Agnes Ndamagye
Minneapolis,MN
Summary
Motivational leader and organizational problem-solver with advanced supervisory, team building and customer service skills. Experience stepping into roles and quickly making positive changes to drive company success. Focused on using results, training, and morale-building techniques to maximize employee engagement and performance.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Program Manager EUMDR
Ndamagye Consulting LLC. @ Integra Life Sciences
Minneapolis, MN
05.2022 - Current
- Manage EU MDR Remediation for 3 projects that total >3.5M in annual revenue for the CSS business. Responsible for program budgets and timelines, ensuring projects stayed on track and within allocated resources.
- Developed project plans, identified risks, set objectives and monitored progress towards completion.
- Coordinated with internal stakeholders to ensure successful implementation of the program initiatives.
- Drafted reports for senior management highlighting key milestones achieved throughout the program lifecycle.
- Collaborated with teams across departments to develop effective strategies for executing programs.
- Provided guidance and support to team members in order to achieve targets within defined deadlines.
Program Manager PMO
Medtronic
Minneapolis, MN
07.2021 - 05.2022
- Lead and developed packaging and labeling operations across three business units, including CRDN, SH, and Aortic, as EU MDR Program Manager
- Spearhead EU MDR submission, coordinating deficiency round and launch
- Oversee discussions for the UKCA project, steering implementation, and evaluation
- Orchestrate high-stakes discussions, identify and resolve substantive issues, negotiate win-win outcomes, mitigate risks, drive decision-making, and collaborate with team members
- Create and implement innovative improvement strategies, ensuring organizational prioritization and resource alignment
- Coordinate audit support and response, managing communications to achieve prompt review by subject matter experts
- Key Accomplishments: Streamlined preparation processes, enhancing program confidence and deliverables
- Demonstrated excellent verbal and written communication and an innate ability to think strategically and influence others without authority
- Effectively managed more than 20 programs with critical revenue implications
- Initiated a new strategy for China, increasing sales by over 20%.
People & Program Manager
Medtronic
Minneapolis, MN
08.2020 - 07.2021
- Oversaw resource planning across a team of six technical writers, leveraging bi-weekly team meetings and one-on-one interactions to develop foundational skills and introduce advanced techniques
- Opened and managed requisitions for new technical writers, coordinating talent acquisition to hire and onboard new staff members
- Utilized organization and prioritization skills, showcasing an ability to navigate multiple complex projects simultaneously
- Key Accomplishments: Increased institutional effectiveness, mentoring team members to align career goals and strengths with appropriate project assignments
- Spearheaded resource planning, managing translations budget totaling $1.5M
- Directed Annual Operating Planning (AOP), forecasting resource procurement to achieve programmatic success
- Routinely recognized for outstanding work in building diversity, equity, and inclusion standards.
Program Manager
Medtronic
Minneapolis, MN
09.2018 - 08.2020
- Coordinated support resource management for a team of ten technical writers leading new product development in CRHF
- Capitalized on a solid understanding of labeling requirements and tracing to IFU content
- Utilized optimal organization and prioritization skills and the ability to manage complex projects
- Key Accomplishments: Successfully led resource planning and management of translations budget valued at $1.5M
- Coordinated AOP planning and 6Q forecasting of CRM projects
- Oversaw launch of the most extensive program in CRM with 24 customer-facing numbers and two global configurations
- Contributed to the first leadless pacemaker program, spurring groundbreaking and exciting work.
Senior Labeling Project Manager
@ Medtronic (Select Source International)
Minneapolis, MN
06.2016 - 09.2018
- To achieve desired deliverables, directed planning, definition, and management of complex project scopes and timelines
- Communicated effectively with stakeholders and project teams, coordinating schedules and allocating resources to meet critical deliverables positively impacting business objectives
- Key Accomplishments: Efficiently partnered with cross-functional business associations, including Medtronic translations, regulatory, legal, packaging engineering, and marketing teams to outline strategic planning and execution
- Launched one of the most extensive programs in the Peripheral division, affecting every project in the portfolio
- Consistently delivered results within tight timelines and budget constraints.
Product Surveillance Specialist
Smith's Medical
Minneapolis, MN
02.2015 - 06.2016
- Engaged with clients, effectively communicating investigation results after partnering with internal quality, risk management, and legal teams
- Interfaced with organizational leadership, suppliers, and investigators to quickly and efficiently resolve product failures and disseminate critical information to all appropriate parties
- Key Accomplishments: Maximized efficiency by managing multiple priorities simultaneously to meet established client and business deadlines
- Led and guided numerous international product lines with high reportable incidents
- Effectively facilitated a 15% reduction in complaints backlog, assisting the team in conforming to FDA requirements and eliminating inconsistencies during audits
- Developed and incorporated updated methods of logging complaints.
Education
Bachelor of Science - Civil Engineering
University of Minnesota
Minneapolis, MN05-2004
Skills
- Program Management
- Project Management
- Organizational Leadership
- Medical Device Industry
- Process Improvement
- Quality Assurance
- Cross-Functional Collaboration
- Core Team Management
- Communication & Presentations
- Creative Problem Solving
- Scheduling & Logistics
- Resource Management
- P&L Management
- Partnership Development
- Enterprise Resource Planning
- Operations Management
- Program performance analysis
- Team Development
- Cost Management
- Strategic Planning
Certification
- Project Management Professional (PMP) Certification, 2018 - Present
- MDT - Lean Six Sigma DMAIC Problem Solving
- CAPA Management & Effectiveness Experience
- Leading with Emotional Intelligence
- Design Controls & Design Transfer
- Critical Thinking: Improve Your Thinking by Paying Attention to It
- Certified Product Management Professional (in Process)
Professional Involvement
- GLOW CO – Empowering Women to step into Greatness 2015 - Present
- Volunteer Leader in Production & New Member Experience, Creative Church, 2015 - Present
- Program Manager - Medtronic Muslims & Friends ERG, 2018 - May 2022
- Active Member, Medtronic ADN Employee Resource Group, 2017 - May 2022
- Vice President, Ugandan Association of Minnesota, 2019 - 2020
- Program Manager - PMI-MN, 2018 - 2019
Timeline
Program Manager EUMDR
Ndamagye Consulting LLC. @ Integra Life Sciences
05.2022 - Current
Program Manager PMO
Medtronic
07.2021 - 05.2022
People & Program Manager
Medtronic
08.2020 - 07.2021
Program Manager
Medtronic
09.2018 - 08.2020
Senior Labeling Project Manager
@ Medtronic (Select Source International)
06.2016 - 09.2018
Product Surveillance Specialist
Smith's Medical
02.2015 - 06.2016
Bachelor of Science - Civil Engineering
University of Minnesota
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