AxioMed Spine Corporation
Industry: Company
DescriptionFounded: 2001
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AxioMed Spine Corporation Employees
Employee
Years
Job
Industry
Kari Zimmers Kari Zimmers's AxioMed Spine Corporation Experience March 2003 - November 2014
Job Senior Vice President, Research & Development at AxioMed LLC
Industry Biotechnology
Experience
K.Z. Consulting November 2014 - June 2015
AxioMed Spine Corporation March 2003 - November 2014
Consultant / Self-Employed October 1999 - November 2001
DePuy AcroMed, A J&J Company November 1990 - June 1999
Firestone May 1989 - November 1990
Skills
Lifesciences, FDA, Biomedical Engineering, Strategy, Orthopedic, Design Control, Project Management, Medical Devices, Strategic Planning, R&D, Start-ups, Clinical Trials, Product Development, Spine, Cross-functional Team..., Design for Manufacturing, ISO 13485, Quality Assurance, Design of Experiments, Surgical Instruments, Regulatory Affairs, Quality System, Validation, Biotechnology, V&V, CAPA, Clinical Research, Medical Imaging, Polymers, Commercialization, Technology Transfer, Biomaterials, CE marking, GMP, ISO 14971, Tissue Engineering, Product Launch, Life Sciences, Orthopedics
Education
Pennsylvania State University 1985 — 1989
Bachelor of Science (B.S.), Polymer Science
K.Z. Consulting November 2014 - June 2015
AxioMed Spine Corporation March 2003 - November 2014
Consultant / Self-Employed October 1999 - November 2001
DePuy AcroMed, A J&J Company November 1990 - June 1999
Firestone May 1989 - November 1990
Skills
Lifesciences, FDA, Biomedical Engineering, Strategy, Orthopedic, Design Control, Project Management, Medical Devices, Strategic Planning, R&D, Start-ups, Clinical Trials, Product Development, Spine, Cross-functional Team..., Design for Manufacturing, ISO 13485, Quality Assurance, Design of Experiments, Surgical Instruments, Regulatory Affairs, Quality System, Validation, Biotechnology, V&V, CAPA, Clinical Research, Medical Imaging, Polymers, Commercialization, Technology Transfer, Biomaterials, CE marking, GMP, ISO 14971, Tissue Engineering, Product Launch, Life Sciences, Orthopedics
Education
Pennsylvania State University 1985 — 1989
Bachelor of Science (B.S.), Polymer Science
David Floyd David Floyd's AxioMed Spine Corporation Experience March 2004 - August 2005
Job Medical Device Executive
Industry Medical Devices
Experience
Stryker November 2012 - Present
OrthoWorx 2011 - 2012
DePuy Orthopaedics 2007 - 2011
Abbott Spine 2005 - 2007
AxioMed Spine Corporation March 2004 - August 2005
Centerpulse Orthopedics 2000 - 2003
Skills
Orthopedics, Medical Devices, Spine, Strategic Planning, Surgical Instruments, Orthopedic, Market Development, Surgeons, Capital Equipment, Start-ups, Biomedical Engineering, Healthcare, Operating Room, Surgery, Hospitals, Clinical Research, Product Launch, Leadership, FDA, Venture Capital, Product Development, ISO 13485, Biomechanics, Neurosurgery, Biotechnology, Commercialization, R&D, Sports Medicine
Education
Grace College & Seminary 1979 — 1983
B.S., Psychology
Ball State University
Stryker November 2012 - Present
OrthoWorx 2011 - 2012
DePuy Orthopaedics 2007 - 2011
Abbott Spine 2005 - 2007
AxioMed Spine Corporation March 2004 - August 2005
Centerpulse Orthopedics 2000 - 2003
Skills
Orthopedics, Medical Devices, Spine, Strategic Planning, Surgical Instruments, Orthopedic, Market Development, Surgeons, Capital Equipment, Start-ups, Biomedical Engineering, Healthcare, Operating Room, Surgery, Hospitals, Clinical Research, Product Launch, Leadership, FDA, Venture Capital, Product Development, ISO 13485, Biomechanics, Neurosurgery, Biotechnology, Commercialization, R&D, Sports Medicine
Education
Grace College & Seminary 1979 — 1983
