Experience

• 

  The pennsylvania state university

  Sept 2005 - Aug 2006

  Research assistant

  Assisted professors and graduate students with mechanical heart valve research - cavitation studies related to heart valve closure and formation of stable bubbles, generation of blood analogs, and imaging of flow through heart valves using Particle Imaging Velocimetry (PIV).

• 

  Medrad

  Jan 2007 - Jan 2007

  Regulatory intern

  Design and Development - Assisted new product development on the flow profile of fluid through a catheter utilizing Particle Imaging Velocimetry (PIV).Regulatory - Arranged and organized Design History File, completed regulatory assessment against similar products, assisted new product development team on regulatory deliverables, and planned and executed initial steps for product approval in South Korea.

• 

  Regulatory and quality solutions llc (r&q)

  Jun 2008 - Sept 2018

  Program manager, business expansion initiatives

  Project manager and engineer serving medical device manufacturers, specializing in quality systems compliance, quality audits, design controls, process validation, site transfer, device registrations, project management, V&V testing, technical writing, and regulatory services.

• 

  Philips

  Sept 2018 - Jun 2023

  Lead the Quality PMO to complete key strategic improvement initiatives. Lead for new product development programs and projects within the sleep business group.

  • Head Of Program Management

    May 2022 - Jun 2023

  • Senior Project Manager

    Oct 2021 - May 2022

  • R&D Project Leader

    Sept 2018 - Nov 2021
• 

  Elle kaye studios llc

  Jun 2021 - now

  Co-owner and co-founder

  Family-owned and operated small business creating headwear, featuring our "hat bar" booth at local vendor shows east of Pittsburgh, PA. Find us at https://ellekayestudios.com

• 

  Sedgwick

  May 2023 - now

  Senior vice president, strategy management