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Proven experience developing, manufacturing, and delivering new products, business solutions and technology valued propositions and supporting existing products within medical devices & diagnostics.

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Extensive background in design and change control, statistics, strategic planning, process development, offshore outsourcing, OEM and vendor optimization, and Six Sigma design/process excellence tools.

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Resident Certified Six Sigma Blackbelt.

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Resident Certified Project Management Professional (PMP).

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Resident Certified Lead Assessor/Auditor.

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Out-of-the-box thinkers skilled in delivering first-of-a-kind solutions.

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Initiators of action who recognize limitations of the real world and strive to make possible tomorrow, what seemed impossible yesterday.

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Communicators of vision, thoughts, and ideas in a manner that produces great results.

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Agents of change who links business decision-making with technology decisions.

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Hands-on technologists with a passion for continually learning and leveraging new technology.

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Proactive leaders and consensus-builder skilled in communicating complex technology issues.

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Novel New Products Systems Development & Operations Leadership

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Rich experience in RFID, Devices, Diagnostics, Remote Connectivity products and systems.

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Introducer of numerous fully FDA/IVDD compliant medical devices & diagnostics products.

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Mentor in regulatory/compliance standards, cGxP, GAMP, ISO, EN, CE, UL, IVDD, IEEE 488.2, ASTM, AAMI, NCCLS/CLSI, CMMI, HIPAA, FDA 21 CFR Part 11/820/210-211.  Lead auditor.

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Leader of Global Operations and new products development teams through the complete project lifecycle.

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Example in determining the easiest way to comply with FDA/EU regulations proactively

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Leader in design control & design transfer with data-driven, & statistical input into manufacturing.

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Leader in performing extensive technological & technical assessments in process/product improvements.

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Innovated expedited development by employing simple & powerful approaches using risk-based solutions.

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Accelerated product rollout through cycle-time reduction and feature-based development.

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Managed complete development lifecycle, brand management, phased-launch, and launch of products.

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Reduced manufacturing costs through the implementation of lean manufacturing.

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Deployed a franchise model for software & systems development & releases to promote cooperation.

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Directed the integration and localization process in a multi-platform environment.

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Improved efficiency by implementing Design-for-Six-Sigma based Design and metrics system.