fda 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.

Director-level role leading clinical data management across multiple development programs at a therapeutic company. Responsible for overseeing data management CROs and vendors, ensuring data quality and regulatory compliance, managing the clinical data lifecycle (database build, data review, reconciliation, lock), and leading cross-functional teams.…See more Requires 10+ years of clinical data management experience, deep knowledge of FDA/EMA/ICH-GCP requirements, CDISC standards, EDC systems, and demonstrated ability to manage complex global trials.

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.

Sr. Specialist overseeing quality assurance systems, records management, and compliance in a pharmaceutical/biotech GxP-regulated environment.…See more Responsibilities include managing electronic quality systems, processing controlled documents and SOPs, supporting inspections and audits, analyzing quality metrics and dashboards, leading process improvement initiatives, and mentoring junior staff. Requires a bachelor's degree with 4+ years of pharma/biotech QA experience (or master's with 2+), strong knowledge of FDA/ICH/GMP/GLP/GCP regulations, proficiency with QMS and LMS platforms, and demonstrated leadership and analytical capabilities.

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.

The Bioinformatics Test Engineer will design and execute comprehensive testing strategies for NGS (Next Generation Sequencing) data pipelines, including alignment, variant calling, and annotation workflows. Responsibilities include data validation, regression testing, automated test script development in Python, and collaboration with CI/CD pipelines and cloud-based systems.…See more The role requires deep knowledge of NGS file formats (FASTQ, BAM, VCF), proficiency in Python scripting, hands-on experience with Git and CI/CD tools, and familiarity with cloud platforms (AWS/GCP/Azure) to ensure data accuracy and pipeline reliability.

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.

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.

Bioinformatics QA role focused on designing and executing comprehensive testing, validation, and automation strategies for genomics pipelines and laboratory data platforms. Responsibilities include developing automated test suites in Python, validating NGS workflows (FASTQ, BAM, VCF), performing regression and data-validation testing, and collaborating with wet lab and dry lab teams to ensure scientific and technical correctness.…See more The role requires strong Python scripting, CI/CD pipeline experience, cloud platform familiarity (AWS/GCP/Azure), and working knowledge of genomics science fundamentals including sequencing concepts and LIMS integration.

Senior iOS Software Engineer responsible for designing, developing, and delivering high-quality Swift-based iOS applications and SDKs for medical device products. Requires 5+ years of software development experience and 3+ years of iOS-specific development.…See more Responsibilities include implementing unit and UI tests, mentoring developers, ensuring software quality and architectural consistency, and collaborating with cross-functional teams (product, UX, QA, scrum) in an Agile environment. Must follow design assurance SOPs and support compliance with FDA and HIPAA regulations.

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.