design-control jobs in San Diego

Senior Staff Software Engineer leading technical strategy and architecture for embedded, connected medical-device software. Will resolve cross-functional technical issues spanning software, hardware, systems, and quality; identify architectural improvements and technical debt; mentor engineers; and drive design reviews and coding standards.…See more Requires 12+ years of professional software development with medical-device or regulated systems experience, proficiency in C/C++, embedded Linux/RTOS, and network-connected device design.

Staff QA Engineer role at Dexcom leading quality engineering for high-volume manufacturing automation, design control, and process validation. Responsibilities include interpreting FDA 21 CFR 820 and ISO 13485 requirements, architecting validation strategies, driving design transfer for commercial deployment, leading complex investigations and CAPA initiatives, and mentoring cross-functional teams.…See more Requires deep expertise in root cause analysis, Six Sigma, process validation, statistical analysis, and data-driven decision-making across global sites.

Staff QA Engineer at Dexcom leading manufacturing quality engineering and design control for high-volume medical device automation. The role requires deep expertise in FDA 21 CFR 820 and ISO 13485 compliance, design transfer strategy, process validation, and CAPA/MRB leadership across global manufacturing sites.…See more You will mentor cross-functional teams, drive systemic quality improvements, and represent the organization during regulatory inspections, with strong emphasis on data-driven decision-making and risk-based design methodologies.

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.

Lead a team of Quality Engineers supporting high-volume manufacturing automation, product introductions, and process validation across multiple programs and sites at a regulated medical-device company. Establish strategic direction for quality engineering, Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities while partnering with Engineering, Operations, and R&D to identify and mitigate risks.…See more Drive continuous improvement through quality metrics, CAPA effectiveness, and nonconformance management, and represent Quality Engineering during audits and regulatory inspections. Manage departmental resources, budgets, and staffing while building and developing high-performing teams.

Associate Systems Engineer supporting the development and enhancement of in-vitro diagnostic (IVD) instruments within a regulated medical device environment. The role involves system integration testing, verification and validation (V&V) activities, troubleshooting, failure investigations, and risk assessments across multiple R&D projects.…See more Responsibilities include executing statistical analyses, performing root cause analysis, contributing to design control documentation and regulatory submissions, and collaborating with cross-functional teams (software, hardware, assay development, quality, manufacturing). Requires a Bachelor's degree in Systems Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering, or related field with 0–3 years of relevant experience; Master's preferred.

Staff Quality Engineer for a medical device manufacturer responsible for owning and continuously improving the Quality Management System across the full product lifecycle. The role involves coordinating QMS processes and documentation, leading design control programs, managing change control reviews, directing CAPA activities, handling complaints and supplier qualification, and leading internal audit programs.…See more Requires 8–10+ years of medical device quality experience, 3+ years in quality system auditing, and strong expertise in ISO quality systems and FDA-regulated device standards.

Senior Staff Software Engineer leading technical strategy and problem-solving across software, systems, electrical, and quality functions for regulated medical-device products. Responsible for architecting embedded, connected, network-enabled systems; resolving cross-functional technical challenges; mentoring engineers; and ensuring compliance with FDA, IVDR, and international regulatory standards.…See more Requires 12+ years of professional software development experience with embedded or software-intensive products, deep proficiency in C/C++, embedded Linux or RTOS, and proven expertise in networked device design, secure communications, and design-control processes for medical devices or safety-critical systems.

Lead the architecture and technical strategy for a next-generation Class III implantable medical device, owning software design across embedded firmware, mobile, web, and cloud infrastructure. Establish architecture frameworks, design principles, and coding standards while translating clinical, regulatory, and business requirements into IEC 62304–compliant, FDA PMA–ready solutions.…See more Drive technical decision-making, conduct architecture reviews, and mentor a software engineering team across multiple domains. Support FDA submissions, design control activities, and cybersecurity integration throughout the system.

As Senior Staff Quality Engineer at Dexcom, you will drive quality compliance and inspection readiness across products, processes, and systems in a medical device environment. You'll lead complex investigations, implement corrective and preventive actions, mentor engineers, and ensure adherence to FDA 21 CFR 820 and ISO 13485 requirements.…See more The role requires hands-on expertise in QMS frameworks, design control, regulatory inspections, and the ability to influence stakeholders across engineering, operations, and global sites to maintain continuous audit readiness.

Lead the technical architecture and evolution of the ReActiv8 implantable medical device system across embedded firmware, mobile, web, and cloud infrastructure. Define software architecture strategies, translate clinical and regulatory requirements into compliant designs per IEC 62304 and FDA expectations, and establish coding standards and design principles for the engineering team.…See more Drive architecture reviews, design control activities, hazard analysis, and FDA regulatory submissions while mentoring software engineers across firmware, application, and cloud domains. Maintain development tools and practices including Azure DevOps, Git, and AI-assisted workflows in a regulated medical device context.

Staff QA Engineer at Dexcom leading manufacturing quality and regulatory compliance for continuous glucose monitoring devices. Responsibilities include directing Design Control and design transfer strategy, managing process validation and commercialization, leading cross-functional teams on complex technical and compliance matters, and providing expert guidance on Quality Management System governance (FMEA, CAPA, process controls).…See more Requires deep hands-on experience with FDA 21 CFR 820, ISO 13485, and related QMS requirements, plus ability to mentor teams and represent the organization during audits and regulatory inspections.

The Principal Software Engineer leads architecture and technical strategy for a Class III active implantable medical device, overseeing embedded firmware, mobile, web, and cloud systems. The role requires translating clinical, regulatory (IEC 62304, FDA PMA), and business needs into compliant, scalable designs while establishing architecture frameworks, design principles, and coding standards for the engineering team.…See more Responsibilities include leading architecture reviews, design control activities, hazard analysis, verification strategy, and mentoring across firmware, application, and cloud domains. The position demands 15+ years of software engineering with 8+ years in regulated medical device environments, hands-on expertise in .NET/C#/Blazor, Azure services, embedded firmware, cross-domain system integration, and strong cybersecurity practices for connected implantable devices.