Senior Software Design Assurance (Sr Software Design Quality) Engineer

The Senior Software Design Assurance Engineer at Dexcom supports software quality and regulatory compliance for cloud-based, data platform, and AI/ML-enabled systems in a leading health technology company.

Location: Remote

Salary: $95,900.00 - $159,900.00

Responsibilities

• Support software design assurance for cloud‑based, data platform, and AI/ML‑enabled systems.
• Provide technical guidance on IEC 62304, 21 CFR 820, and other regulations for software‑as‑a‑service, data, and AI‑driven products.
• Lead application, compliance, and improvement of software development and validation practices for distributed systems, cloud services, and data platforms.
• Drive pre‑market risk management activities including Software Hazard Analysis, design FMEA, and risk controls.
• Guide Software Design and Test teams on design assurance activities such as requirements traceability, configuration management, and tool validation.
• Review and approve software design control deliverables for cloud‑hosted services, data pipelines, and AI/ML components.
• Support post‑market activities related to software anomalies, model behavior, data quality issues, risk assessments, and CAPA.
• Author, review, and maintain technical documentation for cloud‑based and AI/ML‑enabled systems.
• Assess change control activities to ensure no adverse impact on product performance.
• Communicate plans, progress, risks, and considerations to teams and leadership.

Requirements

• 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 in applying software design assurance principles across the SDLC.
• Experience performing and reviewing software risk management activities including SHA, FMEA, and impact assessments.
• Experience reviewing and approving software design control deliverables.
• Support experience with software configuration management, tool validation, and integration of cloud services.
• Effective communication skills with cross‑functional teams and leadership.

Benefits

• A front row seat to life changing CGM technology.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or tuition reimbursement.
• An innovative organization committed to employees, customers, and communities.

Additional Information

• Travel required: 5-15%.
• Typically requires a Bachelor’s degree in a technical discipline with 5-8 years of experience, or a Master’s degree with 2-5 years, or a PhD with 0-2 years.
• This role is not a test role.
• The description is not exhaustive and duties may change.
• Equal Opportunity Employer.