Apnex Medical, Inc.
Industry: Company
DescriptionFounded: 2006
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Apnex Medical, Inc. Employees
Employee
Years
Job
Industry
Daniel Parrish Daniel Parrish's Apnex Medical, Inc. Experience 2008 - 2013
Job Intellectual Property Attorney at Brinks Gilson and Lione
Industry Law Practice
Experience
Brinks Gilson and Lione September 2014 - Present
Lawyers' Committee for Better Housing April 2014 - August 2014
OcuTherix January 2014 - August 2014
ClarVista Medical November 2013 - April 2014
Brinks Gilson and Lione May 2013 - August 2013
Apnex Medical, Inc. 2008 - 2013
Westman, Champlin & Koehler, P.A. June 2012 - September 2012
3M May 2007 - May 2008
Mayo Clinic May 2006 - August 2006
Skills
Medical Devices, Matlab, FDA, Biomedical Engineering, Clinical Research, Patent Prosecution, Minitab, SharePoint Designer, R&D, Engineering, Product Development, Data Analysis, Patents, Design Control, Intellectual Property, Clinical Trials, Patent Litigation
Education
William Mitchell College of Law 2010 — 2014
Juris Doctorate, cum laude, 2014., Intellectual Property
University of Minnesota-Twin Cities 2004 — 2008
Bachelor of Science, BioMedical Engineering & Human Physiology (double major)
Brinks Gilson and Lione September 2014 - Present
Lawyers' Committee for Better Housing April 2014 - August 2014
OcuTherix January 2014 - August 2014
ClarVista Medical November 2013 - April 2014
Brinks Gilson and Lione May 2013 - August 2013
Apnex Medical, Inc. 2008 - 2013
Westman, Champlin & Koehler, P.A. June 2012 - September 2012
3M May 2007 - May 2008
Mayo Clinic May 2006 - August 2006
Skills
Medical Devices, Matlab, FDA, Biomedical Engineering, Clinical Research, Patent Prosecution, Minitab, SharePoint Designer, R&D, Engineering, Product Development, Data Analysis, Patents, Design Control, Intellectual Property, Clinical Trials, Patent Litigation
Education
William Mitchell College of Law 2010 — 2014
Juris Doctorate, cum laude, 2014., Intellectual Property
University of Minnesota-Twin Cities 2004 — 2008
Bachelor of Science, BioMedical Engineering & Human Physiology (double major)
Preetinder Bassi Preetinder Bassi's Apnex Medical, Inc. Experience September 2009 - March 2013
Job Clinical Project Manager
Industry Biotechnology
Experience
Torax Medical, Inc. March 2013 - Present
Apnex Medical, Inc. September 2009 - March 2013
New Directions, Inc. December 2007 - June 2011
3M September 2008 - January 2009
University of Minnesota 2005 - 2009
Bermuda Institute of Oceanic Science September 2007 - December 2007
R&D Systems June 2007 - September 2007
Lifeworks Services, Inc. August 2005 - September 2007
Skills
Clinical Research, Medical Devices, Clinical Trials, Lifesciences, Biotechnology, Research, Clinical Data Management, Clinical Data, EDC, R&D, Sop, Protocol, Regulatory Submissions, Clinical Monitoring, Clinical Development, GCP, CTMS, SOP, Life Sciences
Education
University of Minnesota-Twin Cities 2004 — 2009
Bachelor of Science (B.S.), Neuroscience
University of Auckland 2009 — 2009
Harding High School 2000 — 2004
Torax Medical, Inc. March 2013 - Present
Apnex Medical, Inc. September 2009 - March 2013
New Directions, Inc. December 2007 - June 2011
3M September 2008 - January 2009
University of Minnesota 2005 - 2009
Bermuda Institute of Oceanic Science September 2007 - December 2007
R&D Systems June 2007 - September 2007
Lifeworks Services, Inc. August 2005 - September 2007
Skills
Clinical Research, Medical Devices, Clinical Trials, Lifesciences, Biotechnology, Research, Clinical Data Management, Clinical Data, EDC, R&D, Sop, Protocol, Regulatory Submissions, Clinical Monitoring, Clinical Development, GCP, CTMS, SOP, Life Sciences
Education
University of Minnesota-Twin Cities 2004 — 2009
Bachelor of Science (B.S.), Neuroscience
University of Auckland 2009 — 2009
Harding High School 2000 — 2004
Andrea Stone Andrea Stone's Apnex Medical, Inc. Experience September 2012 - February 2013
Job Clinical Program Manager at NxThera
Industry Medical Devices
Experience
NxThera February 2013 - Present
