Blaze Bird

• Supported novel device through regulatory submissions, including FDA 501(k) submission for Type III medical devices and CE mark applications • Lead cross-functional project teams to ensure successful completion of six (6) compliance-related projects, including planning, executing, monitoring, and closing activities • Coached and mentored junior team members, providing guidance and support to foster professional growth and development.

• Ensure compliance with industry standards, including IEC 60601-1 and EU MDR, by collaborating with engineers, identifying necessary fixtures and equipment, and providing design inputs • Worked collaboratively within cross-functional project teams, considering project-wide impacts. • Conducted research to test and analyze feasibility, design, operation and performance of equipment, components, and systems.

• Automated 50% of test coverage for product and provided test coverage analysis of existing tests. • Collaborated with QA team to complete 100% of manual and automated test suite for Regulatory Submission. • Create and maintain knowledge base and test plan for novel product features.