aami-tir57 jobs in San Diego

This role leads product security engineering for FDA-regulated medical devices (Class I/II) and their cloud-connected platforms. The engineer owns the full security lifecycle—threat modeling, risk assessments, security architecture, secure SDLC integration, and regulatory documentation—balancing patient safety, data protection, and FDA compliance.…See more Responsibilities span device and cloud security, vulnerability management, SBOM processes, and cross-functional collaboration with engineering, quality, and regulatory teams. Required: 5+ years cybersecurity experience, hands-on work with embedded/cloud/application security, FDA submission experience, and medical device development background.

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.

This Staff Engineer role owns and executes BD's product security lifecycle for FDA-regulated medical device dispensing systems and their cloud platforms. Key responsibilities include defining end-to-end security architecture, conducting threat modeling and risk assessments, implementing secure SDLC practices aligned to NIST/OWASP/BSIMM, managing SBOMs and vulnerability remediation, and ensuring regulatory compliance (IEC 62304, ISO 14971, FDA cybersecurity guidance).…See more The role requires 5+ years of cybersecurity experience with FDA Class I/II devices, hands-on expertise in embedded/cloud/application security, and the ability to balance security controls with usability while supporting FDA submissions.

This is a hands-on product security role focused on threat modeling and cybersecurity risk management for medical devices and SaMD platforms. You'll conduct security risk assessments, build FDA submission documentation (510(k) files, risk management files, SBOMs), review security architecture, and maintain risk and vulnerability management plans.…See more The role requires 5+ years of cybersecurity or product security experience, with strong preference for FDA documentation and regulated medical device background, and working knowledge of NIST frameworks, OWASP, and secure SDLC practices.