iso-14971 jobs in San Diego

The Software Design QA Engineer 2 provides technical oversight and guidance to software development teams to ensure compliance with medical device regulations (IEC 62304, 21 CFR 820, ISO 13485, ISO 14971) and quality standards. Responsibilities include leading design assurance activities, reviewing and approving design control deliverables, managing pre-market risk assessments (SHA, design FMEA, cybersecurity risk management), supporting configuration management and tool validations, and driving post-market activities including anomaly assessment and CAPA.…See more The role requires deep knowledge of FDA and international medical device regulations, SDLC processes, and software development methodologies (Agile, Waterfall), with cross-functional collaboration across engineering, test, regulatory, and project management teams.

Senior Systems Engineer responsible for defining and maintaining system-level architectures for complex medical devices, including interface control documentation across fluidic, mechanical, electronics, software, and human factors subsystems. The role involves modeling system behavior using functional modeling techniques (SysML, functional block diagrams, state machines), conducting trade studies, and validating architectural assumptions through testing and characterization.…See more Requires partnering with cross-functional engineering teams to ensure subsystem alignment, supporting design controls per 21 CFR 820.30 and ISO 13485, and mentoring engineers on systems thinking and interface definition. This is a hands-on role grounded in bench-top testing, data analysis, and evidence-based architectural decisions rather than paper-only work.

This role leads quality engineering strategy and operations for a medical device design center, overseeing compliance with FDA regulations (21 CFR 820, ISO 13485, ISO 14971) and managing a team of Quality Engineers. The manager develops and sustains quality management systems, executes quality initiatives, provides statistical and design-control expertise, and drives continuous improvement.…See more The position requires ten years of progressive QA experience in FDA-regulated industries, three years of direct management experience, and deep knowledge of design controls, risk management, and quality engineering methodologies.

Sr. Software QA Engineer responsible for ensuring medical device software products meet regulatory requirements and quality standards throughout the development lifecycle.…See more Reviews design control deliverables, risk management documentation, verification and validation activities, and software anomalies for compliance with FDA, ISO, and company procedures. Participates in design reviews, traceability analysis, CAPA investigations, and process improvement initiatives while supporting audits and regulatory inspections.

As a Senior Software QA Engineer at Dexcom, you will investigate postmarket software and device issues in collaboration with Regulatory, Quality, R&D, and Clinical teams, applying structured problem-solving and statistical analysis to identify root causes and drive corrective actions. You will develop and improve complaint investigation processes aligned with software risk management activities (hazard analysis, DFMEA, PFMEA, risk assessments) and ensure compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and other medical device regulations.…See more You will analyze product performance anomalies, cybersecurity vulnerabilities, and postmarket trends to conduct software-focused risk assessments, then communicate findings and recommendations to technical and non-technical stakeholders to inform decision-making. You will translate postmarket insights into actionable product improvements that enhance safety, reliability, user experience, and regulatory compliance.

Sr Product Surveillance Engineer responsible for investigating postmarket software and device issues, driving complaint investigation processes, and ensuring regulatory compliance for medical devices. The role requires deep understanding of Dexcom's software architecture to evaluate product performance, apply structured problem-solving and statistical analysis to root-cause investigations, and communicate findings to technical and non-technical stakeholders.…See more You will support quality system activities (CAPA, HHEs), conduct software risk assessments, and partner with product and quality teams to translate postmarket insights into product improvements. Success requires demonstrated knowledge of FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and medical device quality systems.

Sr Staff QA Engineer at Dexcom leading Design Quality Engineering for material characterization, formulation science, and material-related risk management across product lifecycle. Responsibilities include establishing traceability between material attributes and device performance, leading qualification strategies for polymers, enzymes, reagents, adhesives, coatings, and membranes, applying ISO 14971 risk management, and partnering with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs.…See more Requires 8+ years in medical device, pharmaceutical, biotechnology, or combination product development with deep expertise in material characterization, analytical chemistry, and formulation development.

Sr Staff QA Engineer at Dexcom leads Design Quality Engineering for material characterization, formulation science, and material-related risk management across product development and lifecycle management. The role requires deep expertise in characterizing complex material systems (polymers, enzymes, reagents, adhesives, coatings, membranes) and establishing traceability between material attributes, manufacturing processes, and finished device safety/performance.…See more Responsibilities include driving risk-based decision making using ISO 14971, overseeing qualification strategies, partnering with R&D and regulatory teams, and representing Design Quality in design reviews, audits, and regulatory submissions. Requires 8+ years in medical device, pharmaceutical, or biotechnology quality engineering with demonstrated experience in material characterization and design control processes.

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.

Lead verification and validation of cloud-connected medical device systems, designing and executing comprehensive test plans while developing automated test frameworks in Python. Test Microsoft Azure cloud applications, APIs, and infrastructure alongside embedded medical device software in regulated environments.…See more Mentor other test engineers, support CI/CD pipelines, and perform root cause analysis on defects. Requires 10+ years in software testing/QA, deep Azure and Python expertise, hands-on embedded medical device testing experience, and SDLC/V&V process knowledge.

Sr. Director of Software Quality will build and lead Illumina's standalone Software Quality organization, establishing governance frameworks aligned with IEC 62304, ISO 13485, ISO 14971, and emerging AI Act requirements.…See more The role owns the Software Quality Management System across all software products, software-driven IVDs, and AI/ML-enabled diagnostics, embedding quality checkpoints throughout the product development lifecycle and post-market surveillance. Responsibilities include recruiting and developing a high-performing team, defining verification and validation standards, managing regulatory compliance for FDA, EU MDR/IVDR, and other global bodies, and serving as the subject-matter expert in regulatory inspections. The candidate must have deep hands-on expertise in IEC 62304, SaMD classification frameworks, cybersecurity in QMS (IEC 81001-5-1), and demonstrated experience building and leading software quality functions in regulated medical device environments.

Lead Android Software Engineer responsible for designing, developing, and maintaining Android applications for medical devices using Kotlin. Own complex features end-to-end from requirements through implementation, verification, and post-market support, with emphasis on hardware communication via BLE and other protocols.…See more Collaborate with embedded, cloud, systems, quality, and regulatory teams to ensure software reliability in a regulated environment. Requires 7+ years of professional Android development, advanced Kotlin proficiency, strong architecture knowledge, and experience with automated testing and CI/CD workflows.

Senior Software Engineer responsible for architecting and implementing complex Android applications in Kotlin for medical devices, with emphasis on reliability, security, and regulatory compliance. The role involves collaborating with embedded and systems engineers to integrate Bluetooth Low Energy (BLE) and other communication protocols with medical device hardware, designing testable architectures, and ensuring compliance with medical device standards like IEC 62304 and FDA requirements.…See more Responsibilities include leading design reviews, conducting root-cause analysis on field issues, implementing comprehensive testing strategies, and maintaining technical documentation for regulated environments.

Senior Embedded Software Engineer responsible for developing complex real-time embedded systems for electroporation therapy delivery, including firmware, device drivers, middleware, embedded UI applications, and system-level software. The role requires 7+ years of embedded software development experience with modern C++, ARM Cortex-M processors, RTOS frameworks (ThreadX, FreeRTOS, etc.), and expertise in real-time control systems, closed-loop feedback, safety-critical software, and cybersecurity implementation.…See more Responsibilities span architecture design, hardware-software integration, verification and validation, CI/CD support, and cross-functional collaboration with electrical, mechanical, and regulatory teams. The candidate must demonstrate proficiency with embedded development tools, debugging hardware, IEC 62304/IEC 60601 compliance standards, and FDA cybersecurity guidance.

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.

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.

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.

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.