle Russo's GI Dynamics Experience May 2012 - August 2013
Job Senior Associate Professional Development Program
Industry Financial Services
Experience
State Street  June 2015 - Present
The Ezra Company  February 2015 - May 2015
State Street  June 2014 - February 2015
Parella   February 2014 - June 2014
GI Dynamics   May 2012 - August 2013
George Washington University Program Board  May 2012 - May 2013
Apartment Depot   June 2011 - September 2012
Teach for America  December 2011 - May 2012

Skills
Microsoft Office, Nonprofits, Recruiting, Strategic Planning, PowerPoint, Social Media, Marketing, Microsoft Excel, Leadership, Fundraising, Project Management, Data Analysis, Research, Finance, Corporate Finance, Market Research, Management Consulting, Public Speaking, Event Planning, Microsoft Word

Education
The George Washington University   2011 — 2015
Bachelor of Science (BS), Economics

Newton South High School

Jamie S. Blose, Pharm.D., MBA Jamie S. Blose, Pharm.D., MBA San Diego, California Details
Jamie S. Blose, Pharm.D., MBA's GI Dynamics Experience 2013 - 2015
Job Drug Development & Business Executive
Industry Pharmaceuticals
Experience
NovaQuest - Consultant   April 2008 - April 2015
GI Dynamics   2013 - 2015
HUYA Bioscience International  October 2013 - July 2014
Tethys Bioscience, Inc.   October 2012 - September 2013
Elcelyx Therapeutics Inc.   January 2010 - September 2011
Amylin Pharmaceuticals  2001 - 2007
Quintiles  1995 - 2001
GlaxoSmithKline  1993 - 1995

Education
University of San Diego School of Law
Juris Doctor Candidate, International and Corporate Law

University of North Carolina at Chapel Hill   1993 — 1995
Post-Doctoral Fellowship, Drug Development/Clinical Research

Thunderbird School of Global Management   1991 — 1993
International MBA

University of Arizona   1987 — 1991
Doctor of Pharmacy, Pharm.D

Katy Bonnin Katy Bonnin Greater Boston Area Details
Katy Bonnin's GI Dynamics Experience January 2015 - July 2015
Job Director of Marketing at BionX
Industry Medical Devices
Experience
BionX Medical Technologies   August 2015 - Present
GI Dynamics   January 2015 - July 2015
GI Dynamics   January 2013 - January 2015
Sanofi  March 2010 - December 2012
Genzyme  September 2007 - March 2010
Genzyme  March 2004 - September 2007
Scleroderma Foundation  May 2002 - March 2004
Simmons College  November 2000 - May 2002
Head of the Charles Regatta  March 1999 - November 2000

Skills
Marketing Strategy, Product Launch, Medical Devices, Cross-functional Team..., Biotechnology, Patient Education, Competitive Analysis, Market Research, Global Marketing, Brand Management, Neurology, Marketing, Patient Advocacy, Prosthetics, Pharmaceutical Industry, Product Marketing, Commercialization, Event Management, Lifesciences, Marketing Communications, Medical Affairs, Oncology, Nephrology, CRM, Endocrinology, Type 2 Diabetes, Orphan Drugs, Customer Insight, Obesity, Brand Development, Online Marketing, Strategy

Education
University of California, Santa Barbara   1985 — 1990
Bachelor of Arts (B.A.)

California Western School of Law   1990 — 1992
Juris Doctorate

Brendan Wrigley Brendan Wrigley Greater Boston Area Details
Brendan Wrigley's GI Dynamics Experience May 2015 - September 2015
Job Clinical Trial Manager at Karyopharm Therapeutics
Industry Pharmaceuticals
Experience
Karyopharm Therapeutics Inc.  August 2015 - Present
GI Dynamics   May 2015 - September 2015
GI Dynamics   September 2014 - May 2015
Dana-Farber Cancer Institute  September 2012 - August 2014
Clinical Assistance Programs  August 2011 - September 2012
Veristat, Inc.   March 2010 - August 2011
Hasbro  June 2008 - December 2008

Skills
Pharmaceutical Industry, Oncology, Microsoft Office, Clinical Research, Sop, Biotechnology, PowerPoint, Access, Training, Microsoft Excel, Clinical Trials, Medical Devices, GCP, CTMS, Clinical Development

Education
Bryant University   2007 — 2008
Masters, Business Administration

University of Massachusetts, Amherst   2003 — 2007
Bachelor of Science, Biology

Danielle Lussier Danielle Lussier Westford, Massachusetts Details
Danielle Lussier's GI Dynamics Experience February 2014 - Present
Job Realtor
Industry Real Estate
Experience
Picket Fence Properties LLC   April 2015 - Present
GI Dynamics   February 2014 - Present
Qualtré Inc.   August 2013 - November 2013
QinetiQ North America  August 2008 - October 2012
OmniSonics Medical Technologies  March 2007 - August 2008
Abercrombie & Fitch  October 2005 - January 2007

