Dea Xhupi
Manufacturing Engineer @ Johnson & Johnson MedTech
United States
Boston
Higher Education
AutoCAD, Project Management, Kaizen Leadership, Corrective and Preventive Action (CAPA), pFMEA, Lean Manufacturing, Good Distribution Practice (GDP), MATLAB, SOLIDWORKS, C++, Arduino, 3D Slicer, Microsoft Excel, Leadership, Communication, Python (Programming Language), Public Speaking
Experience
Manufacturing Engineer
Johnson & Johnson MedTech
Danvers, MA
Production Engineering Co-op
Johnson & Johnson MedTech
Danvers, Massachusetts, United States
Production Engineering Co-op
Johnson & Johnson MedTech
Danvers, Massachusetts, United States
• Project Manager and Lead for cross-functional global FDA audit project; establishing and maintaining two global teams in Massachusetts and Germany, holding weekly review meetings, overseeing and executing all aspects of auditable documentation, compliance and project delivery • Aided in preparation of biomedical device FDA submission, ensuring adherence to regulatory guidelines, completion of GDP documentation and facilitating timely approvals • Ran weekly production engineering meetings with leadership, providing status updates, aligning teams on project goals, and issue resolution • Supported implementation of lean manufacturing principles; 5S methodology, 7 Wastes and Kaizen Programs
Education
Northeastern University
Bioengineering and Biomedical Engineering
Dea Xhupi's Contact Information
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