

Results-driven Project Manager with a robust background in biomedical systems and engineering management, skilled in leading cross-functional teams within regulated healthcare environments. Proven expertise in project planning, risk mitigation, cost control, and process optimization ensures the delivery of compliant and efficient solutions. In-depth knowledge of ISO 13485 and FDA 21 CFR Part 820 quality systems facilitates navigation through complex regulatory landscapes. Committed to enhancing project performance and operational efficiency while fostering a positive, long-term impact on healthcare outcomes.
Proficient in Microsoft Office
Jira workflow optimization
SmartSheet
Patient flow management
3D mesh manipulation
Mat Lab, Python, SQL
Experience with SAP systems
GitHub
Tinker CAD
Solidworks
ISO 13485, FDA 21 CFR Part 820
Lean Six Sigma Green Belt
OSHA 30 Certification
Lean Six Sigma Green Belt
Massachusetts Institute of Technology XPro Drug and Medical Device Management