Skills
Time Management, Administrative..., Data Entry, Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Customer Service, Outlook, Sales, Event Planning, Marketing, Social Media, Administration, Filing, Telephone Skills

Education
American Real Estate Academy   2015 — 2015
Real Estate Salesperson, Real Estate

Fitchburg State College   2005 — 2009
Criminal Justice and Corrections

DrinkMaster Bartending School   2008 — 2008
Bartending/Bartender

Kayla Ngan Kayla Ngan Boston, Massachusetts Details
Kayla Ngan's GI Dynamics Experience June 2011 - August 2011
Job Analyst at Analysis Group
Industry Management Consulting
Experience
Analysis Group  September 2015 - Present
Check Point Software Technologies, Ltd.   June 2015 - August 2015
Brigham and Women's Hospital  January 2015 - May 2015
Analysis Group  June 2014 - August 2014
Charles River Associates  January 2014 - January 2014
EMD Millipore  May 2013 - August 2013
MIT  March 2012 - February 2013
MIT  February 2012 - September 2012
GI Dynamics   June 2011 - August 2011

Skills
Research, Microsoft Excel, Teaching, Matlab, Management, Microsoft Word, SAS, Data Analysis, Market Research, Accounting, Stata, Python, Java, Business Objects, Salesforce.com, LaTeX, HTML, CSS, Analysis, VBA, Django, Linux, Git

Education
MIT   2011 — 2015
Bachelor of Science (B.S.), Chemical Engineering and Management Science

Lincoln-Sudbury Regional High School   2007 — 2011

Brittany Melanson Brittany Melanson Lexington, Massachusetts Details
Brittany Melanson's GI Dynamics Experience December 2012 - Present
Job Marketing Specialist at GI Dynamics
Industry Medical Devices
Experience
GI Dynamics   December 2012 - Present
Do Can Brewery   September 2013 - January 2015
GI Dynamics   January 2009 - December 2012
WUML, Lowell Radio  2009 - 2012
Sylvan Learning Centers  September 2010 - September 2011

Skills
Event Planning, Time Management, Social Media, Customer Service, Microsoft Office, Medical Devices, Leadership, Management, Market Research, Microsoft Excel, International Event..., PowerPoint, Social Networking, Microsoft Word, Sales, Advertising, Project Management, Product Launch, Marketing, Marketing Strategy, Customer Relations, Key Opinion Leaders

Education
University of Massachusetts Lowell   2008 — 2012
Bachelor of Business Administration (BBA), Marketing

Rahul Chaturvedi Rahul Chaturvedi Greater Boston Area Details
Rahul Chaturvedi's GI Dynamics Experience April 2014 - Present
Job VicePresident, Clinical Development at GI Dynamics
Industry Pharmaceuticals
Experience
GI Dynamics   April 2014 - Present
Avedro, Inc.   June 2010 - March 2014
Avedro, Inc.   March 2010 - June 2010
Cetero Research  September 2009 - March 2010
ORA Clinical Research & Development   February 2008 - September 2009
ORA Clinical Research & Development   August 2005 - January 2008

Skills
Clinical Trials, Pharmaceutical Industry, FDA, Start-ups, Entrepreneurship, Medical Devices, Strategic Planning, Clinical Research, Cross-functional Team..., Drug Development, Clinical Development, CTMS, IND, R&D, Data Management, Protocol, Due Diligence, International..., Strategic Alliances, Business Strategy, Biotechnology, Life Sciences

Education
Brandeis University
Bachelor of Science, Biology

Jean-Claude Tetreault Jean-Claude Tetreault Greater Boston Area Details
Jean-Claude Tetreault's GI Dynamics Experience May 2008 - Present
Job Director, Post Marketing Research at GI Dynamics
Industry Medical Devices
Experience
GI Dynamics   May 2008 - Present
Millennium Pharmaceuticals, Inc.   August 2001 - April 2008
Millennium Pharmaceuticals, The Takeda Oncology Company  2003 - 2008
Beth Israel Deaconess Medical Center  1999 - 2001

Skills
Lifesciences, Biotechnology, Clinical Trials, Medical Affairs, Clinical Development, Management, GCP, Validation, CRO, FDA, Oncology, Medical Devices, Clinical Research, Product Launch, Leadership, Program Management

