iso-13485 jobs in San Diego

Staff Software Engineer to own end-to-end LIMS (Laboratory Information Management System) implementation for a clinical/molecular diagnostics lab, connecting sample tracking to lab automation and instrumentation. Responsibilities include building the LIMS platform, creating integrations between LIMS and lab devices, modeling complex sample preparation and assay execution data chains, and ensuring compliance with 21 CFR Part 11.…See more Requires 7+ years of hands-on LIMS experience in clinical or molecular diagnostics, deep knowledge of sample-tracking data models for high-throughput workflows, full-stack programming across UI/APIs/backend, and regulated-environment expertise (21 CFR Part 11, ISO standards, CAP/CLIA). This is a hands-on technical leadership role requiring strong communication between lab scientists, automation engineers, and software teams.

Senior Software Engineer at Globus Medical responsible for full lifecycle management of medical device software products, from research and design through testing and delivery. The role requires strong full-stack development skills in .NET/C# backend and JavaScript/TypeScript frontend, with proficiency in Azure DevOps, Git, and web technologies including HTML5, CSS/SCSS, LitElement, and WebComponents.…See more Must follow FDA regulations, ISO 13485, and IEC 62304 standards in a regulated medical device environment, and perform some DevOps functions. Requires 8+ years of experience (or equivalent with advanced degree) in object-oriented design, Agile/TDD methodologies, and cross-functional collaboration with product management and engineering teams.

Senior Staff Software Outbound Technical Product Manager at Illumina responsible for owning product positioning, go-to-market strategy, and customer relationships for a portfolio of genomics and life sciences SaaS products. The role requires translating complex technical capabilities into customer-centric narratives, leading voice-of-customer efforts, and partnering with Engineering, Sales, and Marketing to align roadmap decisions with commercial impact.…See more The ideal candidate has 12+ years of product management experience, deep knowledge of genomics analysis software and cloud platforms for genomics data analysis, familiarity with FDA/ISO:13485 regulated environments, and the ability to influence product strategy across multiple platforms and cross-functional teams.

Senior D365 F&O Developer responsible for designing, developing, and supporting Microsoft Dynamics 365 Finance & Operations enhancements and extensions, with a focus on Manufacturing and Supply Chain modules in a validated life sciences environment. The role involves leading ERP implementation initiatives, AI-driven solutions (Copilot, AI Agents), system integrations with Salesforce, Azure, warehouse management systems, and eCommerce platforms, and managing D365 biannual release upgrades including testing and deployment.…See more Requires 3+ years of D365 F&O extension development experience and 5+ years managing cloud-based D365 ERP implementations, with strong expertise in X++, data entities, OData/REST APIs, and life sciences compliance (ISO 13485).

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.

Lead a medical-device iOS application as a senior engineer transitioning into engineering leadership. You'll own the architecture and technical direction of native Swift apps, device-to-cloud interfaces, and web services on GCP, while establishing CI/CD practices and collaborating with firmware and hardware teams.…See more The role requires proven experience shipping iOS/Swift products that integrate with medical devices and managing software end-to-end across mobile and backend platforms.

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.

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.

Global Support Engineer will provide Level 2/3 technical support for complex instrumentation in a biotech environment, diagnosing issues across mechanical, fluidics, optics, electronics, and firmware subsystems. The role includes triaging escalations, authoring technical documentation and service bulletins, supporting new product introductions, and serving as an on-site diagnostic resource to field service teams.…See more Requires a bachelor's degree in engineering and 2–5 years of field service or technical support experience in instrumentation or regulated biotech/medical device industries.

The Senior Scientific Platform Engineer will develop and maintain software components, data processing workflows, and platform services that operationalize scientific innovations for clinical studies. The role requires translating research outputs and algorithms into production-grade backend services, APIs, and data pipelines on AWS, while collaborating with Science, Data Science, Product, and Engineering teams.…See more The ideal candidate has 5+ years building analytics platforms or scientific computing solutions, strong Python proficiency, and experience with cloud-native and serverless architectures. The position demands the ability to understand complex scientific methods and transform them into scalable, validated, maintainable software solutions within a regulated healthcare environment.

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.

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.