B.S., Psychology
Ball State University
Courtney Maguire Courtney Maguire's AxioMed Spine Corporation Experience June 2010 - October 2014
Job Senior Clinical Research Associate at C.R. Bard Corporate Clinical Affairs
Industry Biotechnology
Experience
Galderma September 2015 - Present
C.R. Bard Corporate Clinical Affairs January 2015 - August 2015
AxioMed Spine Corporation June 2010 - October 2014
AxioMed Spine Corporation May 2009 - May 2010
AxioMed Spine Corporation December 2008 - April 2009
Case Western Reserve University, Cancer Center April 2006 - December 2008
Skills
Life Sciences, Biotechnology, Cross-functional Team..., FDA, Research, Clinical Trials, Medical Devices, Regulatory Affairs, IDE, Healthcare, Project Management, CE marking, IRB, Spine, Site Management, Regulatory Submissions, Clinical Monitoring, Clinical Research, CRF design, Protocol Development, GCP, ICH-GCP, Protocol
Education
Weatherhead School of Management at Case Western Reserve University
Master of Business Administration (MBA)
The University of Texas at Dallas
Bachelor of Arts (BA), Biology
Galderma September 2015 - Present
C.R. Bard Corporate Clinical Affairs January 2015 - August 2015
AxioMed Spine Corporation June 2010 - October 2014
AxioMed Spine Corporation May 2009 - May 2010
AxioMed Spine Corporation December 2008 - April 2009
Case Western Reserve University, Cancer Center April 2006 - December 2008
Skills
Life Sciences, Biotechnology, Cross-functional Team..., FDA, Research, Clinical Trials, Medical Devices, Regulatory Affairs, IDE, Healthcare, Project Management, CE marking, IRB, Spine, Site Management, Regulatory Submissions, Clinical Monitoring, Clinical Research, CRF design, Protocol Development, GCP, ICH-GCP, Protocol
Education
Weatherhead School of Management at Case Western Reserve University
Master of Business Administration (MBA)
The University of Texas at Dallas
Bachelor of Arts (BA), Biology
David Blattenberger's AxioMed Spine Corporation Experience May 2011 - September 2014
Job President of DLB Consulting Services, LLC
Industry Medical Devices
Experience
DLB Consulting Services, LLC February 2008 - Present
HMI Industries Inc. November 2014 - July 2015
TRN Technical October 2014 - November 2014
AxioMed Spine Corporation May 2011 - September 2014
Gebauer Company 2007 - 2008
ScottCare Corporation, div of Scott Fetzer, div of Berkshire Hathaway August 2005 - March 2007
ElectroSonics Medical Inc. May 2004 - August 2005
Beckman Coulter, Inc. February 1996 - April 2004
Mentor Corporation May 1994 - February 1996
Medtronic, Inc. February 1984 - May 1994
Skills
Regulatory Affairs, FDA, ISO 13485, Quality Systems, Medical Devices, Quality Assurance, Design of Experiments, Design Control, Process Validation, CAPA, Validation, Quality Management, FMEA, Quality Engineering, Six Sigma, Continuous Improvement, ISO 14971, cGMP, QSR, Compliance, GLP, Cross-functional Team..., Risk Management, Statistics, R&D, Document Management, SPC, Technical Writing, Program Management, Testing, Quality System, GMP, V&V, Product Development, Manufacturing, Quality Control, Regulatory Submissions, Quality Auditing, 21 CFR Part 11, Biomedical Engineering, Process Improvement, Computer System..., Process Simulation, GxP, Regulatory Requirements, 21 CFR, DMAIC, Lifesciences, ISO, Sop
Education
Case Western Reserve University
Bachelor of Science, Chemical Engineering
DLB Consulting Services, LLC February 2008 - Present
HMI Industries Inc. November 2014 - July 2015
TRN Technical October 2014 - November 2014
AxioMed Spine Corporation May 2011 - September 2014
Gebauer Company 2007 - 2008
ScottCare Corporation, div of Scott Fetzer, div of Berkshire Hathaway August 2005 - March 2007
ElectroSonics Medical Inc. May 2004 - August 2005
