Senior Software Test Engineer
Core
Lead verification and validation efforts for cloud, mobile, and connected device platforms in a regulated medical device environment.
Role type
Senior Software Test Engineer (Medical Device V&V)
Builds
Cloud services, mobile applications, and connected devices for consumer health platforms
Domain
Healthcare / Medical Devices / Cloud-Native Platforms
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
End-to-end software verification, FDA 21 CFR 820/ISO 13485/IEC 62304 compliance, test automation strategy, CI/CD pipeline integration, risk management, requirements traceability, defect triage, design review participation, manual and automated testing design, mentorship
Preferred skills
Healthcare industry background, automation-first mindset, scalable automation framework development, Python/JavaScript/TypeScript proficiency, HIPAA/GDPR understanding, system integration testing, cloud-native architecture knowledge
Technologies
GitHub Actions, Azure Pipelines, Harness, Pitesti, Playwright, Jest, REST Assured
Responsibilities
Own and execute end-to-end software verification for cloud services, mobile applications, and connected devices; Translate product and technical requirements into comprehensive verification strategies, test plans, and execution plans; Develop, maintain, and continuously improve verification plans, protocols, and reports in compliance with FDA 21 CFR, ISO 13485, and IEC 62304; Partner closely with product managers, architects, developers, and quality teams to ensure requirements are testable, traceable, and aligned with verification strategies; Support risk management activities, including risk analysis, defect triage, impact assessments, and root-cause investigations; Participate in design reviews and verify design inputs and outputs meet regulatory and quality expectations; Design and implement scalable manual and automated testing strategies spanning functional, integration, system, and regression testing; Contribute to and evolve test automation frameworks and CI/CD pipelines, embedding quality into continuous delivery workflows; Drive continuous improvement across verification processes, tools, metrics, and automation coverage; Mentor and guide junior test engineers, promoting strong engineering discipline, automation best practices, and regulatory excellence
Seniority
Senior, hands-on IC with mentorship responsibilities