Education
Sacred Heart University   1994 — 1998
BS, Biology/Biochemistry

Jennifer Cormier Jennifer Cormier Greater Boston Area Details
Jennifer Cormier's GI Dynamics Experience February 2014 - October 2014
Job Senior Clinical Project Manager at Acorda Therapeutics, Inc.
Industry Biotechnology
Experience
Acorda Therapeutics, Inc.   October 2014 - Present
GI Dynamics   February 2014 - October 2014
GI Dynamics   August 2010 - February 2014
Shire  September 2008 - August 2010
Intercytex   May 2008 - September 2008
Rhytec, Inc   February 2007 - April 2008
Parexel  2006 - 2007
Lahey Clinic  2002 - 2006

Skills
Medical Devices, Clinical Research, Clinical Trials, Life Sciences, CTMS, Lifesciences, Biotechnology, Clinical Development, Cell Biology, FDA, Molecular Biology, CRF design, Protocol, Clinical Monitoring, EDC, GCP, CRO, Clinical Data Management, Validation, Regulatory Submissions

Education
University of Massachusetts Boston   2002 — 2005
BS, Biology

Glenda Maguire Glenda Maguire Greater Boston Area Details
Glenda Maguire's GI Dynamics Experience September 2014 - Present
Job Accounting Manager
Industry Pharmaceuticals
Experience
GI Dynamics   September 2014 - Present
Interactive Data  March 2007 - September 2014
Fresenius Medical Care  August 2003 - March 2007
Lowe Grob Health and Science   May 2002 - August 2003
Charles River Ventures  January 2001 - March 2002
Cypress Tree Investment Management   July 1999 - January 2001

Skills
Financial Reporting, Account Reconciliation, Sarbanes-Oxley Act, Corporate Finance, Internal Controls, Revenue Recognition, Accounting, Financial Analysis, Financial Modeling, US GAAP, Financial Statements, Consolidation, Journal Entries, Microsoft Excel, Financial Accounting

Education
Bentley University   1990 — 1993
BS, International Business

Christopher Nutting Christopher Nutting Greater Boston Area Details
Christopher Nutting's GI Dynamics Experience October 2007 - September 2012
Job Associate Staff
Industry Defense & Space
Experience
MIT Lincoln Laboratory  September 2012 - Present
GI Dynamics   October 2007 - September 2012
Innovative Spinal Technologies  January 2007 - September 2007
Millipore  January 2005 - January 2007
Accellent  February 2003 - January 2005
Boston Scientific  August 1997 - January 2003

Skills
Product Development, R&D, Design of Experiments, Medical Devices, ISO 13485, Design for Manufacturing, Engineering Management, Quality System, Design Control, Validation, Root Cause Analysis, V&V, Biomedical Engineering, FDA, Process Engineering, Aerospace, Systems Engineering, Manufacturing..., Project Management, Space Systems, CAD/CAM, Materials Science, Problem Solving, Metal Fabrication, Test Methodologies, Spacecraft, Polymer Characterization, Injection Molding, Fluoropolymers, System Architecture

Education
Stevens Institute of Technology
Master's Degree, Space Systems Engineering

Northeastern University
Bachelor of Science (BS), Mechanical Engineering

Jennifer Lisauskas Jennifer Lisauskas Greater San Diego Area Details
Jennifer Lisauskas's GI Dynamics Experience May 2012 - September 2013
Job Biomedical Engineer, Medical Devices
Industry Medical Devices
Experience
Volcano Corporation  September 2013 - Present
GI Dynamics   May 2012 - September 2013
LightLab Imaging, St. Jude Medical   December 2010 - May 2012
InfraReDx  April 2010 - November 2010
InfraReDx  March 2005 - April 2010
Massachusetts General Hospital  January 2004 - March 2005
BJC HealthCare  September 1997 - July 2001

Skills
Clinical Research, Regulatory Affairs, Medical Devices, Biomedical Engineering, ISO 13485, FDA, Design Control, Capital Equipment, Medical Imaging, CAPA, R&D, Biotechnology, V&V, Manufacturing, Validation, Product Development

Education
University of Iowa   1995 — 1997
Master of Science (MS), Biomedical Engineering

Worcester Polytechnic Institute   1991 — 1995
Bachelor of Science (BS), Mechanical Engineering

Dave Melanson Dave Melanson Greater Boston Area Details
Dave Melanson's GI Dynamics Experience July 2003 - Present
Job VP Engineering at GI Dynamics
Industry Medical Devices
Experience
GI Dynamics   July 2003 - Present
Boston Scientific  1995 - 1998

