Archus Orthopedics
Industry: Company
DescriptionFounded: 2001
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Archus Orthopedics Employees
Solta Valeant Pharmaceuticals Inc. BOTHELL, WA December 2013 - Present
FUJIFILM SonoSite, Inc. Bothell, Wa September 2013 - December 2013
Cardiac Dimensions April 2011 - November 2013
Medicis Technologies. Bothell.Wa December 2010 - April 2011
Microsugical Technology.Redmond.WA June 2009 - December 2010
Archus orthopedics January 2006 - June 2008
Cardiac. Dimensions Kirkland,WA June 2004 - July 2007
SPINAL Dynamics, Mercer Island,WA June 2001 - November 2002
Boston Scientific .Redmond.WA February 1990 - July 2001
Skills
Medical Devices, ISO 13485, FDA, Testing, R, GD, GMP, FDA GMP, Design Control, V, Quality Assurance
Education
Bellevue Community College 1998 — 2001
none
IPC-A-610
IDEA-SEAN, LLC 2014 - Present
Globus Medical July 2007 - February 2014
Archus Orthopedics April 2004 - July 2007
Synthes December 2001 - April 2004
Skills
Medical Devices, Surgical Instruments, Design Control, Fluent in Spanish and..., Spine, Capital Equipment, ISO 13485, Biomedical Engineering, Biomaterials, FDA, Orthopedic, Pro Engineer, FMEA, CAPA, Product Launch, Product Development, R&D, Cross-functional Team..., Engineering
Education
Drexel University 2002 — 2004
Master's Degree, Engineering/Industrial Management
Temple University 1992 — 1996
Bachelor's Degree, Mechanical Engineering
Baxter Healthcare May 2013 - Present
Baxter Healthcare November 2011 - May 2013
ApaTech January 2008 - September 2011
Archus Orthopedics 2004 - 2007
Biomet March 1991 - October 2004
Skills
Clinical Research, Regulatory Affairs, Medical Writing, Professional..., FDA, Spine, Clinical Development, Clinical Trials, Orthopedic, Technical Writing, Medical Devices, ISO 13485, Surgeons, Medical Affairs, Validation, CRO, CAPA, Biotechnology, Regulatory Submissions, Design Control, Biologics, V&V, Pharmaceutical Industry, CTMS, Oncology, Biomedical Engineering, GCP, Cardiology, Urology, Bone, Product Launch, Lifesciences, Commercialization, Neurology, Orthopedics, Surgery, Clinical Monitoring, Health Economics, Neurosurgery, Biopharmaceuticals, EDC, Pharmacovigilance, Diabetes, Life Sciences, Therapeutic Areas, GMP, ICH-GCP, Clinical Study Design
Education
Rutgers College of Pharmacy, Piscataway, N.J. 1972 — 1977
BS Pharmacy, Pharmacy
Montclair State University 1995 — 2000
Statistics, Mathematics
Boston Scientific September 2014 - Present
Bayer HealthCare February 2013 - August 2014
Pathway Medical Technologies November 2008 - February 2013
Archus Orthopedics April 2003 - October 2008
Medtronic Spinal Dynamics September 1998 - April 2003
University of Washington Applied Physics Laboratory February 1991 - September 1998
Skills
Medical Devices, Design Control, ISO 13485, Manufacturing, R&D, Solidworks, Product Development, Quality System, CAPA, Design for Manufacturing, FDA, V, Validation, Injection Molding, Design of Experiments, SolidWorks
Education
North Seattle College 1987 — 1989
AAS, Electro-Mechanical Packaging & Design
Intellectual Ventures Lab October 2011 - Present
Picker Technologies November 2009 - October 2011
John Ohrt Consulting May 2009 - October 2010
Archus Orthopedics March 2005 - May 2009
Stairmaster Sports Medical Products March 1992 - June 2002
Morse Industrial Corp./ Emerson Electric March 1983 - August 1990
Skills
Solidworks, Mechanical Engineering, CAD, R&D, GD&T, Medical Devices, FDA, Product Development, Manufacturing, Product Design, Design for Manufacturing, ISO 13485, Engineering, Patents, Cross-functional Team...
