Senior Software Design Assurance (Sr Software Design Quality) Engineer

Role Overview

Senior Software Design Assurance (Sr Software Design Quality) Engineer in DexCom’s R&D Quality Assurance Engineering team. You will provide technical guidance and hands-on support to software teams to ensure software design conformance to established development processes and applicable safety and quality regulations.

Responsibilities

• Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems
• Provide hands-on technical guidance on relevant regulations and standards, including:
  • IEC 62304
  • 21 CFR 820
  • ISO 13485 and ISO 14971 (as applicable)
• Lead 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 such as:
  • Software Hazard Analysis (SHA)
  • Design FMEA
  • Risk controls covering cloud infrastructure, data processing, and AI/ML functionality
• Guide software design and test teams on software design assurance activities including:
  • Requirements traceability
  • Software configuration management
  • Tool validation
  • Integration assurance for cloud and data services
• Review and approve software design control deliverables for cloud-hosted services, data pipelines, and AI/ML components to ensure regulatory compliance and product quality
• Support post-market activities for software anomalies, model behavior, data quality issues, risk assessments, and CAPA as applicable
• Author/review/maintain technical documentation such as Design History Files, SOPs, protocols, and reports
• Assess change control activities for infrastructure, data, and model changes to ensure no adverse product impact and continued compliance
• Communicate plans, progress, risks, and design assurance considerations to cross-functional partners