Experience

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  Meddev Consulting, Llc

  • Principal Consultant
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  MedDev Consulting, LLC

  • Redmond WA

  • Principal Consultant

    • 2016 - Present
    • Redmond WA

    Medical Device Consulting

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  Medtronic Diabetes

  • Northridge CA

  • Consultant

    • 2014 - 2016
    • Northridge CA

    Conducted a variety of high priority tactical projects related to regulatory compliance• Primary contributor in the creation of completely revised Design Controls SOPs aligned with cGMPs and ISO 13485 regulatory requirements• Author/Key contributor of Design Verification and Design Inputs templat...

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  Physio-Control, Inc.

  • Redmond, WA

  • Design Assurance, Sr. Engineering Manager

    • 2009 - 2014
    • Redmond, WA

    Provided overall leadership for the Design Assurance group.• Conduct department wide resource planning and management. Interfaced with product team leaders to ensure full support for product development initiatives as well as ongoing life cycle activities. Supported development of enterprise wide...

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  Physio-Control, Inc.

  • Hardware Verification Engineer - Contract

    • 2007 - 2008

    Hardware Design Verification Engineer, primarily responsible for creating test plans, protocols and reports for product design changes.• Reviewed product requirements specifications, engineering drawings and BOMs for design changes, conducted regression analysis, and authored statistically based verification plans.• Budgeted and scheduled internal and external test resources for execution of verification test plans.• Responsible for the management of a dedicated technician staff and the execution of verification test programs. Coordinated with engineering team members and program managers on test findings and resolution.• Interfaced with the operations group and coordinated the design transfer of design changes.

  • Quality Engineering Manager

    • 2005 - 2007

    Responsible for management of the Corrective and Preventive action (CAPA) quality subsystem of a 400 million dollar class II and III medical device manufacturer. Provided leadership, direction, and support for a team of 12 engineers and other cross functional team members. • Restructured the quality data trending process to create a risk based system for triaging issues for CAPA. Process was deemed as best in class practice by TUV.• Developed and mentored a staff of multi-disciplined engineers, including Quality, Electrical, Mechanical, and Software Engineers.• Restructured the CAPA process to align the depth of corrective and preventive actions with the risk presented, enhanced work flow management, and improved the quality of CAPA process deliverables. • Interfaced with external regulatory bodies during audits. Succinctly communicated data trending and CAPA processes, and demonstrated compliance via deliverable reviews.

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  Physio-Control, Inc.

  • Redmond WA

  • Product Development Manager

    • 2002 - 2004
    • Redmond WA

    Successfully led cross functional product development teams from the design planning phase through commercial release for the automated external defibrillator (AED) product lines. Consistently completed projects on time and within budget, while fully satisfying internal and external regulatory re...

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  Physio-Control, Inc.

  • Redmond, WA

  • Senior Reliability Engineer/ Quality Assurance Engineer

    • 1989 - 2001
    • Redmond, WA

    Core team member on numerous product development programs, with primary responsibility for hardware design verification. Participated in all phases of product development, from initial planning through commercial release and support.• Provided overall project leadership and coordination for all h...