Education
Basalt High School
Mesa State College
EKOS Corporation, a BTG International group company June 2014 - Present
Strategian Consulting, LLC November 2013 - Present
Pathway Medical Technologies, A Bayer HealthCare Company June 2008 - September 2013
Archus Orthopedics May 2005 - June 2008
Northstar Neuroscience August 2003 - May 2005
Medtronic Spinal Dynamics 1999 - 2003
Skills
Medical Devices, Biotechnology, Pharmaceutical Industry, ISO 13485, FDA, ISO, Quality System, CAPA, Process Improvement, R&D, Product Development, Design Control, V&V, Lean Manufacturing, GMP, Cross-functional Team..., Contract Management, Procurement, Vendor Management..., Inventory Management, Inventory Analysis, Vendor Managed Inventory, Capital Equipment, Contract Manufacturing, Product Launch, Public Speaking, Negotiation, Corporate Partnership..., Six Sigma, Design for Manufacturing, FDA GMP, Strategy, Validation, Start-ups, Leadership, Supply Chain, SPC, Manufacturing, Orthopedic, Design of Experiments, Continuous Improvement, Manufacturing..., Root Cause Analysis, 21 CFR Part 11, Supplier Quality, 5S, Regulatory Affairs, Kaizen, Surgical Instruments, Injection Molding
Education
Seattle Pacific University
BA, Biology
Seattle Pacific University
BS, Biochemistry
Spinal Kinetics 2015 - Present
Stokes MedTech Solutions LLC 2012 - 2015
VertiFlex Inc 2009 - 2012
Archus Orthopedics 2006 - 2009
Zimmer Spine 2004 - 2006
Zimmer Spine 2002 - 2004
Spine-Tech 2000 - 2002
Zimmer 1999 - 2000
Brassler USA 1995 - 1998
Skills
Medical Devices, Product Launch, Market Development, Operating Room, FDA, Spine, Surgery, Surgeons, Capital Equipment, Orthopedic, Clinical Trials, Commercialization, Marketing Strategy, Start-ups, Neurosurgery, Product Management, Strategy, Healthcare, Hospitals, Surgical Instruments, Neurology, Lifesciences, Product Marketing, Marketing, Biomedical Engineering, Sales Operations, Disposables, Radiology, Sales Force Development
Education
University of Notre Dame - Mendoza College of Business
MBA, Marketing
Micronics September 2012 - Present
Gilead Sciences 2010 - December 2012
Archus Orthopedics 2004 - May 2009
Seattle Systems 2002 - 2004
NextRx 2000 - 2001
CSI 1999 - 2000
Spinal Dynamics 1998 - 1999
DePuy Orthopaedics 1993 - 1998
Skills
Product Development, Medical Devices, Design Control, Validation, Manufacturing, FDA, Testing, Manufacturing..., Solidworks, Engineering, Project Management, Program Management, R&D
Education
UW
Technology Management MBA
Purdue University 1990 — 1993
MSME, Mechanical Engineering
Virginia Polytechnic Institute and State University 1985 — 1990
BSME, Mechanical Engineering
Duft, Bornsen & Fettig, LLP February 2010 - Present
Townsend and Townsend and Crew 2009 - 2009
Oblon Spivak June 2008 - August 2008
Archus Orthopedics May 2006 - August 2006
Mayo Clinic June 2005 - August 2005
Advanced Process Combinatorics June 2004 - August 2004
Skills
Patents, Patentability, Trade Secrets, Patent Litigation, Intellectual Property, Licensing, Patent Prosecution, Biomedical Engineering, Trademarks, Algorithms
Education
University of Colorado Boulder 2007 — 2010
Juris Doctor
University of Colorado School of Law 2007 — 2010
JD, Technology and IP Law
Purdue University 2003 — 2007
BSBME, Biomedical Engineering
Intellectual Ventures August 2012 - Present
Kinetic Research and Design July 2012 - Present
Picker Technologies April 2008 - June 2012
Archus Orthopedics 2005 - 2008
Spinal Dynamics Corporation 1997 - 2005
Skills
Quality Assurance, Medical Devices, Solidworks, Design for Manufacturing, ISO 13485, R&D, Mechanical Engineering, SolidWorks, Product Development, Machining, Engineering, Design of Experiments, Design Control
Education
North Seattle Community College 1984 — 1986
Associate of Arts and Sciences (AAS), Electromechanical Package Design
ChoiceSpine February 2015 - Present
Medical Devices 2010 - Present
Alphatec Spine 2012 - 2014
Pioneer Surgical Technology 2009 - 2012
Archus Orthopedics 2004 - 2009
