• Developed an Information Security Management Program (HITRUST), as the Lead Engineer, o Established organizational security requirements/specifications, o Authored Corporate Policies o Facilitated system testing through procedure development o Manage a million-dollar security budget• Managed third-party vendors through functional requirements,• Developed a Risk Management Program• Introduced project charters (i.e. a scope agreement between management and PMs) to drive accountability, traceability, and awareness, in an effort to achieve business results,• Established Kanban Board for project management (sprints), JIRA • Shared my team’s business metrics and project updates in weekly Leadership Townhall,• Implemented a Document Management System,• Developed a QMS task list and QMS Implementation project plan • Developed a common vocabulary which achieved better collaborations between cross-functional teams • Implemented automation to assist with limited staffing• Created financial forecasts and budgeting through analytical modeling• Produced a Design Study Review to analyze other products on market and how they obtained 510k breakthrough certification

• Lead Engineer for medical device certification (CE Mark) o ISO 14971• Authored Risk Benefit Analysis, resulting in justifications for deviations from Standards (channel disconnect, low battery escalation, AGW sound pressure level, MOOP vs. MOPP) o IEC 60601 (-1, -1-8, -2-24, -2-49, -2-55) • Wrote Test Procedures for IEC 60601 Single Fault Testing (syringe mechanism failure, sensor failure)• Oversaw system performance testing o IEC 62304 - defined software safety classification and software system risk assessments• Developed system testing matrix, which resulted in a 50% reduction in test time by identifying commonality between testing protocols• Composed a product Traceability Matrix organizing, user requirements, product risk and specification, with validation evidence

• Constructed a Standard Application Checklist, resulting in a Regulatory Compliance development plan roadmap• Developed compliance test plan and verification and validation procedures, resulting in consolidated alarm testing reducing the testing scope by over 50%• Composed a system test plan identifying testing types and compliance related tests, which highlighted essential performance requirements• Led requirements review meetings to coordinate functional teams, resulting in an assembly of cross-functional inputs• Organized design reviews to verify the system was ready for the next stages of development• Led Failure Investigation to discover our silicone supplier changed their manufacturing process • Utilized the KJ Method to organize customer needs and developed concise product requirements

• Led in the design, development and analysis of system requirements and system specifications for electrical systems.• Developed and maintained the feedback control software using C.• Developed system test procedures and performed all system test analysis using MatLab.• Created and prepared documentation for an auto-pilot.• Identified and resolved technical problems.• Managed all system level integration, test activities and test anomaly troubleshooting.• Evaluated system test data to validate design criteria.