Senior Software Design Quality Assurance Engineer

Dexcom

. Provide technical support and guidance to Software teams to ensure conformance with software development processes and applicable safety and quality regulations and standards .

Posted 11/3/2026full-timeRemote • United StatesSenior💰 $95,900 - $159,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software design assurance for cloud-based and AI/ML-enabled systems, ensuring compliance with IEC 62304 and FDA regulations. Proficient in risk management practices, software configuration management, and effective communication with cross-functional teams.

Highest-signal resume keywords

Software Design AssuranceIEC 62304 ComplianceSoftware Hazard AnalysisRisk Management ActivitiesCloud-Based Systems

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Hard Skills

Software Design Assurance PrinciplesRequirements AnalysisArchitecture and Design ReviewsImplementation OversightIntegration and VerificationSoftware Configuration ManagementTool ValidationChange Impact AssessmentsDesign Control Deliverables ReviewData Pipeline Integration

Soft Skills

Effective CommunicationCross-Functional Collaboration

Certifications & Qualifications

ASQ CSQE Certification

Industry Keywords

FDA 21 CFR Part 820ISO 13485SaaSData-Driven ProductsRegulated EnvironmentContinuous ImprovementDesign History FilesSOPsProtocolsRisk Controls

Tech Stack

Tools & technologies

CloudCyber SecuritySDLC

About the role

Key responsibilities & impact

Provide technical support and guidance to Software teams to ensure conformance with software development processes and applicable safety and quality regulations and standards
Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems
Provide hands-on guidance on IEC 62304, 21 CFR 820, and global regulations for SaaS, data, and AI-driven products
Lead application, compliance, and continuous improvement of software development and validation practices
Drive pre-market risk management deliverables, including Software Hazard Analysis, design FMEA, and risk controls
Guide Software Design and Test teams on requirements traceability, software configuration management, tool validation, and cloud/data-service integration
Review and approve software design control deliverables
Support post-market activities involving software anomalies, model behavior, data quality issues, risk assessments, and CAPA
Author, review, and maintain Design History Files, SOPs, protocols, and reports
Assess infrastructure, data, and model change controls
Communicate plans, progress, risks, and design assurance considerations to cross-functional teams and senior leadership
Interface with Software Engineering, Software Test, Regulatory Affairs, Marketing, Project Management, Systems Engineering, Cybersecurity, and other groups

Requirements

What you’ll need

Bachelor's degree in a technical discipline and 5–8 years of related experience, or Master's degree and 2–5 years of equivalent industry experience, or PhD and 0–2 years of experience
Strong experience in software design assurance for cloud-based, data platform, API, and service-oriented systems in a regulated environment
Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485, and their application to software-as-a-service and data-driven products
Proficiency applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification
Experience performing and reviewing software risk management activities, including Software Hazard Analysis (SHA), design FMEA, and change impact assessments for cloud, data, and AI/ML components
Skill reviewing and approving software design control deliverables for traceability, risk control implementation, and regulatory compliance
Experience supporting software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components
Effective communication with cross-functional partners and senior leadership
AI/ML experience or ASQ CSQE certification is nice to have
Ability to travel 5–15%

Benefits

Comp & perks

A full and comprehensive benefits program
Growth opportunities on a global scale
Career development through in-house learning programs and/or qualified tuition reimbursement
Home office arrangement for remote employees
Flex workplace option may be available for employees within commuting distance of a Dexcom site