Apnex Medical, Inc. September 2012 - February 2013
Apnex Medical March 2010 - November 2012
Atritech, Inc. January 2005 - March 2010
PPD Medical Device November 2004 - January 2005
Skills
Clinical Data Management, CRF design, EDC, Clinical Trial..., PMA Submission, BIMO Audit Experience, Medical Devices, Inventory Management, CRO, Clinical Trials, FDA, Auditing, GCP, 21 CFR Part 11, Excel, SOP design, Data Analysis, PowerPoint, Word, Database Design, Database Management, People Management, CTMS, Clinical Monitoring, Clinical Research, Clinical Operations, Clinical Development, Database Admin
Education
University of Minnesota-Duluth
NxThera February 2013 - Present
Apnex Medical, Inc. September 2012 - February 2013
Apnex Medical March 2010 - November 2012
Atritech, Inc. January 2005 - March 2010
PPD Medical Device November 2004 - January 2005
Skills
Clinical Data Management, CRF design, EDC, Clinical Trial..., PMA Submission, BIMO Audit Experience, Medical Devices, Inventory Management, CRO, Clinical Trials, FDA, Auditing, GCP, 21 CFR Part 11, Excel, SOP design, Data Analysis, PowerPoint, Word, Database Design, Database Management, People Management, CTMS, Clinical Monitoring, Clinical Research, Clinical Operations, Clinical Development, Database Admin
Education
University of Minnesota-Duluth
Steve Nunley Steve Nunley's Apnex Medical, Inc. Experience August 2011 - March 2013
Job Field Clinical Engineer at Spinal Modulation
Industry Medical Devices
Experience
Spinal Modulation April 2013 - Present
Apnex Medical, Inc. August 2011 - March 2013
Apnex Medical October 2008 - August 2011
St. Jude Medical March 2008 - September 2008
Boston Scientific August 2004 - April 2007
Guidant Corporation August 2002 - August 2004
Guidant Corporation July 2001 - August 2002
Guidant Corporation October 1994 - July 2001
Cardiac Pacemakers, Inc September 1992 - October 1994
South Bay Cardiovascular Surgeons August 1979 - September 1992
Skills
Medical Devices, Strategic Planning, Clinical Trials, CTMS, Cath Lab, Pacemakers, Product Launch, FDA, Cardiology, Clinical Research, R&D, Biomedical Engineering, Interventional..., Clinical Data Management, Clinical Development, CRO, Clinical Monitoring, GCP, Urology, Electrophysiology, EDC, Protocol, Validation, Biotechnology, Vascular, Regulatory Affairs, Change Management, Process Improvement, Heart Failure, Design Control, ISO 13485, CAPA, Hardware Diagnostics, Operating Room, Cardiac Rhythm..., Cardiac Surgery, Surgery, Cardiac..., PMA, Medical Imaging, Neuromodulation, Quality System, Surgeons, Surgical Instruments, Medical Device R, Spine, Defibrillator, ISO 14971, Capital Equipment, Market Development
Education
Medical College of Georgia at Georgia Regents University 1977 — 1979
BS, Physician Assistant
University of California, Berkeley 1971 — 1975
AB, Physiology
Spinal Modulation April 2013 - Present
Apnex Medical, Inc. August 2011 - March 2013
Apnex Medical October 2008 - August 2011
St. Jude Medical March 2008 - September 2008
Boston Scientific August 2004 - April 2007
Guidant Corporation August 2002 - August 2004
Guidant Corporation July 2001 - August 2002
Guidant Corporation October 1994 - July 2001
Cardiac Pacemakers, Inc September 1992 - October 1994
South Bay Cardiovascular Surgeons August 1979 - September 1992
Skills
Medical Devices, Strategic Planning, Clinical Trials, CTMS, Cath Lab, Pacemakers, Product Launch, FDA, Cardiology, Clinical Research, R&D, Biomedical Engineering, Interventional..., Clinical Data Management, Clinical Development, CRO, Clinical Monitoring, GCP, Urology, Electrophysiology, EDC, Protocol, Validation, Biotechnology, Vascular, Regulatory Affairs, Change Management, Process Improvement, Heart Failure, Design Control, ISO 13485, CAPA, Hardware Diagnostics, Operating Room, Cardiac Rhythm..., Cardiac Surgery, Surgery, Cardiac..., PMA, Medical Imaging, Neuromodulation, Quality System, Surgeons, Surgical Instruments, Medical Device R, Spine, Defibrillator, ISO 14971, Capital Equipment, Market Development
Education
