traceability jobs in San Diego

Senior software engineer role building autonomous cell-therapy manufacturing instrument software in a regulated environment. Responsibilities span instrument control software architecture, firmware-hardware integration, data pipeline management, CI/CD and SDLC practices, and regulatory documentation.…See more Requires 7+ years developing software for instruments, medical devices, or laboratory automation under regulated lifecycles, with strong C++, Rust, or Python, closed-loop control experience, state-machine architectures, and a safety-critical mindset.

This role supports the full product lifecycle for complex integrated systems, focusing on requirements management, system integration, verification & validation, and risk management. The Systems Engineer will conduct FMEA and hazard analysis, collaborate across software, electrical, mechanical, quality, and regulatory teams, and drive activities from concept through launch.…See more The position requires 3+ years of systems engineering experience, a bachelor's degree in engineering, and expertise in requirements traceability and risk assessment.

A junior System Integration & Test (SIT) Engineer role focused on validating embedded hardware and firmware across physical devices and embedded code. You will design and execute test procedures (bring-up, functional, regression), develop Python-based test automation scripts for hardware-in-the-loop testing, debug hardware/firmware issues using lab instrumentation, and interface with embedded communication protocols (UART, SPI, I2C).…See more You'll collaborate with firmware and hardware teams to reproduce and document defects, maintain test requirements and traceability, and support integration testing across hardware revisions and firmware builds.

This Systems Engineer role at a medical device company requires decomposing regulatory and stakeholder requirements into testable system specifications, leading design reviews and verification/validation activities, and supporting risk management under FDA and ISO frameworks. The position demands 2+ years in a regulated medical device environment, with responsibility for traceability documentation, design history files, failure investigation, and CAPA activities.…See more Key competencies include FDA design controls, ISO 14971 risk management, human factors/usability per FDA guidance, and cross-functional communication of complex system interfaces to diverse audiences.

Lead the full system development lifecycle for government programs, from requirements analysis and design through verification, validation, and sustainment. Manage requirements decomposition, allocation, and traceability; define system architecture and CONOPS using Model Based Systems Engineering (MBSE) methodologies; identify and mitigate technical risks associated with secure hardware; and produce comprehensive technical documentation.…See more Participate in customer meetings and technical interchanges; requires 12+ years of systems engineering experience, a Bachelor's degree in Systems Engineering or related field, and demonstrated expertise in requirements management, MBSE, the V-model, and Risk Management Framework (RMF) on medium-to-large DoD programs.