Beckman Coulter, Inc. February 1996 - April 2004
Mentor Corporation May 1994 - February 1996
Medtronic, Inc. February 1984 - May 1994
Skills
Regulatory Affairs, FDA, ISO 13485, Quality Systems, Medical Devices, Quality Assurance, Design of Experiments, Design Control, Process Validation, CAPA, Validation, Quality Management, FMEA, Quality Engineering, Six Sigma, Continuous Improvement, ISO 14971, cGMP, QSR, Compliance, GLP, Cross-functional Team..., Risk Management, Statistics, R&D, Document Management, SPC, Technical Writing, Program Management, Testing, Quality System, GMP, V&V, Product Development, Manufacturing, Quality Control, Regulatory Submissions, Quality Auditing, 21 CFR Part 11, Biomedical Engineering, Process Improvement, Computer System..., Process Simulation, GxP, Regulatory Requirements, 21 CFR, DMAIC, Lifesciences, ISO, Sop
Education
Case Western Reserve University
Bachelor of Science, Chemical Engineering
Molly Dahlgren Molly Dahlgren's AxioMed Spine Corporation Experience October 2005 - June 2008
Job Administrative Specialist Associate at University of Michigan
Industry Research
Experience
University of Michigan August 2014 - Present
The University of Michigan Health System April 2012 - August 2014
Center for Health Communications Research - University of Michigan March 2012 - April 2012
Sweetwater County School District #2 August 2009 - January 2012
Performance Overhead Door October 2008 - June 2009
AxioMed Spine Corporation October 2005 - June 2008
Liebherr Cranes Inc October 1997 - August 2005
Select Staffing Services September 1997 - October 1997
Holiday Inn May 1997 - August 1997
Holiday Inn May 1992 - May 1997
Skills
Travel Planning, Event Planning, Project Management, Teaching skills, Data Management, Budgeting and Cost..., Inventory, Public Relations, Computer Hardware..., HR Generalist Functions, Data Entry, Microsoft Office, PowerPoint, Confidentiality, Human Resources, Troubleshooting, Outlook, Teaching, Budgets, Training, Microsoft Excel, Visio, Customer Service, Office Management, Access, Spreadsheets, Administration
Education
Thomas Nelson Community College 1985 — 1987
AAS Degree, Office Technology
Youngstown State University 1981 — 1984
University of Michigan August 2014 - Present
The University of Michigan Health System April 2012 - August 2014
Center for Health Communications Research - University of Michigan March 2012 - April 2012
Sweetwater County School District #2 August 2009 - January 2012
Performance Overhead Door October 2008 - June 2009
AxioMed Spine Corporation October 2005 - June 2008
Liebherr Cranes Inc October 1997 - August 2005
Select Staffing Services September 1997 - October 1997
Holiday Inn May 1997 - August 1997
Holiday Inn May 1992 - May 1997
Skills
Travel Planning, Event Planning, Project Management, Teaching skills, Data Management, Budgeting and Cost..., Inventory, Public Relations, Computer Hardware..., HR Generalist Functions, Data Entry, Microsoft Office, PowerPoint, Confidentiality, Human Resources, Troubleshooting, Outlook, Teaching, Budgets, Training, Microsoft Excel, Visio, Customer Service, Office Management, Access, Spreadsheets, Administration
Education
Thomas Nelson Community College 1985 — 1987
AAS Degree, Office Technology
Youngstown State University 1981 — 1984
Tawny Bragg Tawny Bragg's AxioMed Spine Corporation Experience 2008 - 2009
Job Account Manager at Rockwell Automation
Industry Research
Experience
Rockwell Automation July 2011 - Present
BioEnterprise August 2010 - May 2011
The Cleveland Clinic 2009 - 2009
AxioMed Spine Corporation 2008 - 2009
Case Western Reserve University 2005 - 2007
Skills
