Senior Software Design Quality Assurance Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver technical assistance and direction to Software teams to guarantee adherence to software development procedures and relevant safety and quality regulations and standards.

• Assist in software design assurance for cloud-based, data platforms, and AI/ML-enabled systems.

• Offer practical guidance on IEC 62304, 21 CFR 820, and global regulations concerning SaaS, data, and AI-driven products.

• Lead the application, compliance, and ongoing enhancement of software development and validation methodologies.

• Manage pre-market risk management outputs, including Software Hazard Analysis, design FMEA, and risk control measures.

• Advise Software Design and Test teams on requirements traceability, software configuration management, tool validation, and integration of cloud/data services.

• Review and authorize software design control outputs.

• Assist in post-market activities related to software anomalies, model behavior, data quality concerns, risk evaluations, and CAPA.

• Create, review, and maintain Design History Files, SOPs, protocols, and reports.

• Evaluate infrastructure, data, and model change controls.

• Convey plans, progress, risks, and design assurance considerations to cross-functional teams and senior management.

• Collaborate with Software Engineering, Software Testing, Regulatory Affairs, Marketing, Project Management, Systems Engineering, Cybersecurity, and other departments.

⛳️ Requirements

• A Bachelor's degree in a technical field with 5–8 years of relevant experience, or a Master's degree with 2–5 years of equivalent industry experience, or a PhD with 0–2 years of experience.

• Extensive experience in software design assurance for cloud-based, data platforms, API, and service-oriented systems within a regulated environment.

• Practical knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485, and their relevance to software-as-a-service and data-driven products.

• Proficient in applying software design assurance principles throughout the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification.

• Experience in conducting and reviewing software risk management activities, such as Software Hazard Analysis (SHA), design FMEA, and change impact assessments for cloud, data, and AI/ML components.

• Skilled in reviewing and approving software design control outputs for traceability, risk control implementation, and regulatory adherence.

• Experience in supporting software configuration management, tool validation, and integrating cloud services, data pipelines, and platform components.

• Strong communication skills with cross-functional partners and senior leadership.

• AI/ML experience or ASQ CSQE certification is a plus.

• Willingness to travel 5–15% of the time.

🏝️ Benefits

• A comprehensive and extensive benefits package.

• Opportunities for growth on a global scale.

• Career advancement through in-house training programs and/or qualified tuition reimbursement.

• Home office arrangements for remote employees.

• Flexible workplace options may be available for employees within commuting distance of a Dexcom site.