Medical College of Georgia at Georgia Regents University 1977 — 1979
BS, Physician Assistant
University of California, Berkeley 1971 — 1975
AB, Physiology
Steve Flom Steve Flom's Apnex Medical, Inc. Experience September 2012 - April 2013
Job Quality Management (Contractor) at EnteroMedics
Industry Medical Devices
Experience
EnteroMedics April 2013 - Present
Apnex Medical, Inc. September 2012 - April 2013
Apnex Medical December 2009 - November 2012
EnteroMedics September 2006 - October 2009
Prodesse Group Inc. July 2005 - September 2006
Lumina Engineering 2000 - 2006
Lumina Engineering October 2000 - July 2005
Honeywell Aerospace 1995 - 2000
Skills
Software Quality..., Software Project..., FDA, Medical Devices, Human Factors, ISO 13485, Validation, Engineering, Quality System, Design Control, Embedded Systems, R&D, Software Development, ISO 14971, Biomedical Engineering, Software Engineering, Quality Assurance, Testing, Design for Manufacturing, Product Development, FMEA, Systems Engineering, V&V, CAPA, 21 CFR Part 11, 21 CFR, Quality Management, ISO, Regulatory Affairs, Design of Experiments, Quality Control, CE marking, Minitab, Root Cause Analysis, Supplier Quality, SPC, GMP
Education
University of Minnesota-Twin Cities
BSEE, Electrical Engineering
University of Minnesota-Twin Cities
MSSE, Software Engineering
EnteroMedics April 2013 - Present
Apnex Medical, Inc. September 2012 - April 2013
Apnex Medical December 2009 - November 2012
EnteroMedics September 2006 - October 2009
Prodesse Group Inc. July 2005 - September 2006
Lumina Engineering 2000 - 2006
Lumina Engineering October 2000 - July 2005
Honeywell Aerospace 1995 - 2000
Skills
Software Quality..., Software Project..., FDA, Medical Devices, Human Factors, ISO 13485, Validation, Engineering, Quality System, Design Control, Embedded Systems, R&D, Software Development, ISO 14971, Biomedical Engineering, Software Engineering, Quality Assurance, Testing, Design for Manufacturing, Product Development, FMEA, Systems Engineering, V&V, CAPA, 21 CFR Part 11, 21 CFR, Quality Management, ISO, Regulatory Affairs, Design of Experiments, Quality Control, CE marking, Minitab, Root Cause Analysis, Supplier Quality, SPC, GMP
Education
University of Minnesota-Twin Cities
BSEE, Electrical Engineering
University of Minnesota-Twin Cities
MSSE, Software Engineering
Pam Quam Pam Quam's Apnex Medical, Inc. Experience September 2008 - September 2012
Job Seeking new opportunities at .
Industry Medical Devices
Experience
Apnex Medical, Inc. September 2008 - September 2012
Packaging, The Bergquist Company January 2005 - January 2008
Wausau Supply Company January 2004 - January 2005
Treasure Island Resort & Casino January 2003 - January 2004
Assembly, Medtronic Neurological Colombia January 1995 - January 2002
Possis Medical, INC January 1992 - January 1995
Skills
Medical Devices, Manufacturing, Inventory Management, Process Improvement, Troubleshooting, Product Development, Testing, Cross-functional Team..., Quality System, R, Process Simulation
Education
Blaine Sr. High
Hennepin Technical College
Minnesota School of Business
Apnex Medical, Inc. September 2008 - September 2012
Packaging, The Bergquist Company January 2005 - January 2008
Wausau Supply Company January 2004 - January 2005
Treasure Island Resort & Casino January 2003 - January 2004
Assembly, Medtronic Neurological Colombia January 1995 - January 2002
Possis Medical, INC January 1992 - January 1995
Skills
Medical Devices, Manufacturing, Inventory Management, Process Improvement, Troubleshooting, Product Development, Testing, Cross-functional Team..., Quality System, R, Process Simulation
Education
Blaine Sr. High
Hennepin Technical College
Minnesota School of Business
Robert Atkinson Robert Atkinson's Apnex Medical, Inc. Experience 2006 - 2011
Job Entrepreneur, Executive and Patent Attorney
Industry Medical Devices
Experience
Prospex Medical 2005 - Present
ClarVista Medical, Inc. 2013 - Present
OcuTherix, Inc. 2014 - 2015
Apnex Medical, Inc. 2006 - 2011
BridgePoint Medical, Inc. 2005 - 2006
Myocor 2003 - 2005
Transoma Medical 2003 - 2005
