Senior Software Design Assurance (Sr Software Design Quality) Engineer

DexCom; California (MO); On-site; USD 140,000 - 190,000; Full time

Job summary

Dexcom is seeking a Senior Software Design Assurance Engineer to support software design assurance across cloud-based and AI/ML-enabled systems. You will guide teams on IEC 62304, 21 CFR 820, and related regulations, ensuring traceability, validation, and compliance from discovery through post-market.

You will collaborate with Software, Regulatory, Marketing, and Project teams in a fast-paced environment and contribute to risk management and quality improvement initiatives.

Qualifications

• Bachelor’s degree in a technical discipline.
• 5–8 years of related experience in software quality or design assurance.
• Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485.
• Experience applying design assurance across SDLC for cloud/data/AI products.

Responsibilities

• Act as a core member of the R&D Quality Assurance Engineering team.
• Lead software design assurance activities for cloud-based and AI/ML-enabled systems.
• Provide guidance on requirements traceability, configuration management, and validation.
• Review and approve software design control deliverables for regulatory compliance.
• Support post-market activities related to anomalies, risk assessments, and CAPA.
• Communicate plans, risks, and compliance considerations to cross-functional teams.

Skills

Software design assurance

Regulated software development

AI/ML experience

Education

Bachelor’s degree in a technical discipline

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

Job description

Headquarters: San Diego URL: http://dexcom.com 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. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

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 Where you come in: 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.

What makes you successful:

• 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 design control deliverables to ensure traceability, risk control implementation, and regulatory compliance. You have experience supporting software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components. You communicate effectively with cross‑functional partners and can clearly present design assurance, risk, and compliance topics to technical teams and senior leadership.

What you’ll get:

A front row seat to life changing CGM technology.

Learn about our brave #dexcomwarriors community .

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.

An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required: 5-15%

Experience and Education Requirements: Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degr