Greater Fort Wayne
Project Management professional with 15+ years of experience driving complex programs in medical device development, manufacturing, and compliance-regulated industries. Skilled at leading cross-functional teams, ensuring FDA/EU MDR regulatory compliance, and delivering measurable results in cost reduction, efficiency, and customer satisfaction. Recognized for translating technical requirements into actionable project plans, building strong supplier relationships, and ensuring projects are delivered on time, within budget, and to quality standards. Core Competencies: · Project & Program Management (Agile/Waterfall/Hybrid) · Regulatory & Compliance (FDA, EU MDR, ISO) · Risk, Quality & Vendor Management · PLM Tools (Windchill, Veeva Vault, Index) · Project Scheduling & Tracking (MS Project, SharePoint, Smartsheet, Excel) · Continuous Improvement & Cost Reduction · Stakeholder Engagement & Team Leadership
· Delivered 100+ Instructions for Use (IFUs) from inception to completion, ensuring compliance with EU MDR requirements. · Executed end-to-end change management (CRs/CNs) in Windchill PLM, maintaining 100% accuracy across material data. · Coordinated with Project Managers, Quality, Regulatory, Packaging, Medical Affairs, Engineering, IT, and external suppliers to meet project deliverables. · Negotiated supplier and translation vendor costs, reducing expenses by 15%. · Maintained project SharePoint site for Spine and Mitek projects, ensuring transparency and alignment across global teams.
· Led cross-functional teams for Navistar Defense and Navistar Corporation projects, ensuring on-time, compliant delivery. · Managed and documented Bills of Material (BOMs) to support manufacturing accuracy and regulatory compliance. · Revised Unigraphics NX drawings to meet specifications, preventing downstream production errors. · Served as primary customer contact, ensuring program requirements were met and issues were resolved proactively.
· Supported Core Team Leaders and Program Manager on an FDA/EU MDR remediation program. · Coordinated cross-functional meetings with medical writers, physicians, and internal stakeholders. · Monitored schedules, risks, and deliverables, ensuring 100% adherence to compliance timelines.
· Partnered with Program Manager and Workstream Leads to execute company-wide EU MDR remediation program. · Built project dashboards in SharePoint and PowerPoint, providing visibility for leadership decision-making. · Tracked schedules, manpower, and risks in MS Project, ensuring timely resolution of compliance issues.