Biomedical Engineering, Medical Devices, Commercialization, Data Analysis, Matlab, Market Research, Product Development, R&D, FDA, Project Management, Competitive Analysis, Entrepreneurship, Start-ups, Six Sigma, Strategy, Cross-functional Team..., Statistics, Process Engineering
Education
Weatherhead School of Management at Case Western Reserve University 2010 — 2011
MEM, Engineering and Management
Case Western Reserve University 2005 — 2010
BSE, Biomedical Engineering
Rockwell Automation July 2011 - Present
BioEnterprise August 2010 - May 2011
The Cleveland Clinic 2009 - 2009
AxioMed Spine Corporation 2008 - 2009
Case Western Reserve University 2005 - 2007
Skills
Biomedical Engineering, Medical Devices, Commercialization, Data Analysis, Matlab, Market Research, Product Development, R&D, FDA, Project Management, Competitive Analysis, Entrepreneurship, Start-ups, Six Sigma, Strategy, Cross-functional Team..., Statistics, Process Engineering
Education
Weatherhead School of Management at Case Western Reserve University 2010 — 2011
MEM, Engineering and Management
Case Western Reserve University 2005 — 2010
BSE, Biomedical Engineering
Christopher Wasco Christopher Wasco's AxioMed Spine Corporation Experience June 2012 - August 2012
Job Student at The Ohio State University
Industry Medical Devices
Experience
Navidea Biopharmaceuticals Limited June 2015 - Present
Ethicon Endo-Surgery May 2014 - August 2014
Ethicon, Inc. August 2013 - December 2013
Axiomed Spine Corporation June 2012 - August 2012
Skills
Matlab, SolidWorks, Biomedical Engineering, R&D, Testing, Simulations, Engineering, Medical Devices, Minitab, Design of Experiments, 3D Printing
Education
The Ohio State University 2011 — 2016
Bachelor of Applied Science (BASc), Biomedical/Medical Engineering, Senior
Padua Franciscan High School 2007 — 2011
Navidea Biopharmaceuticals Limited June 2015 - Present
Ethicon Endo-Surgery May 2014 - August 2014
Ethicon, Inc. August 2013 - December 2013
Axiomed Spine Corporation June 2012 - August 2012
Skills
Matlab, SolidWorks, Biomedical Engineering, R&D, Testing, Simulations, Engineering, Medical Devices, Minitab, Design of Experiments, 3D Printing
Education
The Ohio State University 2011 — 2016
Bachelor of Applied Science (BASc), Biomedical/Medical Engineering, Senior
Padua Franciscan High School 2007 — 2011
Ed Barber's AxioMed Spine Corporation Experience November 2011 - September 2014
Job VP of Product Development and Manufacturing at AxioMed LLC
Industry Medical Devices
Experience
AxioMed LLC 2015 - Present
AxioMed Spine Corporation November 2011 - September 2014
Axiomed Spine Corporation July 2008 - November 2011
NDI Medical January 2008 - July 2008
NDI Medical 2006 - 2008
PeriTec Biosciences 2005 - 2006
Cleveland Clinic 2004 - 2005
Skills
FDA, Medical Devices, Biomedical Engineering, R&D, ISO 13485, Surgical Instruments, Strategy, CAPA, Design Control, V&V, Tissue Engineering, Biomaterials, Cross-functional Team..., ISO 14971, Medical Imaging, Orthopedic, Product Development, Commercialization, Product Launch, Validation, Quality System, Spine, Clinical Trials, Lifesciences, Orthopedics, Life Sciences
Education
Case Western Reserve University
Biomedical Engineering - Biomechanics
AxioMed LLC 2015 - Present
AxioMed Spine Corporation November 2011 - September 2014
Axiomed Spine Corporation July 2008 - November 2011
NDI Medical January 2008 - July 2008
NDI Medical 2006 - 2008
PeriTec Biosciences 2005 - 2006
Cleveland Clinic 2004 - 2005
Skills
FDA, Medical Devices, Biomedical Engineering, R&D, ISO 13485, Surgical Instruments, Strategy, CAPA, Design Control, V&V, Tissue Engineering, Biomaterials, Cross-functional Team..., ISO 14971, Medical Imaging, Orthopedic, Product Development, Commercialization, Product Launch, Validation, Quality System, Spine, Clinical Trials, Lifesciences, Orthopedics, Life Sciences
