fda-compliance jobs in San Diego

This Bioinformatics Product Owner role focuses on defining and executing the product roadmap for NGS (next-generation sequencing) bioinformatics pipelines and supporting software in precision oncology. The role requires deep domain expertise in cancer genomics, NGS workflows (whole genome, exome, transcriptomics), and clinical genomics standards (FDA, CLIA, CAP, AMP), combined with product management skills to prioritize backlogs, lead Agile ceremonies, and coordinate across bioinformatics, engineering, clinical, and regulatory teams.…See more Key responsibilities include translating clinical and business needs into epics and user stories in JIRA, ensuring FDA compliance and computer system validation (CSV), and optimizing NGS pipeline performance. The ideal candidate brings proven product ownership experience in bioinformatics or oncology software, strong requirement-gathering abilities, and fluency in both technical NGS tools and regulatory frameworks.

Lead the testing strategy and execution for embedded medical device software, with responsibility for designing automation-ready test cases, implementing automated test suites, and ensuring compliance across instrument functionality, cloud connectivity, and system interoperability in an FDA-regulated environment. Author and execute test plans covering documented requirements, collaborate with engineering and quality teams, and maintain automated test frameworks using tools like Squish and Robot Framework.…See more Requires 7+ years of software testing experience, proficiency in Python scripting, embedded software testing expertise, and hands-on work in Linux-based environments with Agile development teams.

The Software Release Manager owns end-to-end release planning, execution, and risk management for complex medical device software. The role requires technical understanding of system architecture and integration points to assess progress and anticipate risks, while coordinating across engineering, quality, regulatory, and product teams.…See more Responsibilities include managing schedules, budgets, vendor relationships, and ensuring compliance with FDA, ISO 13485, and IEC 62304 standards. The candidate will champion Agile and DevOps best practices, provide data-driven status reporting, and coach teams in hybrid Scrum environments.

Quality Assurance Analyst II will process change orders and manage training in an electronic quality management system, ensuring compliance with work instructions and coordinating with cross-functional engineering teams. The role involves document control, record organization, logbook management, NCMR/CAPA investigation, and supplier management in a regulated medical device environment.…See more The candidate must demonstrate strong attention to detail, analytical problem-solving, and ability to communicate with multiple departments in a fast-paced setting. A bachelor's degree preferred with minimum 3 years in medical device/biotech quality document control in an FDA or ISO-regulated industry.

Sr. Systems Engineer at Globus Medical responsible for complex medical device system development, leading cross-functional coordination across software, hardware, clinical, regulatory, and manufacturing teams.…See more The role requires decomposing intricate systems, troubleshooting subsystem interactions, conducting risk analysis per ISO 14971, and driving continuous improvement through design of experiments and root cause analysis. Requires 5+ years in complex system development (medical devices, robotics, or similar) with strong systems engineering principles, FDA-regulated product development experience, and ability to translate technical concepts across multidisciplinary disciplines.

Design and implement security strategies for Abbott's cloud-based applications and medical devices, including hardening, incident response, penetration testing, and disaster recovery. Apply expertise in user authentication, certificate management, digital signatures, and cloud security architecture while ensuring compliance with ISO, FDA, and regulatory standards.…See more Leverage AI-assisted development tools and cybersecurity platforms to automate vulnerability analysis, evidence collection, and remediation tracking. Conduct hands-on web, mobile, and cloud infrastructure security testing using DAST, SAST, SCA, and vulnerability scanning tools, with demonstrated experience in product security and medical device environments preferred.

Design and develop security strategies for Abbott's cloud-based medical devices and applications, including hardening, incident response, penetration testing, and disaster recovery. Apply expertise in user authentication, certificate management, digital signatures, and cloud security architecture while ensuring compliance with ISO, FDA, and regulatory standards.…See more Conduct web, mobile, and cloud infrastructure security testing using DAST, SAST, SCA, and vulnerability scanning tools. Leverage AI-assisted development and cybersecurity tools—including building agentic AI applications—to automate security deliverables, with responsibility for evaluating AI tools for safe, policy-compliant use and mitigating AI/LLM-specific risks.

Staff Software Engineer responsible for leading macro-level technical design, architectural implementation, and development of critical embedded software subsystems in C++ and Qt. The role owns end-to-end software lifecycle deliverables, conducts architecture and design reviews, ensures FDA/IVDR regulatory compliance, and mentors junior engineers.…See more Requires 10+ years of professional experience with complex embedded systems, expert-level C/C++ proficiency, and mastery of object-oriented design and UML modeling.