Description
The Senior Systems Engineer owns system-level integration, requirements management, design verification, and technical leadership for complex electromechanical and fluidic instruments in in vitro diagnostic and human-use medical device programs. The role develops system architecture and requirements, manages traceability and verification strategies, supports FDA 510(k) and De Novo submissions, leads design reviews and risk analyses, and serves as the primary technical point of contact for clients and regulatory stakeholders. It requires a BS in a relevant engineering discipline, at least 8 years of systems engineering experience in IVD or human-use medical devices, and hands-on experience with FDA submissions and design controls. The position is on-site in San Diego and offers a salary of $150,000-$185,000 plus benefits, PTO, and a 401(k) with matching.
