Software Design Quality Engineering Jobs (NOW HIRING)

*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 cloudbased, data platform, and AI/MLenabled systems.

• You will provide handson technical guidance to crossfunctional teams on IEC 62304, 21 CFR 820, and other applicable global regulations for softwareasaservice, data, and AIdriven 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 premarket 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 cloudhosted services, data pipelines, and AI/ML components to ensure regulatory compliance and product quality.

• You will support postmarket 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 cloudbased and AI/MLenabled 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 crossfunctional 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 cloudbased, data platform, API, and serviceoriented systems in a regulated environment.

• You have demonstrated handson knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485, and their application to softwareasaservice and datadriven 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 crossfunctional partners and can clearly present design assurance, risk, and compliance topics to technical teams and senior leadership.

What you'll get: (this section should not be modified)

• 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 degreein a technical discipline, and a minimumof 5-8 years related experience orMaster's degree and 2-5 yearsequivalent industry experience or a PhDand 0-2 years experience

Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option