Senior Software QA Engineer

Dexcom

. Provide guidance on IEC 62304, 21 CFR Part 820, and global regulatory compliance across software development activities .

Posted 10/27/2026full-timeRemote • California • United StatesSenior💰 $95,900 - $159,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software quality assurance and regulatory compliance within the medical device industry, with a strong focus on IEC 62304 and FDA 21 CFR Part 820. Proficient in leading software development processes, validation activities, and cross-functional collaboration to ensure high-quality embedded systems.

Highest-signal resume keywords

IEC 62304 ComplianceFDA 21 CFR Part 820Software Quality AssuranceEmbedded Systems DevelopmentRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software DevelopmentSoftware TestingRequirements AnalysisDesign ControlsVerification and Validation (V&V)Configuration ManagementSystem IntegrationRisk-Based TestingContinuous Integration/Continuous Deployment (CI/CD)Signal Processing

Tools & Technologies

Requirements Management ToolsJamaEmbedded Development EnvironmentsLab-Based Testing Environments

Certifications & Qualifications

ASQ Certified Software Quality Engineer (CSQE)

Industry Keywords

Medical DevicesRegulated IndustriesAgile MethodologyWaterfall MethodologyISO 13485Change ControlSoftware AnomaliesCorrective and Preventive Action (CAPA)

Tech Stack

Tools & technologies

RTOSSDLC

About the role

Key responsibilities & impact

Provide guidance on IEC 62304, 21 CFR Part 820, and global regulatory compliance across software development activities
Partner with firmware, algorithm, and cross-functional teams to deliver high-quality embedded medical-device software
Represent Software QA as a core team member throughout the product lifecycle
Lead and improve software development and validation processes
Provide guidance on software design, testing, configuration management, tool validation, and system integration
Lead and support pre-market and post-market risk management, including software anomalies, risk assessments, and CAPA
Participate in design reviews, requirements analysis, and cross-functional discussions
Contribute to verification and validation activities across the SDLC using risk-based testing strategies
Review and approve software design-control deliverables and author DHF artifacts, SOPs, protocols, and reports
Assess change-control impacts for continued product performance and compliance
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree in a technical discipline and 5-8 years related experience, or Master’s degree and 2-5 years equivalent industry experience, or PhD and 0-2 years experience
Experience in software quality or engineering across requirements analysis, design/development, product integration, and testing
Ability to interpret software design and code to verify accurate implementation of requirements
Hands-on experience in software development and/or software testing
Experience with embedded systems and firmware, including hardware/software integration and lab-based testing environments
Experience in regulated industries, preferably medical devices
Familiarity with design controls, V&V, and quality systems including FDA 21 CFR Part 820, IEC 62304, and ISO 13485
Knowledge of SDLC processes and Agile and Waterfall methodologies
Ability to support San Diego, CA (PST) business hours
ASQ Certified Software Quality Engineer (CSQE) certification (nice to have)
Experience with continuous glucose monitoring systems or wearable medical devices (nice to have)
Background in signal processing and algorithm-driven systems validation (nice to have)
Familiarity with RTOS and embedded development environments (nice to have)
Experience with CI/CD pipelines for embedded systems (nice to have)
Experience using requirements management tools such as Jama (nice to have)

Benefits

Comp & perks

A full and comprehensive benefits program
Growth opportunities on a global scale
Access to career development through in-house learning programs and/or qualified tuition reimbursement
An exciting and innovative, industry-leading organization committed to employees, customers, and communities
Home office workplace; hybrid Flex workplace option may be available for employees within commuting distance of a Dexcom site