Sr SW Design Quality Engineer

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). Travel required: 5-15%. Remote workplace: home office; not required to live within commuting distance of an assigned Dexcom site.

Responsibilities

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; Support post-market activities related to software anomalies, model behavior, data quality issues, risk assessments, and CAPA activities; 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; 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; 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 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; Ability to communicate effectively with cross-functional partners and 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 a Master's degree and 2-5 years equivalent industry experience, or a PhD and 0-2 years experience

Nice to have

AI/ML experience; ASQ CSQE certification

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 qualified tuition reimbursement; An exciting and innovative, industry-leading organization committed to employees, customers, and the communities it serves