Private Firm 1998 - 2003
Boston Scientific 1993 - 1998
SCIMED 1989 - 1993
Skills
Patents, Intellectual Property, Medical Devices, Start-ups, Regulatory Affairs, Clinical Trials, Entrepreneurship, Biotechnology, ISO 13485, Venture Capital, FDA, Research, Systems Engineering, R&D, Product Development, Biomedical Engineering, Product Launch, Commercialization, Engineering, Validation, Market Development, Cross-functional Team..., Quality System, Design Control, Strategic Planning, New Business Development
Education
William Mitchell College of Law 1993 — 1997
JD, Law
University of Minnesota-Twin Cities
BS, Mechanical Engineering
Prospex Medical 2005 - Present
ClarVista Medical, Inc. 2013 - Present
OcuTherix, Inc. 2014 - 2015
Apnex Medical, Inc. 2006 - 2011
BridgePoint Medical, Inc. 2005 - 2006
Myocor 2003 - 2005
Transoma Medical 2003 - 2005
Private Firm 1998 - 2003
Boston Scientific 1993 - 1998
SCIMED 1989 - 1993
Skills
Patents, Intellectual Property, Medical Devices, Start-ups, Regulatory Affairs, Clinical Trials, Entrepreneurship, Biotechnology, ISO 13485, Venture Capital, FDA, Research, Systems Engineering, R&D, Product Development, Biomedical Engineering, Product Launch, Commercialization, Engineering, Validation, Market Development, Cross-functional Team..., Quality System, Design Control, Strategic Planning, New Business Development
Education
William Mitchell College of Law 1993 — 1997
JD, Law
University of Minnesota-Twin Cities
BS, Mechanical Engineering
Terry Pertile Terry Pertile's Apnex Medical, Inc. Experience October 2010 - February 2013
Job President at Clarity Clinical Consulting, LLC
Industry Medical Devices
Experience
Clarity Clinical Consulting, LLC February 2013 - Present
Apnex Medical, Inc. October 2010 - February 2013
Osprey Medical, Inc February 2008 - October 2010
MAPS Applied Research Center January 2007 - February 2008
CVRx July 2003 - December 2006
Orphan Medical September 1999 - July 2003
Skills
Clinical Development, Clinical Trials, Clinical Research, Medical Devices, Biomedical Engineering, FDA, CTMS, R&D, GCP, CRO, Biotechnology, Cardiology, Medical Writing, Regulatory Requirements, Protocol, Clinical Study Design, Therapeutic Areas, Sop, EDC, GLP, Clinical Monitoring, ISO 13485
Education
University of Minnesota-Twin Cities 1989 — 1995
PhD, Microbiology and Immunology
Macalester College 1981 — 1985
BA, Biology
Clarity Clinical Consulting, LLC February 2013 - Present
Apnex Medical, Inc. October 2010 - February 2013
Osprey Medical, Inc February 2008 - October 2010
MAPS Applied Research Center January 2007 - February 2008
CVRx July 2003 - December 2006
Orphan Medical September 1999 - July 2003
Skills
Clinical Development, Clinical Trials, Clinical Research, Medical Devices, Biomedical Engineering, FDA, CTMS, R&D, GCP, CRO, Biotechnology, Cardiology, Medical Writing, Regulatory Requirements, Protocol, Clinical Study Design, Therapeutic Areas, Sop, EDC, GLP, Clinical Monitoring, ISO 13485
Education
University of Minnesota-Twin Cities 1989 — 1995
PhD, Microbiology and Immunology
Macalester College 1981 — 1985
BA, Biology
Lynn Suilmann Lynn Suilmann's Apnex Medical, Inc. Experience September 2010 - December 2012
Job Information Technology Systems Analyst Chief Clerk's Office at Minnesota House of Representatives
Industry Information Technology and Services
Experience
Minnesota House of Representatives March 2014 - Present
ISD 192 Farmington Public School System October 2012 - March 2014
Apnex Medical, Inc. September 2010 - December 2012
United Rentals June 2007 - June 2010
Fastenal 1992 - 2007
Geometric Design 1989 - 1992
Fastenal 1982 - 1989
Skills
Project Management, Sales, Change Management, Customer Service, Cross-functional Team..., Leadership, New Business Development, Manufacturing, Sales Management, IT Operations Management, Product Development, Account Management, Purchasing, Customer Satisfaction, Budgets, Sales Operations, IT Solutions, Inventory Management, Forecasting, Microsoft Word, Strategic Planning, Sales Process, Direct Sales, IT Operations, IT Management, Customer Relations, Microsoft Office, Operations Management, Selling, Medical Devices, Microsoft Excel, Team Building, Training, Networking, Security, Process Improvement, Problem Solving, Budgeting, Compliance, Consultative Selling, B2B, Excel, Sales Support, Planning, Salesforce.com, Word, P&L, IT Strategy, IT Infrastructure..., IT Service Management
