Robert Calcote

Robert Calcote Email and Phone Number

Vice President, Operations & Compliance at Cardiac Dimensions @ Cardiac Dimensions
Robert Calcote's Location
Issaquah, Washington, United States, United States
Robert Calcote's Contact Details
About Robert Calcote

I am a medical device executive with over 43 years of manufacturing operations, product development, manufacturing engineering, quality system, and regulatory experience. In the last 36 years I have focused on the development and manufacturing of medical devices, including 23 years in vascular and cardiovascular, 9 years in orthopedics, and nearly 2 years in pain management. In the past 24 years I served as a vice president in 5 medical device companies and provided a variety of consulting services to 3 other medical device companies.I have contributed to key successes in a number of medical device start-ups, managed an international business unit through ISO and CE Mark certification, executed Class II and III regulatory submissions, performed M&A and partnership due diligence, reengineered entire quality systems, implemented new ERP systems, and provided technical expertise in several intellectual property lawsuits.Specialties: 
Start-up Companies, International Business Management, ERP/MRP Implementation, Supply Chain Management, Quality System Development, Regulatory Submissions, MDR, CER, Product Development (Stage-Gate, PDP), Acquisition and Partnership Due Diligence, Plant Transfers, Project Management, Process Development and Improvement, Expert Witness (IP), Six-SigmaFunctional Experience:Manufacturing, Materials Management, Strategic Sourcing, Quality, Regulatory (Class I, II & III), R&D, Manufacturing Engineering, Facilities Management, Multi-plant ManagementMedical Device Product Experience: 
Orthopedics: Cervical Disc & Lumbar Facet Implants, Custom Knee ImplantsVascular: ePTFE Vascular Grafts & Stent-Grafts, Polyester Vascular GraftsCardiovascular: Mitral Valve Repair, FMRPain Management: Electrotherapy, Spinal Bracing, Knee Bracing

Robert Calcote's Current Company Details
Cardiac Dimensions

Cardiac Dimensions

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Vice President, Operations & Compliance at Cardiac Dimensions
Robert Calcote Work Experience Details
  • Cardiac Dimensions
    Vice President, Operations And Compliance
    Cardiac Dimensions Apr 2014 - Present
    Kirkland, Wa, Us
    View
  • Medical Device Consulting
    Operations And Quality Systems Consultant
    Medical Device Consulting Jan 2013 - Apr 2014
  • Rs Medical
    Vice President, Operations
    Rs Medical Mar 2011 - Nov 2012
    Vancouver, Wa, Us
    View
  • Conformis
    Sr. Vice President, Operations
    Conformis Nov 2009 - Feb 2011
    Billerica, Ma, Us
    View
  • Archus Orthopedics
    Vice President, Operations
    Archus Orthopedics Dec 2004 - May 2009
  • Medtronic Spinal Dynamics
    Vice President, Operations
    Medtronic Spinal Dynamics 2000 - 2003
  • C. R. Bard (Impra)
    Director Of Manufacturing
    C. R. Bard (Impra) 1997 - 2000
  • Impra, Inc.
    Sr. Manager Operations/Manufacturing Manager
    Impra, Inc. Jul 1993 - Oct 1997
  • Impra, Inc.
    Assistant Engineering Manager/Engineering Supervisor
    Impra, Inc. Jan 1990 - Jul 1993
  • Impra, Inc.
    Production Engineer
    Impra, Inc. Jul 1988 - Jan 1990
  • Steelcase (Formerly Vecta)
    Contract Engineer
    Steelcase (Formerly Vecta) May 1986 - Jun 1988
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  • Steelcase (Formerly Vecta)
    Engineering Technician
    Steelcase (Formerly Vecta) Jan 1981 - May 1986
    View

Robert Calcote Skills

Orthopedic Medical Devices Quality System Product Development Iso 13485 Spine R&d Fda Design Control Knee Capa Cross Functional Team Leadership V&v Start Ups Design For Manufacturing Product Launch Manufacturing Biomedical Engineering Iso 14971 Operating Room Iso Biotechnology Market Development Surgical Instruments Capital Equipment Commercialization Lifesciences Surgeons Ultrasound Biomechanics Pharmaceutical Industry Clinical Trials Hardware Diagnostics Biomaterials Quality Assurance Six Sigma Surgery Manufacturing Engineering Gmp Fda Gmp Design Of Experiments Engineering Fmea Vascular Injection Molding Cardiology Validation Radiology 21 Cfr Part 11 Regulatory Affairs

Robert Calcote Education Details

  • The University Of Texas At Arlington
    The University Of Texas At Arlington
    Biomedical Engineering
  • The University Of Texas At Arlington
    The University Of Texas At Arlington
    Electrical Engineering

Frequently Asked Questions about Robert Calcote

What company does Robert Calcote work for?

Robert Calcote works for Cardiac Dimensions

What is Robert Calcote's role at the current company?

Robert Calcote's current role is Vice President, Operations & Compliance at Cardiac Dimensions.

What is Robert Calcote's email address?

Robert Calcote's email address is bc****@****cal.com

What is Robert Calcote's direct phone number?

Robert Calcote's direct phone number is +142560*****

What schools did Robert Calcote attend?

Robert Calcote attended The University Of Texas At Arlington, The University Of Texas At Arlington.

What skills is Robert Calcote known for?

Robert Calcote has skills like Orthopedic, Medical Devices, Quality System, Product Development, Iso 13485, Spine, R&d, Fda, Design Control, Knee, Capa, Cross Functional Team Leadership.

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