Senior Software Design Assurance (Sr Software Design Quality) Engineer

DexCom • San Diego, CA

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About The Position

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.

Requirements

• Strong experience in software design assurance for cloud‑based, data platform, API, and service‑oriented systems in a regulated environment.
• 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.
• Proficiency includes applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification.
• 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.
• Skilled at reviewing and approving software design control deliverables to ensure traceability, risk control implementation, and regulatory compliance.
• Experience supporting software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components.
• Communicate effectively with cross‑functional partners and can clearly present design assurance, risk, and compliance topics to technical teams and senior leadership.
• 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 years equivalent industry experience or a PhD and 0-2 years experience.

Nice To Haves

• AI/ML experience or ASQ CSQE certification.

Responsibilities

• 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.
• 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.
• Lead the effective application, compliance, and continuous improvement of software development and validation practices for distributed systems, cloud services, and data platforms.
• 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.
• 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.
• 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.
• Support post‑market activities related to software anomalies, model behavior, data quality issues, risk assessments, and CAPA activities, as applicable.
• Author, review, and maintain technical documentation including Design History Files, SOPs, protocols, and reports for cloud‑based and AI/ML‑enabled systems.
• 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.
• Effectively communicate plans, progress, risks, and design assurance considerations to cross‑functional teams and senior leadership.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior