Systems Engineer
• Generated scripts and test procedures for acceptance testing of medical device manufacturing and product software to support both product launch and sustainment releases. • Created and updated design documentation in support of company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, including compliance with U.S. Food and Drug Administration (FDA) regulations.• Coordinated cross functionally with clinical engineering, human factors engineering and field representatives, to design an algorithm that evaluates a signal acquisition troubleshooting prototype. • Led cross functional reviews of software and system requirements to meet customer requirements, which included investigating and closing actions identified during the requirement reviews. • Led a junior engineer, contractor and technician through design verification for maintenance release containing application and hardware updates.• Generated and documented requirements for application software and firmware for medical devices. • Created JIRA tickets for issues found during in-sprint testing and ad-hoc testing.