Education
Minnesota State University, Mankato 1983 — 1985
BS, Business, Economics
IT Training Center 2010 — 2012
CompTIA Network +, MCSA
Saint Mary's University of Minnesota 1978 — 1981
Minnesota House of Representatives March 2014 - Present
ISD 192 Farmington Public School System October 2012 - March 2014
Apnex Medical, Inc. September 2010 - December 2012
United Rentals June 2007 - June 2010
Fastenal 1992 - 2007
Geometric Design 1989 - 1992
Fastenal 1982 - 1989
Skills
Project Management, Sales, Change Management, Customer Service, Cross-functional Team..., Leadership, New Business Development, Manufacturing, Sales Management, IT Operations Management, Product Development, Account Management, Purchasing, Customer Satisfaction, Budgets, Sales Operations, IT Solutions, Inventory Management, Forecasting, Microsoft Word, Strategic Planning, Sales Process, Direct Sales, IT Operations, IT Management, Customer Relations, Microsoft Office, Operations Management, Selling, Medical Devices, Microsoft Excel, Team Building, Training, Networking, Security, Process Improvement, Problem Solving, Budgeting, Compliance, Consultative Selling, B2B, Excel, Sales Support, Planning, Salesforce.com, Word, P&L, IT Strategy, IT Infrastructure..., IT Service Management
Education
Minnesota State University, Mankato 1983 — 1985
BS, Business, Economics
IT Training Center 2010 — 2012
CompTIA Network +, MCSA
Saint Mary's University of Minnesota 1978 — 1981
Laura Goding Laura Goding's Apnex Medical, Inc. Experience May 2011 - January 2013
Job Project Coordinator III
Industry Medical Devices
Experience
Medtronic July 2014 - Present
Prime Therapeutics February 2014 - June 2014
Lifetime June 2012 - February 2014
Apnex Medical, Inc. May 2011 - January 2013
Panera Bread May 2010 - January 2012
Skills
Customer Service, Data Analysis, Data Entry, Technical Writing, Report Writing, Stressful Situations, Organization, Presentations, Microsoft Excel, Communication, Research, Microsoft Word, Microsoft Office, PowerPoint, Teamwork, Leadership, Market Research, Analysis, Matlab, C++ Language, Electronic Circuit..., File Management, Time Management, Critical Thinking, Public Speaking, Biomedical Engineering, Coordination, Customer Satisfaction, R&D, Clinical Research, Team-oriented, Lifesciences, People Skills, Outlook, Quality Assurance, FDA, Medical Devices, Social Media, Problem Solving
Education
University of Minnesota-Twin Cities 2009 — 2013
Bachelor of Science (B.S.), Health and Wellness Core with focus in Biomedical Research
Medtronic July 2014 - Present
Prime Therapeutics February 2014 - June 2014
Lifetime June 2012 - February 2014
Apnex Medical, Inc. May 2011 - January 2013
Panera Bread May 2010 - January 2012
Skills
Customer Service, Data Analysis, Data Entry, Technical Writing, Report Writing, Stressful Situations, Organization, Presentations, Microsoft Excel, Communication, Research, Microsoft Word, Microsoft Office, PowerPoint, Teamwork, Leadership, Market Research, Analysis, Matlab, C++ Language, Electronic Circuit..., File Management, Time Management, Critical Thinking, Public Speaking, Biomedical Engineering, Coordination, Customer Satisfaction, R&D, Clinical Research, Team-oriented, Lifesciences, People Skills, Outlook, Quality Assurance, FDA, Medical Devices, Social Media, Problem Solving
Education
University of Minnesota-Twin Cities 2009 — 2013
Bachelor of Science (B.S.), Health and Wellness Core with focus in Biomedical Research
Dale Schak Dale Schak's Apnex Medical, Inc. Experience June 2012 - September 2012
Job Manufacturing Engineer at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical August 2014 - Present
Covidien August 2013 - July 2014
