Senior Software Design Assurance Engineer - Cloud & AI/ML

Regulatory Jobs; United States; Presencial; USD 96.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits package

Career development

Global growth

Tuition reimbursement

Company culture

Descripción de la vacante

Dexcom is seeking a Senior Software Design Assurance Engineer to join its R&D Quality Assurance team, focusing on cloud‑based data platforms and AI/ML‑enabled systems. You will ensure conformance to IEC 62304, FDA 21 CFR 820, and ISO 13485 within a regulated environment.

You will guide cross‑functional teams, drive risk management, and maintain Design History Files, SOPs, and reports for cloud and AI/ML components while collaborating with leadership.

Formación

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 year equivalent industry experience or a PhD and 0-2 years experience.
• Nice to have: AI/ML experience or ASQ CSQE certification.

Responsabilidades

• 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.

Conocimientos

Software QA

Cloud-based

Data platforms

AI/ML experience

IEC 62304

FDA 21 CFR 820

ISO 13485

Regulatory compliance

Educación

Bachelor’s degree in a technical discipline

Master’s degree in a technical discipline

PhD in a technical discipline

Descripción del empleo

Dexcom is seeking a Senior Software Design Assurance Engineer to join its R&D Quality Assurance team, focusing on cloud‑based data platforms and AI/ML‑enabled systems. You will ensure conformance to IEC 62304, FDA 21 CFR 820, and ISO 13485 within a regulated environment.

You will guide cross‑functional teams, drive risk management, and maintain Design History Files, SOPs, and reports for cloud and AI/ML components while collaborating with leadership.