fda-21-cfr-part-820 jobs in San Diego

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.

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.

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.

Director of Software Engineering leading end-to-end delivery across customer-facing products and internal tooling at a life-sciences company. This role combines hands-on full-stack development (React, Go, AWS, Temporal) with team leadership, architecture ownership, and regulated software compliance (IEC 62304, ISO 13485, FDA 21 CFR Part 820).…See more Candidates should have 10+ years of software engineering with 3+ years managing teams, fluency with modern AI coding assistants, and experience shipping instrumentation, cloud SaaS, and ML/AI features.

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.