Education
Case Western Reserve University
Biomedical Engineering - Biomechanics
Jude Shellito's AxioMed Spine Corporation Experience June 2011 - October 2014
Job Sr. Principal Engineer at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) December 2014 - Present
TRN Technical October 2014 - December 2014
AxioMed Spine Corporation June 2011 - October 2014
Norman Noble, Inc. March 1998 - June 2011
Acromed Corporation August 1993 - March 1998
DePuy AcroMed (formerly AcroMed) 1993 - 1998
TRW August 1985 - March 1993
Skills
Design Control, Medical Devices, V&V, ISO 13485, Iso 9000, CAPA, FDA, Cross-functional Team..., DMAIC, Biomedical Engineering, CQA, Quality Assurance, Process Improvement, Manufacturing, Six Sigma, 5S, Calibration, Continuous Improvement, Design of Experiments, FMEA, GMP, ISO, ISO 14971, Lean Manufacturing, Quality System, R, Root Cause Analysis, SPC, Validation
Education
Gannon University 1981 — 1985
BSMET, Engineering
Regulatory and Quality Solutions LLC (R&Q) December 2014 - Present
TRN Technical October 2014 - December 2014
AxioMed Spine Corporation June 2011 - October 2014
Norman Noble, Inc. March 1998 - June 2011
Acromed Corporation August 1993 - March 1998
DePuy AcroMed (formerly AcroMed) 1993 - 1998
TRW August 1985 - March 1993
Skills
Design Control, Medical Devices, V&V, ISO 13485, Iso 9000, CAPA, FDA, Cross-functional Team..., DMAIC, Biomedical Engineering, CQA, Quality Assurance, Process Improvement, Manufacturing, Six Sigma, 5S, Calibration, Continuous Improvement, Design of Experiments, FMEA, GMP, ISO, ISO 14971, Lean Manufacturing, Quality System, R, Root Cause Analysis, SPC, Validation
Education
Gannon University 1981 — 1985
BSMET, Engineering
Jerry Baty's AxioMed Spine Corporation Experience April 2008 - November 2014
Job Cheif Executive Officer at Safetech Aviation Safety Equipment
Industry Biotechnology
Experience
Safetech - Aviation Safety Equipment June 2015 - Present
GB Consulting & Strategy Development November 2014 - Present
AxioMed Spine Corporation April 2008 - November 2014
Mt. Cook July 2007 - May 2008
Transave Inc. 2003 - 2007
Genzyme 2000 - 2002
Texas Biotechnology 1995 - 2000
Skills
Business Strategy, Medical Devices, Project Management, Product Development, ISO 13485, Strategy, Strategic Planning, Finance, Mergers & Acquisitions, Start-ups, Venture Capital, Lifesciences, Pharmaceutical Industry, R&D, FDA, Cross-functional Team..., Healthcare, Biotechnology, Life Sciences, Investor Relations
Education
South Texas College of Law 1998 — 2002
Juris Doctor (J.D.), Corporate Law
University of Houston 1986 — 1988
Master of Business Administration (M.B.A.)
Stephen F. Austin State University 1982 — 1986
Bachelor's Degree, Accounting
Kingwood High School 1978 — 1982
High School
Safetech - Aviation Safety Equipment June 2015 - Present
GB Consulting & Strategy Development November 2014 - Present
AxioMed Spine Corporation April 2008 - November 2014
Mt. Cook July 2007 - May 2008
Transave Inc. 2003 - 2007
Genzyme 2000 - 2002
Texas Biotechnology 1995 - 2000
Skills
Business Strategy, Medical Devices, Project Management, Product Development, ISO 13485, Strategy, Strategic Planning, Finance, Mergers & Acquisitions, Start-ups, Venture Capital, Lifesciences, Pharmaceutical Industry, R&D, FDA, Cross-functional Team..., Healthcare, Biotechnology, Life Sciences, Investor Relations
Education
South Texas College of Law 1998 — 2002
Juris Doctor (J.D.), Corporate Law
University of Houston 1986 — 1988
Master of Business Administration (M.B.A.)
Stephen F. Austin State University 1982 — 1986
Bachelor's Degree, Accounting
Kingwood High School 1978 — 1982
High School
Deloitte
PwC
Ernst & Young
Walgreens
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EY