design-history-files 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.

Systems Engineer responsible for translating market and user needs into clear requirements across biology, hardware, and software subsystems at an early-stage cell-therapy manufacturing startup. Owns requirements management, interface control documentation, and system block diagrams to keep multiple engineering teams aligned during prototype development.…See more Leads verification, validation, and risk analysis planning; supports design reviews and regulatory compliance through design history file maintenance. Expects hands-on involvement in prototype assembly, testing, and cross-disciplinary problem-solving in a research-to-product transition environment.

This Systems Engineer role owns the requirements, interfaces, and risk management for an early-stage cell-therapy manufacturing platform spanning hardware, software, and biology. You will maintain requirements in dedicated tools, define and document interfaces between mechanical, electrical, fluidic, software, and cell-biology subsystems, support verification and validation planning, and coordinate across multiple engineering teams.…See more The role requires 5+ years at the intersection of biology, chemistry, and instrumentation, with hands-on lab experience and proven ability to run design reviews and resolve cross-team conflicts.

This Software Design QA Engineer role focuses on ensuring software development conformance to FDA, IEC 62304, and ISO 13485 standards in a medical device company. The engineer will lead design assurance activities including risk management (SHA, design FMEA), design control reviews, configuration management, and post-market compliance support.…See more The role requires expertise in medical device software development lifecycle processes, regulatory frameworks, and cross-functional collaboration with engineering, test, and regulatory teams.