Senior Software Design Assurance (Sr Software Design Quality) Engineer

Headquarters:
San Diego
URL:

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream:
To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started:
Improving human health.

* This is NOT a test role*

The Senior Software Design Assurance (Sr Software Design Quality) Engineer provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971).

This role will be responsible for various aspects of Software Design Assurance with a focus on product improvement, new product development, and defect prevention.

This position will interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering, Cybersecurity, and others).

A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

* This is NOT a test role*

• You will actively participate as a core member of the R&D Quality Assurance Engineering team, supporting software design assurance for cloud‑based, data platform, and AI/ML‑enabled systems.

• You will provide hands‑on technical guidance to cross‑functional teams on IEC 62304, 21 CFR 820, and other applicable global regulations for software‑as‑a‑service, data, and AI‑driven products.

• You will lead the effective application, compliance, and continuous improvement of software development and validation practices for distributed systems, cloud services, and data platforms.

• You will drive pre‑market risk management deliverables, including Software Hazard Analysis (SHA), design FMEA, and risk controls related to cloud infrastructure, data processing, and AI/ML functionality.

• You will guide Software Design and Test teams on software design assurance activities such as requirements traceability, software configuration management, tool validation, and integration of cloud and data services.

• You will review and approve software design control deliverables associated with cloud‑hosted services, data pipelines, and AI/ML components to ensure regulatory compliance and product quality.

• You will support post‑market activities related to software anomalies, model behavior, data quality issues, risk assessments, and CAPA activities, as applicable.

• You will author, review, and maintain technical documentation including Design History Files, SOPs, protocols, and reports for cloud‑based and AI/ML‑enabled systems.

• You will assess change control activities related to infrastructure, data, or model changes to ensure no adverse impact to product performance and to maintain a compliant state.

• You will effectively communicate plans, progress, risks, and design assurance considerations to cross‑functional teams and senior leadership.

Nice to have: AI/ML experience or ASQ CSQE certification.

• You bring strong experience in software design assurance for cloud‑based, data platform, API, and service‑oriented systems in a regulated environment.

• You have demonstrated 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.

• Your proficiency includes applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification.

• You have 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.

• You are skilled at reviewing and approving software…