Experience

• 

  Metromedia fiber network/abovenet

  Oct 1998 - Aug 2004

  It operations manager

  Directly managed all functions for the IT Operations department including the Desktop Support and Server Support groups. Management duties extended to 10 direct reports throughout the United States.

• 

  Medtronic

  Aug 2004 - May 2022

  I established and lead a Design Control-Compliance Office within the PMO championing best practices for product development process (PDP) execution and compliance and focusing on process guardianship, product development support, and leading PDP-related projects. The office delivers a PDP that is robust and compliant while being easily navigable and scalable. It is in use by over 50 new product development and large scale design change projects across multiple operational divisions for medical device design development. These procedures scale to serve projects with diverse requirements from class II guide catheters to class III implantables such as heart valves, combination pharma devices, and devices with software and programmable logic.I am passionate about training and have led the to development and execution of an outreach program that delivers cross-functional PDP and Design Control training to Core and Extended team members as well as a comprehensive on-boarding/coaching program for over 50 project managers within the PMO.I specialize in 21 CFR Part 820, ISO 13485, MDD/MDR, and other global regulations and standards. I am a key SME and coordinator in prepping and executing quality system inspections including MDSAP, MDR, pre- and post-market approval, and internal audit programs. Show less The primary creator, owner, and guardian of new product development, design control, and project realization processes including developing and facilitating ongoing PDP and Design Control training and workshops to hundreds of learners.I conceived and co-led a harmonization project to bring 3 divergent PDPs into alignment. This allowed the same process to be utilized across multiple operational divisions with various product types and enabled better predictability, resource porosity, and quality outcomes. The project included examining, harmonizing, extending, or inactivating over 1300 documents. Targeted training was provided to over 200 learners in addition to numerous coaching, outreach and stakeholder alignment sessions delivered throughout the 2-year timeline. Show less A Project Manager serving global cross-functional Core Teams through all phases of development from concept to commercialization for Class II and III medical devices for a variety of therapies including combination products. I implemented best practice project management tools such as project risk management, scope management, project scheduling and lessons learned methodologies. I also wrote project Design and Development Plans, ensured proper documentation of Design Review activities, and maintained Design History Files for my projects ensuring adherence to design control and compliance regulations. Show less

  • Senior Business Process Program Manager

    Jul 2021 - May 2022

  • Business Process Manager

    Jul 2016 - Feb 2022

  • Principal Project Manager

    Nov 2009 - Jul 2016

  • Sr. Project Manager

    Aug 2004 - Nov 2009
• 

  Bd

  May 2022 - now

  Led a team of key product development Business Process owners including Design Control, Risk Management, Change Control, Documentation Control, Product Security, and Computer Software Validation supporting multiple businesses and product lines.Crafted a multi-year strategy for remediation of core product development processes to aid in removing business consent decreeImplemented strategy for transforming product development processes to support newly upclassified medical devices

  • Associate Director, Product Development Processes

    May 2023 - now

  • Quality Business Process Owner, Design Control

    May 2022 - Oct 2023