Senior Software Test Engineer

The Senior Software Test Engineer - Medical Device Cloud & Mobile leads verification and validation of cloud services, mobile apps, and connected health devices in a regulated environment. The role designs and executes test strategies, plans, and cases, builds and improves automation and CI/CD integration, ensures traceability and regulatory-compliant documentation, supports risk analysis and defect triage, and mentors junior test engineers to help deliver safe, reliable digital health products.

Responsibilities

• Lead end-to-end verification and validation for cloud, mobile, and connected device software in a regulated environment.
• Develop and maintain verification strategies, detailed test plans, cases, and execution schedules from requirements.
• Ensure test documentation, traceability, and reports comply with FDA 21 CFR 820, ISO 13485, and IEC 62304.
• Design and enhance manual and automated test suites across functional, integration, system, and regression levels.
• Contribute to and improve test automation frameworks and CI/CD pipelines to embed quality into delivery workflows.
• Collaborate with product, architecture, development, and quality teams to ensure clear, testable, traceable requirements.
• Support risk management through defect triage, impact analysis, and root cause investigation for software issues.
• Mentor junior test engineers in testing best practices, automation techniques, and regulatory expectations.

Required Skills

• Medical device software verification & validation
• Test automation (mobile, web, API)
• CI/CD pipelines (e.g., Git
• Hub Actions, Azure Pipelines)
• Regulated software documentation & traceability
• Risk management & defect triage
• Cloud-native and microservices testing
• System integration and end-to-end testing
• Programming (Python, JavaScript, Type
• Script)
• Regulatory standards (FDA 21 CFR 820, ISO 13485, IEC 62304)
• Data privacy compliance (HIPAA, GDPR)