Sr SW Design Quality Assurance Engineer
About The Position
The Senior Software Design Assurance Engineer provides technical support and guidance to software teams to ensure conformance with software development processes and applicable safety, quality-system regulations, and standards, including IEC 62304, ISO 13485, and ISO 14971. The role focuses on product improvement, new product development, and defect prevention, supporting cloud-based, data-platform, and AI/ML-enabled systems in a fast-paced environment with shifting priorities. As a core member of the R&D Quality Assurance Engineering team, the engineer works with Software Engineering, Software Test, Regulatory Affairs, Marketing, Project Managers, Systems Engineering, Cybersecurity, and other groups. The role guides teams on applicable regulations and software design assurance practices; leads compliance and continuous improvement across software development and validation; supports risk management, design controls, change control, and post-market activities; and communicates plans, progress, risks, and assurance considerations to cross-functional teams and senior leadership. The position is remote, with a home office and no requirement to live within commuting distance of a Dexcom site. A hybrid environment may be available to employees who live within commuting distance of a site. Travel required is 5–15%.
Requirements
- Typically, a bachelor’s degree in a technical discipline and 5–8 years of related experience; or a master’s degree and 2–5 years of equivalent industry experience; or a PhD and 0–2 years of experience.
- 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, and 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.
- Skill reviewing and approving software design control deliverables for traceability, risk-control implementation, and regulatory compliance.
- Experience supporting software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components.
- Effective communication skills, including presenting design assurance, risk, and compliance topics to technical teams and senior leadership.
Nice To Haves
- AI/ML experience.
- ASQ CSQE certification.
Responsibilities
- Provide 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 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 for cloud infrastructure, data processing, and AI/ML functionality.
- Guide Software Design and Test teams on requirements traceability, software configuration management, tool validation, and integration of cloud and data services.
- Review and approve software design control deliverables for 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, as applicable.
- Author, review, and maintain technical documentation, including Design History Files, SOPs, protocols, and reports.
- Assess change control activities involving infrastructure, data, or model changes to ensure product performance is not adversely affected and the compliant state is maintained.
- Communicate plans, progress, risks, and design assurance considerations to cross-functional teams and senior leadership.
Benefits
- Full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Career development through in-house learning programs and/or qualified tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
