iso-14971 jobs in San Diego

Senior Manager leading systems engineering for complex Point-of-Care diagnostic instruments, overseeing hardware, software, consumable, and assay integration. Responsible for system architecture, cross-functional integration with external partners, regulatory compliance (ISO 13485, IEC 62366, IEC 60601, ISO 14971), and risk analysis.…See more Will mentor junior engineers, drive technical decision-making across R&D, Quality, Manufacturing, and Regulatory teams, and manage the full product lifecycle from concept through commercial launch in a regulated environment.

This Staff QA Engineer role leads the design, development, validation, and deployment of Quality Assurance metric dashboards for manufacturing operations, with expertise in medical device quality management systems (QMS), regulatory compliance (FDA 21 CFR Part 11, ISO 13485), and non-conforming event management. The position coordinates site and corporate management reviews, participates in internal and external audits, and supports cross-functional teams in CAPA, risk management, and validation activities.…See more The engineer applies statistical analysis and dashboard tools (Power BI, Tableau, SQL, BigQuery) to drive quality decisions and operational excellence. Success requires direct experience with QMS, nonconforming materials, auditing, medical device regulations, and the ability to lead diverse functional groups in a fast-paced environment.

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 Quality Assurance Engineer role supports medical device product development and sustaining engineering teams by developing and implementing quality test procedures, test equipment protocols, and sampling plans. The engineer will conduct product investigations, corrective/preventive actions, regulatory submissions support, and statistical analysis of production data—all in compliance with industry standards (ISO 14971), GMP, and regulatory requirements.…See more The role requires 4+ years in medical device/pharmaceutical quality engineering or equivalent advanced degree with 2+ years of relevant experience, with expertise in test method validation, equipment qualification (IQ/OQ/PQ), risk management documentation, and analytical equipment validation.

Lead compliance testing and certification activities for a portfolio of medical devices, developing test strategies, managing external laboratories and certification bodies, and ensuring products meet FDA, safety, EMC, wireless, and regulatory requirements. Partner with Engineering, Quality, and Regulatory Affairs to identify compliance risks early and drive mitigation strategies.…See more Manage a team of compliance engineers and test professionals, oversee departmental budgets, and continuously improve compliance testing processes and best practices.