Terumo Cardiovascular Systems January 2013 - July 2013
Apnex Medical, Inc. June 2012 - September 2012
American Medical Systems November 2011 - June 2012
Apnex Medical, Inc. January 2011 - November 2011
Olympus Medical (Fomerly Gyrus ACMI Medical) November 2008 - March 2010
Medtronic September 1997 - October 2005
Skills
Medical Devices, FDA, ISO 13485, Biomedical Engineering, Design Control, Lean Manufacturing, Validation, R&D, Solidworks, Product Development, V&V, Design of Experiments, Design for Manufacturing, CAPA, Manufacturing, Quality System, FMEA, Manufacturing..., Process Simulation, SPC, Product Launch, Root Cause Analysis, GMP, ISO, Quality Control, Minitab, Cross-functional Team..., Product Design
Education
University of Minnesota-Twin Cities 1994 — 1998
B.S., Mat Sci
St. Jude Medical August 2014 - Present
Covidien August 2013 - July 2014
Terumo Cardiovascular Systems January 2013 - July 2013
Apnex Medical, Inc. June 2012 - September 2012
American Medical Systems November 2011 - June 2012
Apnex Medical, Inc. January 2011 - November 2011
Olympus Medical (Fomerly Gyrus ACMI Medical) November 2008 - March 2010
Medtronic September 1997 - October 2005
Skills
Medical Devices, FDA, ISO 13485, Biomedical Engineering, Design Control, Lean Manufacturing, Validation, R&D, Solidworks, Product Development, V&V, Design of Experiments, Design for Manufacturing, CAPA, Manufacturing, Quality System, FMEA, Manufacturing..., Process Simulation, SPC, Product Launch, Root Cause Analysis, GMP, ISO, Quality Control, Minitab, Cross-functional Team..., Product Design
Education
University of Minnesota-Twin Cities 1994 — 1998
B.S., Mat Sci
Keith Jasperson's Apnex Medical, Inc. Experience May 2007 - June 2008
Job Program Director at superDimension, Inc.
Industry Medical Devices
Experience
Medtronic Minimally Invasive Therapies Group January 2015 - Present
superDimension / Covidien June 2008 - January 2015
Apnex Medical, Inc. May 2007 - June 2008
Transoma Medical September 2004 - May 2007
Medtronic February 1997 - August 2004
3M June 1987 - January 1997
Skills
Medical Devices, ISO 13485, Design Control, FDA, Neurology, Biomedical Engineering, R&D, CAPA, Quality System, Product Launch, Capital Equipment, V&V, Cross-functional Team..., Validation, Market Development, Product Development, Commercialization, Design of Experiments, Operating Room, Cardiology
Education
University of Minnesota-Twin Cities 1987 — 1993
Master's degree, Electrical and Electronics Engineering
University of Iowa 1982 — 1987
Bachelor of Science (BS), Electrical and Electronics Engineering
Medtronic Minimally Invasive Therapies Group January 2015 - Present
superDimension / Covidien June 2008 - January 2015
Apnex Medical, Inc. May 2007 - June 2008
Transoma Medical September 2004 - May 2007
Medtronic February 1997 - August 2004
3M June 1987 - January 1997
Skills
Medical Devices, ISO 13485, Design Control, FDA, Neurology, Biomedical Engineering, R&D, CAPA, Quality System, Product Launch, Capital Equipment, V&V, Cross-functional Team..., Validation, Market Development, Product Development, Commercialization, Design of Experiments, Operating Room, Cardiology
Education
University of Minnesota-Twin Cities 1987 — 1993
Master's degree, Electrical and Electronics Engineering
University of Iowa 1982 — 1987
Bachelor of Science (BS), Electrical and Electronics Engineering
Ginny Kirby's Apnex Medical, Inc. Experience 2007 - 2013
Job Consultant, Clinical Regulatory Strategy and Operations at V.M. Kirby Consulting
Industry Medical Devices
Experience
V.M. Kirby Consulting 2013 - Present
Apnex Medical, Inc. 2007 - 2013
EnteroMedics 2005 - 2006
ev3 2003 - 2005
Medtronic 2002 - 2003
Medtronic 1999 - 2001
Medtronic 1997 - 1998
Skills
Biomedical Engineering, R&D, Design Control, Medical Devices, Clinical Trials, Pacemakers, Clinical Research, FDA, GCP, ISO 13485, Clinical Development, V&V, Regulatory Affairs, Product Launch, CTMS, CAPA, 21 CFR Part 11
Education
University of MN - Carlson School of Management/IT
M.S., Management of Technology
Purdue University
M.S., Audiology and Speech Science
