V&V Engineer

Health checks are delivered as software through our iOS and Android apps and an Azure-hosted platform with managed ML endpoints. You will be co-responsible for the safety and effectiveness of our medical devices through comprehensive Verification and Validation (V& V) processes. You will work throughout the entire Software Development Life Cycle (SDLC), focusing on software and integration testing for both products and internal tools. You will engage engineering, clinical, and quality teams so that what we build and what we submit stay in step. It is an AI agent-first organization, and you will be expected to use AI tools proactively in your daily work.

Responsibilities:

• Compliance-as-Code: Build workflows that map verification evidence to regulatory standards and generate that evidence automatically.
• Testing Strategy: Own comprehensive test plans, protocols, and execution reports for medical device software.
• V& V Leadership: Drive formal software verification and validation, ensuring adherence to IEC 62304 (Class C) and ISO 14971.
• Process Automation: Push test automation, CI/CD pipelines, and new testing techniques forward, including LLM-assisted quality gates.
• