Apnex Medical

Industry: Company

Description

Founded: 2006

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Apnex Medical Employees

Employee
Years
Job
Industry
Gina Risdall Gina Risdall Greater Minneapolis-St. Paul Area Details
Gina Risdall's Apnex Medical Experience January 2010 - January 2013
Job Clinical Site Manager at Cardiovascular Systems, Inc.
Industry Medical Devices
Experience
Cardiovascular Systems, Inc.   October 2014 - Present
NAMSA  July 2013 - September 2014
Apnex Medical   January 2010 - January 2013
MN Sleep Institute   September 2002 - December 2009
LabCorp  September 2001 - September 2002

Skills
Clinical Research, Medical Devices, Clinical Trials, FDA, R&D, Data Analysis, Healthcare, Clinical Data Management, Data Collection, Research, Managing clinical..., Cross-functional Team..., Product Development, Clinical Development, Clinical Monitoring, Lifesciences, Biotechnology, CAPA, CRO, Evaluate and analyze..., Create source documents, ISO 13485, CTMS, GCP, EDC, Cardiology, Project Management, Develop improved..., Assist in preparation..., PMA, ISO 9001, IDE, Quality System, Regulatory Submissions, Protocol

Education
University of St. Thomas   2013 — 2016
Master's of Science (M.S.), Regulatory Science/Engineering

University of Minnesota Duluth   1997 — 2000
BS, Biology and Chemistry

Andrea Stone Andrea Stone Osseo, Minnesota Details
Andrea Stone's Apnex Medical Experience March 2010 - November 2012
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

Steve Nunley Steve Nunley Greater Minneapolis-St. Paul Area Details
Steve Nunley's Apnex Medical Experience October 2008 - August 2011
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

Steve Flom Steve Flom Greater Minneapolis-St. Paul Area Details
Steve Flom's Apnex Medical Experience December 2009 - November 2012
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

Chas McKhann Chas McKhann Greater Minneapolis-St. Paul Area Details
Chas McKhann's Apnex Medical Experience June 2010 - 2012
Job Chief Commercial Officer at Intersect ENT
Industry Medical Devices
Experience
Intersect ENT  February 2015 - Present
Monitor Deloitte  December 2013 - January 2015
CSM Medical   January 2013 - November 2013
Apnex Medical   June 2010 - 2012
Boston Scientific  August 2007 - April 2010
Boston Scientific  January 2007 - August 2007
Cordis  April 2003 - January 2007
McKinsey & Company  August 1998 - March 2003
SCA Consulting  1994 - 1996

Skills
Market Development, Medical Devices, Start-ups, Commercialization, Strategic Planning, Marketing, New Business Development, Management Consulting, Product Development, Strategy, Product Launch, Healthcare, Surgery, CRM, Management, Leadership, Competitive Analysis, Cross-functional Team..., Product Marketing, Sales Operations, Lifesciences

Education
Stanford University Graduate School of Business   1996 — 1998
MBA

Stanford University   1987 — 1991
BA, Political Science, Economics

Dale Suilmann Dale Suilmann Greater Minneapolis-St. Paul Area Details
Dale Suilmann's Apnex Medical Experience February 2008 - September 2012
Job System/Software Consulting at Rainy Hill, Inc.
Industry Medical Devices
Experience
Rainy Hill, Inc.   September 2012 - Present
Apnex Medical   February 2008 - September 2012
Medtronic Inc.  2000 - 2008
Rivertek Medical Systems   1997 - 2000
PharmaTarget   May 1996 - November 1997
Guidant  August 1987 - April 1995
Honeywell  1983 - 1987
Rockwell-Collins  1981 - 1983
Coe College  1980 - 1981

Skills
Software Development, Software Design, Engineering, Medical Devices, Process Development, Biomedical Engineering, Embedded Systems, FDA, Software Engineering, R&D, Design Control, Process Simulation, Product Development, Embedded Software, Cross-functional Team..., ISO 14971, Firmware, Testing, Systems Engineering, Design of Experiments, Design for Manufacturing, ISO 13485, Validation, Quality System, V&V, Engineering Management, System Design, Requirements Management, Sensors, System Architecture, Electronics, Technical Leadership, RTOS, Telelogic DOORS, Minitab, FMEA, Manufacturing, 21 CFR Part 11, CAPA, Digital Signal..., Product Launch, SPC, Signal Processing, Commercialization, Debugging, Object Oriented Design, Device Drivers, Matlab, Hardware Architecture, Labview

Education
University of Iowa   1978 — 1980
MS

Saint Mary's University of Minnesota   1974 — 1978
BA

Wabasha High School   1970 — 1974

Jason Skubitz Jason Skubitz Greater Minneapolis-St. Paul Area Details
Jason Skubitz's Apnex Medical Experience March 2010 - March 2011
Job Director, Product Development and Operations at Mainstay Medical
Industry Medical Devices
Experience
Mainstay Medical   December 2012 - Present
Apnex Medical, Inc  March 2010 - December 2012
Apnex Medical   March 2010 - March 2011
Leptos Biomedical  June 2007 - May 2010
St. Croix Medical (Envoy)   September 2000 - June 2007
Boston Scientific / Guidant Corp   1996 - 2000

Education
University of Minnesota-Twin Cities   1991 — 1996
BS, Mechanical Engineering

Dave Matson Dave Matson Greater Minneapolis-St. Paul Area Details
Dave Matson's Apnex Medical Experience May 2008 - September 2012
Job Director of Quality at Holaira, Inc.
Industry Medical Devices
Experience
Holaira, Inc.   January 2013 - Present
EnteroMedics  September 2012 - January 2013
Apnex Medical   May 2008 - September 2012
Boston Scientific  January 2005 - April 2008
CVRx, Inc   2002 - 2005
TERAMed, Inc.   1998 - 2002
Vascular Solutions  1997 - 1998
SciMed Life Systems  1991 - 1997

Skills
ISO 13485, Medical Devices, Design Control, ISO 14971, V&V, FDA, CAPA, Minitab, Validation, 21 CFR Part 11, Quality System, Design of Experiments, Manufacturing, Regulatory Submissions, Supplier Quality, FMEA, Product Development, R&D, Quality Control, Design for Manufacturing, Lifesciences, SPC, Cross-functional Team..., 21 CFR, Biomedical Engineering, Biotechnology, Quality Assurance

Education
University of Minnesota-Twin Cities
BS, Statistics

Norma Padrnos-Usset Norma Padrnos-Usset Greater Minneapolis-St. Paul Area Details
Norma Padrnos-Usset's Apnex Medical Experience November 2008 - February 2009
Job Production Control Manager at Atlas Manufacturing
Industry Medical Devices
Experience
Atlas Manufacturing  April 2010 - Present
ProMed Molding   March 2004 - April 2010
Ionix Medical   April 2009 - March 2010
Apnex Medical   November 2008 - February 2009
CVRx Inc   October 2005 - October 2008
NeoMetrics Inc  January 2004 - June 2005
Enpath Medical  November 2002 - June 2004
Williams Steel and Hardware   2001 - 2004
CarTika Medical   1996 - 2000
ERP Consultant   1996 - 1998

Skills
Quality System, Software Documentation, Process Improvement, Lean Manufacturing, Management, ISO, ERP, Manufacturing, Cross-functional Team..., Leadership, ISO 13485

Education
University of Minnesota - Carlson School of Management   1982 — 1986
MBA, Concentration in Operations

University of Minnesota-Twin Cities   1975 — 1979
BS, Economics

Paula Kaplan Paula Kaplan Greater Minneapolis-St. Paul Area Details
Paula Kaplan's Apnex Medical Experience August 2007 - April 2009
Job Principal Design Assurance Engineer at Cardiovascular Systems, Inc.
Industry Medical Devices
Experience
Cardiovascular Systems, Inc.   April 2009 - Present
Apnex Medical   August 2007 - April 2009
Enpath Medical  2006 - 2007
MEDTRONIC-Neuro  2004 - 2006
Medtronic-CRDM  2000 - 2004
Medtronic  1996 - 2000
Boston Scientific Guidant/CPI   1992 - 1995

Skills
FDA, Medical Devices, Design Control, Product Development, DFMEA, Hazard Analysis, Biocompatibility, Design..., Neuro Leads Design, Risk Management

Education
University of Minnesota-Twin Cities
BS, Mechanical Engineering

University of Minnesota-Twin Cities
MS, Physiology

University of St. Thomas
MS, Manufacturing Systems

Dwight Skinner Dwight Skinner Greater Minneapolis-St. Paul Area Details
Dwight Skinner's Apnex Medical Experience November 2007 - October 2009
Job Principal Design Engineer at Medtronic
Industry Medical Devices
Experience
Medtronic  May 2015 - Present
Skinner Medical LLC   April 2015 - Present
Smiths Medical  May 2014 - April 2015
Covidien  July 2013 - May 2014
Covidien  February 2012 - July 2013
Covidien  March 2011 - February 2012
Greatbatch Medical  October 2009 - March 2011
Apnex Medical   November 2007 - October 2009
Medtronic  November 2000 - November 2007
Guidant  March 1997 - November 2000

Skills
Medical Devices, V&V, Quality System, Validation, Design for Manufacturing, FMEA, Six Sigma, Manufacturing, Lean Manufacturing, Product Development, Catheters, Testing, Process Simulation, Design Control, ISO 13485

Education
Case Western Reserve University   1992 — 1996
B.S., Mechanical Engineering

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