Senior Software Test Engineer
Core
Lead verification and validation efforts for cloud, mobile, and connected device platforms in a regulated medical device environment to ensure product quality and regulatory compliance.
Role type
Senior Software Test Engineer (V&V)
Builds
Cloud services, mobile applications, and connected devices for a health platform
Domain
Healthcare / Medical Devices / Regulated Software
Required skills
Software verification, Test automation, CI/CD pipelines, Risk management, Requirements traceability, Regulatory compliance (FDA/ISO/IEC), Defect triage, Design reviews, Test strategy, Mentorship
Preferred skills
Healthcare industry background, Automation-first mindset, Python/JavaScript/TypeScript, System integration testing, Cloud-native architectures, Microservices testing, CGM/biosensor data integration, AI/ML features
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 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; 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