V.M. Kirby Consulting 2013 - Present
Apnex Medical, Inc. 2007 - 2013
EnteroMedics 2005 - 2006
ev3 2003 - 2005
Medtronic 2002 - 2003
Medtronic 1999 - 2001
Medtronic 1997 - 1998
Skills
Biomedical Engineering, R&D, Design Control, Medical Devices, Clinical Trials, Pacemakers, Clinical Research, FDA, GCP, ISO 13485, Clinical Development, V&V, Regulatory Affairs, Product Launch, CTMS, CAPA, 21 CFR Part 11
Education
University of MN - Carlson School of Management/IT
M.S., Management of Technology
Purdue University
M.S., Audiology and Speech Science
Deb Burton's Apnex Medical, Inc. Experience 2011 - 2012
Job Clinical Research Professional
Industry Medical Devices
Experience
Obalon Therapeutics February 2015 - Present
Intersect ENT May 2013 - February 2015
Apnex Medical, Inc. 2011 - 2012
ROX Medical 2009 - 2011
Broncus Technologies, Inc 2007 - 2009
Boston Scientific 1997 - 2007
Skills
Medical Devices, Cardiology, Clinical Trials, Cardiac, Clinical Research, Heart Failure, Electrophysiology, Pacemakers, Clinical Trial..., Interventional..., Research, Nursing, Sleep Apnea, Clinical Development, ISO 13485, GCP, Protocol
Education
Duquesne University
BSN, Nursing
Obalon Therapeutics February 2015 - Present
Intersect ENT May 2013 - February 2015
Apnex Medical, Inc. 2011 - 2012
ROX Medical 2009 - 2011
Broncus Technologies, Inc 2007 - 2009
Boston Scientific 1997 - 2007
Skills
Medical Devices, Cardiology, Clinical Trials, Cardiac, Clinical Research, Heart Failure, Electrophysiology, Pacemakers, Clinical Trial..., Interventional..., Research, Nursing, Sleep Apnea, Clinical Development, ISO 13485, GCP, Protocol
Education
Duquesne University
BSN, Nursing
Patti Hatchett, CCRP's Apnex Medical, Inc. Experience August 2011 - January 2013
Job Clinical Research Professional
Industry Research
Experience
Torax Medical, Inc. May 2014 - Present
NAMSA November 2013 - May 2014
Apnex Medical, Inc. August 2011 - January 2013
St. Jude Medical, formerly AGA Medical Corp June 2009 - May 2011
Uptake Medical March 2008 - May 2009
St. Jude Medical July 2006 - February 2008
Acorn Cardiovascular, Inc October 2002 - May 2006
Personnel Decisions Intl 1995 - 2001
Personnel Decisions, Inc. February 1989 - 1995
Skills
Clinical Trials, Clinical Monitoring, GCP, Clinical Research, Medical Devices, FDA, EDC, Protocol, Clinical Study Design, CRO, CTMS, Sop, Cardiology, ICH-GCP, Clinical Data Management, Clinical Development, Clinical, WIRB, CRF Design, SOP
Education
Minnesota State University, Mankato
B.S., Sociology/Corrections
Torax Medical, Inc. May 2014 - Present
NAMSA November 2013 - May 2014
Apnex Medical, Inc. August 2011 - January 2013
St. Jude Medical, formerly AGA Medical Corp June 2009 - May 2011
Uptake Medical March 2008 - May 2009
St. Jude Medical July 2006 - February 2008
Acorn Cardiovascular, Inc October 2002 - May 2006
Personnel Decisions Intl 1995 - 2001
Personnel Decisions, Inc. February 1989 - 1995
Skills
Clinical Trials, Clinical Monitoring, GCP, Clinical Research, Medical Devices, FDA, EDC, Protocol, Clinical Study Design, CRO, CTMS, Sop, Cardiology, ICH-GCP, Clinical Data Management, Clinical Development, Clinical, WIRB, CRF Design, SOP
Education
Minnesota State University, Mankato
B.S., Sociology/Corrections
Kimberly Trotter's Apnex Medical, Inc. Experience January 2009 - May 2013
Job Administrative Director at UCSF Sleep Disorders Center
Industry Hospital & Health Care
Experience
UCSF Medical Center August 1994 - Present
AAST March 2014 - Present
AAST A2Zzz Magazine January 1998 - Present
Vallejo Naval and Historical Museum September 2009 - August 2013
Apnex Medical, Inc. January 2009 - May 2013
California Sleep Society July 2007 - January 2012
American Association of Sleep Technologists August 1998 - June 2010
Vallejo Beautification Advisory Commission August 2004 - January 2010
APT 1991 - 1998
Skills
Budgets, Medical Devices, Research, Marketing, Physicians, Healthcare, Public Speaking, Sleep Disorders, Nonprofits, Management, Patient Education, Healthcare Management, Clinical Research, Clinical Trials, Obstructive Sleep Apnea, Healthcare Information..., Hospitals, Pediatrics, EMR, Treatment
