Summary

The Systems Engineer applies interdisciplinary expertise to define, develop, integrate, and test complex In Vitro Diagnostic systems for medical device applications. Responsibilities include documenting user and system requirements, decomposing system architecture into subsystems with defined interfaces, conducting hazard and risk analysis, managing configuration and change control, driving system integration and root-cause analysis, and supporting clinical validation. The role requires 10+ years of industry experience with demonstrated mastery of the full product development lifecycle in medical device or regulated environments, including risk management, design reviews, and cross-functional collaboration with development, testing, and clinical teams.