Spinal Concepts (acquired 2003 by Abbott Labs) 2000 - 2004
Skills
Strategic Planning, Medical Devices, Orthopedics, Spine, Biologics, Startups, MBA, Expert Witness, Consulting, New Business Development, Licensing, Acquisition Integration, Cross-functional Team..., Customer Service..., Clinical Trials, Global Strategy, Global Business..., Orthopedic, Product Development, Operating Room, Commercialization, Start-ups, Capital Equipment, Hospitals, Disposables, Surgeons, Product Marketing, Neurology, Surgery, Product Launch, Market Development, Healthcare, Neurosurgery, Surgical Instruments, Marketing, Biotechnology, Product Management, Sales Operations, Management, Strategy
Education
Northwestern University - Kellogg School of Management
MBA
The Ohio State University - The Max M. Fisher College of Business
B.S., Business Administration, Marketing
Medtronic Spinal and Biologics June 2014 - Present
Medtronic Spinal and Biologics November 2010 - June 2014
Medtronic Spinal and Biologics January 2009 - November 2010
Archus Orthopedics September 2004 - December 2008
University of Toledo August 2002 - August 2004
Skills
Finite Element Analysis, Biomechanics, Mechanical Testing, R&D, Spine, Biomedical Engineering, Biomaterials, Design Control, Medical Devices
Education
University of Toledo 2002 — 2004
M.S., Bioengineering
Osmania University 1998 — 2002
B.E., Biomedical Engineering
M9 Defense November 2011 - Present
Randall Mills Design 2000 - Present
Nilfisk-Advance, Hydramaster North America 2008 - 2011
Archus Orthopedics 2007 - 2008
Spiration, Inc. 2006 - 2007
Aegis Technologies 2004 - 2006
Tru-Circle Aerospace 2003 - 2004
Koszegi Industries 1995 - 2000
Physio-Control Corporation 1989 - 1994
Beckman Instruments 1981 - 1989
Skills
Industrial Design, CAD, Design Management, Concept Development, Prototyping, Machine Design, Advanced Vehicle..., SolidWorks, Product Design, Manufacturing, Solidworks, Sheet Metal, Solid Modeling, Rapid Prototyping, R&D, Design Thinking, Design for Manufacturing
Education
California State University-Long Beach 1977 — 1980
Bachelor of Science (BS), Industrial Design
Art Center College of Design 1976 — 1976
Attended Evening Extension Class
Bellevue Community College
Classes taken in Project Management, Web Databases Programming
RTI Surgical July 2013 - Present
Pioneer Surgical Technology February 2012 - July 2013
Pioneer Surgical Technology January 2010 - February 2012
Archus Orthopedics April 2007 - February 2009
DePuy Spine 2009 - 2009
Skills
Medical Devices, Product Launch, Product Development, Product Management, Product Marketing, Cross-functional Team..., Operating Room, Marketing Strategy, Disposables, Market Research, Surgical Instruments, Surgeons, Management, Orthopedic, Sales, Spine, Start-ups, Neurosurgery, Surgery, Orthopedics
Education
St. Edward's University 2011 — 2013
Army School of Health Sciences 2000 — 2000
Certification, Surgical Technology/Technologist
University of Maine 1998 — 2000
LINKSpine September 2014 - Present
LionCore, LLC Medical Device Consulting January 2014 - Present
Stryker Spine October 2009 - December 2013
Archus Orthopedics May 2002 - May 2009
Spinal Dynamics Corporation August 1998 - May 2002
Alphatec Manufacturing, Inc. July 1996 - May 1998
Smith & Nephew Orthopaedics 1991 - 1996
Skills
Medical Devices, R&D, Product Development, Orthopedic, Leadership, Spine, Management, Design Control, ISO 13485, Biomedical Engineering, FDA, Clinical Research, Materials, Commercialization, Biomaterials
Education
Cornell University 1985 — 1990
BSME, Mechanical/Biomechanical Engineering
Microsoft December 2012 - Present
SignalSet, Inc. May 2011 - August 2012
SignalSet, Inc May 2011 - August 2012
Dendreon August 2009 - May 2011
Dendreon 2009 - 2011
Archus Orthopedics March 2006 - February 2009
Archus Orthopedics 2006 - 2009
Veritas Financial Services, Inc June 2003 - March 2006
Sherrie Suits June 1993 - June 2000
Hair Masters September 1993 - May 1994
Education
University of Idaho 1991 — 1993
University of Idaho
General Studies