Skills
Medical Devices

Education
University of Massachusetts Lowell   1987 — 1992

Loretta Mooney Loretta Mooney Greater Boston Area Details
Loretta Mooney's GI Dynamics Experience April 2015 - August 2015
Job Sr. Manager Quality & Regulatory
Industry Medical Devices
Experience
Philips Healthcare  2011 - Present
GI Dynamics   April 2015 - August 2015
Philips Medical Systems  November 2008 - December 2011
National Biological Corporation  April 2008 - November 2008
National Biological Corporation  April 2008 - November 2008
STERIS Corporation  2007 - 2008
Coltene Whaledent  2003 - 2004
NeuroControl   2000 - 2001
Prizm Medical   1998 - 2000
Medex Medical  1990 - 1997

Skills
FDA, Medical Devices, ISO 13485, Design Control, Quality System, CAPA, Regulatory Affairs, CE marking, ISO 14971, GMP, Biomedical Engineering, Validation, Regulatory Submissions, ISO, Product Development, 21 CFR Part 11, V&V, Manufacturing, Quality Assurance, Root Cause Analysis, Continuous Improvement, Lean Manufacturing, FMEA, Quality Auditing, R&D, Quality Management, Cross-functional Team...

Education
Northeastern University   2009 — 2011
Masters, Regulatory Affairs

Kennesaw State University   1997 — 1999
Bachelor of Science (BS), Biology, General

Barbara DiMento Barbara DiMento Greater Boston Area Details
Barbara DiMento's GI Dynamics Experience January 2015 - Present
Job Lead CRA at GI Dynamics
Industry Research
Experience
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

Leaya Martelli Leaya Martelli Greater Boston Area Details
Leaya Martelli's GI Dynamics Experience November 2014 - May 2015
Job HR Generalist at Comark
Industry Biotechnology
Experience
Comark  June 2015 - Present
Employment Consultant   October 2014 - Present
GI Dynamics   November 2014 - May 2015
Place Boston   March 2006 - October 2014
The Alpha Group  2001 - 2006
Model Select International   1999 - 2001

Skills
Biotechnology, Pharmaceutical Industry, Regulatory Affairs, Clinical Trials, Recruiting, FDA, Medical Devices, Clinical Development, Lifesciences, Biopharmaceuticals, CRO, Regulatory Requirements, EDC

Education
SMSH

SMSH

SMSH

St. Petersburg College
Business Adminstration

Pamela Goldstein Pamela Goldstein Greater Boston Area Details
Pamela Goldstein's GI Dynamics Experience 2007 - April 2014
Job Principal at Medical Device Quality Consulting, LLC
Industry Medical Devices
Experience
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

Francine Lombardi Francine Lombardi Greater Boston Area Details
Francine Lombardi's GI Dynamics Experience August 2014 - Present
Job Contract Clinical Data Manager at GI Dynamics
Industry Biotechnology
Experience
GI Dynamics   August 2014 - Present
GI Dynamics   September 2010 - January 2013
Veristat, Inc.   June 2008 - September 2010
Abt Biopharma Services   November 2004 - June 2008
AAI/MTRA   2001 - 2004

Skills
Clinical Data Management, Oracle Clinical, Clinical Trials, Inform, Clinical Research, CTMS, Medical Devices, Data Management, CRO, GCPs, Regulatory Requirements, Health Advocacy, Clinical Development, MedDRA, Retail, Technical Writing, SAS, GCP

Education
The Sage Colleges - Russell Sage College
BA, Biology/Medical Technology

University of Massachusetts, Amherst
MS, Public Health

Elaine Chiquette Elaine Chiquette Greater Boston Area Details
Elaine Chiquette's GI Dynamics Experience December 2013 - Present
Job VP Medical Affairs at GI Dynamics
Industry Pharmaceuticals
Experience
GI Dynamics   December 2013 - Present
Amylin  May 2009 - July 2013
Amylin Pharmaceuticals  September 2003 - May 2009

Education
The University of Texas at Austin   1994 — 1996
Post Doctorate, Pharmacology

The University of Texas at Austin   1992 — 1994
Doctor of Pharmacy (Pharm.D.)

