Project Coordinator Manager

Karen Hoover

**** ***** ****** ** *******, MN ***04 • 763-***-**** • ***********@*****.***

Experienced Project Specialist working in different project related roles within the Medical Device Industry. Worked and have been a senior member of a newly created PMO, and later worked under 2 other successful Fortune 500 Med Device Company PMO’s. Examples of the different role: Project Coordinator managing resources, managing team metrics, schedules, calendars using SharePoint, Excel, OneNote, PowerPoint. Partnered with vendors to come together to meet the customer’s needs. Project Manager managing large and small installations of patient monitors into MRI suites, networked defibrillators, and ventilators. Next, I moved into the manufacturing side of Med Device managing submission of med device new and sustained products to FDA and TuV. Program Manager Here I was brought in to work with a group focused on remediating documentation for approval under the new EU MDR regulations. I was able to build a team that consistently hit our milestones with consistently clean and accurate regulatory documents. I have enjoyed each of these roles and would be happy to work within a PMO at any level or take my experience and skills into something new. Experience

DEC 2020 – AUG 2023

PROGRAM MANAGER— Medtronic Fridley, MN

• Member of the Risk Management Team / Product Development

• Part of cross-functional teams including Manufacturing engineers, Quality, Regulatory,

• Worked with individual Project Teams to validate and assign Risk Resources, ensuring on-time delivery of Risk documents and required reviews of team documents to keep the overall project milestones on-track

• Kept a running view of the Risk teams current and forecasted resource usage. Highlighting teams’ success metrics. BI-Weekly status presentations to Directors including financials completed and forecasted.

• Responsible for presenting specifics of the Risk Engineers on-time delivery, and escalations.

• Ambassador for EUMDR Projects to the Larger Corporate team. JUN 2020 – OCT 2020

PROJECT MANAGER - Abbott Labs St. Paul, MN

• Worked with cross-functional teams to remediate regulatory documentation.

• Created summary review with full resource team breaking down review by dept (including product development), set timelines and set dependencies.

• The CE Mark Certificate that meets the EU MDR – Regulation (EU) 2017/745. JUN 2019 – APR 2020

PROJECT COORDINATOR - Boston Scientific Arden Hills, MN

• Create and Manage team and individual meetings. Created SharePoint to centralize team calendars and documents.

• Objective was to prepare new and updated products for Regulatory approval prior to manufacturing and distribution.

• Kept overall view of current projects and when the manufacturing teams should expect to have resources available for Engineering and Building tasks. OCT 2015 – JAN 2019

PROJECT MANAGER -Philips Healthcare Minneapolis, MN

• Collaborated with customers, internal employees, and third-party contractors to coordinate installs.

• Worked with new team members to integrate newly acquired companies.

• Created and Managed 5 Installation Teams across the US

• Developed tracking tools that analyzed the efficiency, consistency, and profitability of our projects.

• Conducted weekly team meetings to review project status, discuss issues that need attention including escalation. Confirm timeline, budget, scope changes, or product delays. JAN 2009 – OCT 2015

PROJECT MANAGER -Philips Healthcare Minneapolis, MN

• Facilitated team meetings to communicate workplace needs and overall progress.

• Documented team metrics, presented team progress monthly.

• Factory focal point for the factory for product holds/delays, change orders, new order confirmation making sure items will deliver to required delivery date.

• Managed relationships with vendors

Skills

Microsoft Suite (Advanced Excel, SharePoint, Word, Power Point, OneNote) • Proficient with project management software • Team Player • Excellent time management skills • Performance Monitoring • Public speaking • Data analytics • Business Process • Project Management

Education

EDUCATION

E COMPLETED MASTER'S CERTIFICATE IN PROJECT MANAGEMENT AND BUSINESS PROCESS ANALYSIS

— The George Washington University

Washington D.C., Mar 2016

COMPLETED BACHELOR OF SCIENCE IN BUSINESS MANAGEMENT

— University of Phoenix

Phoenix, AZ, Sep 2015

INTERNATIONAL STUDIES, PSYCHOLOGY

— State Cloud State University. St. Cloud, MN, Sept 2015

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