in-vitro-diagnostics jobs in San Diego

Associate Systems Engineer supporting the development and enhancement of in-vitro diagnostic (IVD) instruments within a regulated medical device environment. The role involves system integration testing, verification and validation (V&V) activities, troubleshooting, failure investigations, and risk assessments across multiple R&D projects.…See more Responsibilities include executing statistical analyses, performing root cause analysis, contributing to design control documentation and regulatory submissions, and collaborating with cross-functional teams (software, hardware, assay development, quality, manufacturing). Requires a Bachelor's degree in Systems Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering, or related field with 0–3 years of relevant experience; Master's preferred.

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.…See more 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.