Université Laval   1988 — 1989
Residency in Hospital Pharmacy

Université Laval   1984 — 1988
Bachelor of Pharmacy (BPharm)

Robert Crane Robert Crane Greater Boston Area Details
Robert Crane's GI Dynamics Experience June 2004 - Present
Job Chief Financial Officer
Industry Medical Devices
Experience
GI Dynamics   June 2004 - Present
MicroCHIPS  2003 - 2010

Skills
Medical Devices, Venture Capital, Corporate Development, Start-ups, Product Development, Commercialization, Lifesciences, Product Launch, R&D, Cross-functional Team..., Market Development, FDA, Biotechnology, Strategy, Technology Transfer, Pharmaceutical Industry, Quality System, Hardware Diagnostics

Education
Stanford University Graduate School of Business   1983 — 1985
MBA, Business

Massachusetts Institute of Technology   1977 — 1981
BS, Mechanical Engineering

Steve Vachon Steve Vachon Greater Boston Area Details
Steve Vachon's GI Dynamics Experience March 2014 - Present
Job Supply Chain Accounting Manager at GI Dynamics
Industry Accounting
Experience
GI Dynamics   March 2014 - Present
SeaChange International  October 2012 - March 2014
SeaChange International  May 2006 - September 2012
Egenera  October 2002 - May 2006
Crescent Networks  2000 - September 2002
Whatman/Balston/Parker Hannifan   1993 - 2000

Skills
Revenue Recognition, Accounting, Forecasting, Fixed Assets, Process Improvement, General Ledger, Hyperion Enterprise, Sarbanes-Oxley Act

Education
Merrimack College
Bachelor of Science (B.S.), Accounting

Sean Holmes Sean Holmes Greater Boston Area Details
Sean Holmes's GI Dynamics Experience January 2014 - Present
Job Senior Clinical Engineer at GI Dynamics
Industry Medical Devices
Experience
GI Dynamics   January 2014 - Present
GI Dynamics   2010 - December 2013
GI Dynamics   2007 - 2010
GI Dynamics   2005 - 2007
Boston Scientific  May 2004 - December 2004
Accellent (previously MedSource)   January 2002 - January 2003
Accellent (previously MedSource)   June 2001 - September 2001

Skills
Product Development, FDA, Validation, Medical Devices, R&D, Solidworks, Product Launch, Commercialization, Testing, Engineering, Biomedical Engineering, Design Control, ISO 13485, V&V, Cross-functional Team..., Biotechnology, CAPA, FMEA, Capital Equipment, Healthcare, Project Management, GMP, Surgical Instruments, Test Methodologies, Manufacturing..., Design for Manufacturing, Work Instructions, Microsoft Office, Medical Device Product..., Medical Device Training, AutoCAD, Medical Device Sales, Cosmos FEA, Good Manufacturing..., Establishing Animal..., Medical Education, Manufacturing, Quality System, Management, Clinical Trials, Market Development, Design of Experiments

Education
Northeastern University   2000 — 2005
Bachelor Of Science, Engineering

Xavier High School   1996 — 2000
High School

Nicholas Cote Nicholas Cote Greater Boston Area Details
Nicholas Cote's GI Dynamics Experience May 2011 - Present
Job Advanced Manufacturing Engineer at GI Dynamics
Industry Mechanical or Industrial Engineering
Experience
GI Dynamics   May 2011 - Present
GI Dynamics   January 2010 - May 2011
Northeastern University  September 2006 - April 2011
Hologic  January 2009 - June 2009
Parker Hannifin  January 2008 - June 2008

Skills
Solidworks, Manufacturing, Finite Element Analysis, R&D, Machining, Testing, FMEA, Quality System, Manufacturing..., Quality Assurance, Lathe, Machine Tools, Microsoft Office, Biomedical Engineering, Medical Devices, V&V, Labview, Materials, Design of Experiments, Matlab, ISO 13485, Pro Engineer, Minitab, FDA

Education
Northeastern University   2006 — 2011
Mechanical Engineering, Biomechanics

Michael Bernatzky Michael Bernatzky Greater New York City Area Details
Michael Bernatzky's GI Dynamics Experience September 2009 - December 2009
Job Mechanical Project Engineer at DÜRR TECHNIK USA, INC.
Industry Mechanical or Industrial Engineering
Experience
DÜRR TECHNIK USA, INC.   July 2012 - Present
Corindus Vascular Robotics  June 2011 - December 2011
Boston Scientific  June 2010 - December 2010
GI Dynamics   September 2009 - December 2009

Skills
Solidworks, ANSYS, Pro Engineer, Design for Manufacturing, R&D

Education
Northeastern University   2007 — 2012
Bachelor's of Science, Mechanical Engineering

Jack Meyer Jack Meyer Greater Minneapolis-St. Paul Area Details
Jack Meyer's GI Dynamics Experience February 2003 - Present
Job Independent Medical Devices Professional
Industry Medical Devices
Experience
Minnetronix, Inc.   September 2005 - Present
GI Dynamics   February 2003 - Present
Medisyn   January 2002 - Present
Urologix  1994 - 1999

Skills
Commercialization, Medical Devices, FDA, Mobile Health, R&D, Design Control

Education
Drake University
MBA

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