iso-13485 jobs in San Diego

Lead iOS Software Engineer for a medical device startup, responsible for owning iOS application architecture and technical direction using Swift, designing native iOS apps, developing web services and device-to-cloud interfaces (preferably on GCP), and establishing CI/CD pipelines and engineering standards. You'll collaborate across firmware, hardware, and backend teams while conducting code reviews and ensuring security and maintainability.…See more The role combines senior individual contributor technical ownership with a path toward broader engineering leadership as the team scales.

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.

Senior Embedded Firmware Engineer responsible for designing, developing, and maintaining embedded software for medical and life-science products. You will contribute to firmware architecture, hardware/software interface definition, and participate in code reviews, testing, and design reviews while working with multidisciplinary teams.…See more The role requires strong embedded C/C++ proficiency, experience with formal software development processes, and hands-on debugging across real hardware systems. You'll also provide technical mentorship and help improve software engineering practices within Agile environments.

Quality Assurance Engineer responsible for implementing, maintaining, and improving quality management systems (ISO 9001, ISO 14001, ISO 13485, AS9100, Nadcap) in a manufacturing environment. The role involves developing work instructions, managing compliance documentation, conducting customer audits, and driving corrective action initiatives.…See more Requires 2+ years manufacturing experience (or 6+ years without a degree), proficiency with statistical analysis software, SAP, and the ability to interpret engineering drawings and GD&T. May supervise QA technicians and must be eligible to work in an ITAR environment.

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.

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.

Sr. Research Associate will design and execute design-of-experiments (DOEs) to optimize surface chemistry processes for in vitro diagnostic systems, transitioning formulations from R&D through pilot scale-up and manufacturing under GMP/FDA design control.…See more The role requires hands-on expertise in fluorescence imaging/spectroscopy, microfluidics, molecular biology techniques (nucleic acid extraction, PCR, amplification), and consumable characterization—including test method design, acceptance criteria definition, and root-cause analysis. The candidate will author technical documentation (protocols, batch records, DHF submissions), collaborate cross-functionally with assay development, reagent chemistry, device engineering, manufacturing, and quality/regulatory teams, and support FDA submissions (510(k)/PMA, CE-IVDR). Strong systematic troubleshooting, laboratory skills, and ability to present data to leadership are essential.

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.

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.

Senior Automation Engineer responsible for investigating equipment and process performance, optimizing designs and fixture systems, and managing capital planning for automation investments. Will lead end-to-end automation projects from requirements through FAT/SAT/deployment, specify and qualify manufacturing equipment, and drive the transfer of processes from R&D to production at scale.…See more Requires 8–12 years' experience in automated manufacturing systems, design of experiments, statistical analysis, and regulatory compliance (FDA 21 CFR Part 820, ISO 13485), with hands-on expertise in PLC/HMI, robotics, machine vision, and equipment integration.

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.

Lead iOS (Swift) Software Engineer for a medical device startup, owning architecture and technical direction for native iOS applications and device-to-cloud interfaces. You'll design and build iOS apps in Swift, develop web services on GCP, lead software decisions across mobile/backend/system integrations, and collaborate with firmware and hardware teams.…See more The role combines senior individual contributor responsibilities with growing engineering leadership as the team scales, including establishing CI/CD pipelines, code review standards, and security best practices.

Senior D365 IT Business Systems Analyst supporting the configuration, implementation, and ongoing maintenance of a Microsoft Dynamics 365 ERP system focused on Manufacturing and Supply Chain functions. The role involves liaising with business departments (Inventory, Manufacturing, Planning, QA/QC, Purchasing), analyzing requirements, configuring solutions, managing data quality, and coordinating testing and change management across a highly integrated system.…See more Requires 3–5 years of ERP implementation experience (D365, Oracle, or SAP) and strong cross-functional communication skills to bridge technical, business, and vendor teams.

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.

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 Software Release Manager owns end-to-end release planning, execution, and risk management for complex medical device software. The role requires technical understanding of system architecture and integration points to assess progress and anticipate risks, while coordinating across engineering, quality, regulatory, and product teams.…See more Responsibilities include managing schedules, budgets, vendor relationships, and ensuring compliance with FDA, ISO 13485, and IEC 62304 standards. The candidate will champion Agile and DevOps best practices, provide data-driven status reporting, and coach teams in hybrid Scrum environments.

This is a senior full-stack engineer role responsible for architecting and building internal platforms and cloud infrastructure that serve operations, finance, lab, and external customers. The engineer will design data models and APIs connecting lab systems, business software (NetSuite, ATS, CRM), and internal dashboards; build robust cloud infrastructure managing provisioning, cost, reliability, and security; and set technical direction on architecture, code quality, CI/CD, and observability across a growing engineering org.…See more The role requires 10+ years of full-stack production experience, deep hands-on cloud infrastructure knowledge, modern frontend (React) and backend skills, and ability to work directly with non-engineering stakeholders to translate ambiguous business requirements into shipped software. Over time, the engineer will build and mentor a team.

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.

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.

Quality Assurance Specialist II leads and supports audit activities, serves as a QA subject matter expert during inspections, and manages quality events and risk assessments for medical device products. The role involves conducting root cause analyses, managing document control and training workflows, coordinating the internal audit program, and driving quality-system improvement projects.…See more The position requires a bachelor's degree in a scientific or engineering discipline with 3–5 years of QA or regulatory affairs experience in a regulated industry, with medical device experience highly preferred. Key responsibilities include compliance with ISO 13485 and 21 CFR Part 820, partnership with senior quality engineers on risk management, and eQMS implementation and validation.

Lead iOS/Swift Software Engineer for a medical device startup, responsible for owning architecture and technical direction of native iOS applications and device-to-cloud interfaces. You'll design and build Swift-based apps, develop web services (preferably on GCP), lead cross-functional collaboration with firmware and hardware teams, and establish engineering best practices including CI/CD pipelines and security standards.…See more The role combines senior individual-contributor technical ownership with a path toward broader engineering leadership as the team scales.

Director-level role leading a software engineering team at a life sciences company building multi-omic analysis platforms. Requires hands-on full-stack expertise (React, Go, AWS, Temporal) alongside team management, architecture ownership, and end-to-end product delivery.…See more Must drive regulated software compliance (IEC 62304, ISO 13485, FDA 21 CFR Part 820), design controls, and V&V documentation while prototyping with AI tools and scaling agentic workflows within the team.