Education
California State University-Sacramento 1986 — 1990
Masters of Arts, Psychology
UCSF Medical Center August 1994 - Present
AAST March 2014 - Present
AAST A2Zzz Magazine January 1998 - Present
Vallejo Naval and Historical Museum September 2009 - August 2013
Apnex Medical, Inc. January 2009 - May 2013
California Sleep Society July 2007 - January 2012
American Association of Sleep Technologists August 1998 - June 2010
Vallejo Beautification Advisory Commission August 2004 - January 2010
APT 1991 - 1998
Skills
Budgets, Medical Devices, Research, Marketing, Physicians, Healthcare, Public Speaking, Sleep Disorders, Nonprofits, Management, Patient Education, Healthcare Management, Clinical Research, Clinical Trials, Obstructive Sleep Apnea, Healthcare Information..., Hospitals, Pediatrics, EMR, Treatment
Education
California State University-Sacramento 1986 — 1990
Masters of Arts, Psychology
Connor Lyons's Apnex Medical, Inc. Experience October 2012 - February 2013
Job Research Specialist at Waisman Biomanufacturing
Industry Pharmaceuticals
Experience
Waisman Biomanufacturing January 2013 - Present
Apnex Medical, Inc. October 2012 - February 2013
Centrose LLC November 2009 - June 2012
Schulze Diabetes Institute September 2008 - November 2009
Skills
Biotechnology, ELISA, Assay Development, Drug Discovery, Pharmaceutical Industry, Cell Culture, Protein Chemistry, Lifesciences, Clinical Trials, Clinical Development, Oncology, Sop, Fluorescence Microscopy, DNA, Matlab
Education
University of Minnesota-Twin Cities 2004 — 2008
Bachelor of Science (BS), Biomedical Engineering
Waisman Biomanufacturing January 2013 - Present
Apnex Medical, Inc. October 2012 - February 2013
Centrose LLC November 2009 - June 2012
Schulze Diabetes Institute September 2008 - November 2009
Skills
Biotechnology, ELISA, Assay Development, Drug Discovery, Pharmaceutical Industry, Cell Culture, Protein Chemistry, Lifesciences, Clinical Trials, Clinical Development, Oncology, Sop, Fluorescence Microscopy, DNA, Matlab
Education
University of Minnesota-Twin Cities 2004 — 2008
Bachelor of Science (BS), Biomedical Engineering
Tiffany Schmidt, CCRP's Apnex Medical, Inc. Experience August 2011 - October 2012
Job Research Operations Officer at CentraCare Health System
Industry Medical Devices
Experience
CentraCare Health System August 2013 - Present
Medpace Medical Device October 2012 - August 2013
Apnex Medical, Inc. August 2011 - October 2012
St. Jude Medical October 2007 - August 2011
Anulex Technologies October 2006 - October 2007
Medtronic March 2006 - October 2006
St. Cloud Hospital August 2002 - March 2006
Skills
CTMS, Clinical Data Management, Clinical Monitoring, Clinical Research, Clinical Study Design, Clinical Trials, EDC, FDA, GCP, Medical Devices, Biotechnology, CRO, Cardiology, Clinical Development, Regulatory Affairs
Education
St. Cloud State University 2000 — 2005
Bachelor of Science, Biological Sciences
SOCRA Certified
CentraCare Health System August 2013 - Present
Medpace Medical Device October 2012 - August 2013
Apnex Medical, Inc. August 2011 - October 2012
St. Jude Medical October 2007 - August 2011
Anulex Technologies October 2006 - October 2007
Medtronic March 2006 - October 2006
St. Cloud Hospital August 2002 - March 2006
Skills
CTMS, Clinical Data Management, Clinical Monitoring, Clinical Research, Clinical Study Design, Clinical Trials, EDC, FDA, GCP, Medical Devices, Biotechnology, CRO, Cardiology, Clinical Development, Regulatory Affairs
Education
St. Cloud State University 2000 — 2005
Bachelor of Science, Biological Sciences
SOCRA Certified
Cody Hanson's Apnex Medical, Inc. Experience 2008 - 2012
Job Medical Devices Professional
Industry Medical Devices
Experience
Apnex Medical, Inc. 2008 - 2012
Education
University of Minnesota-Twin Cities
Biomedical/Medical Engineering
Apnex Medical, Inc. 2008 - 2012
Education
University of Minnesota-Twin Cities
Biomedical/Medical Engineering
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY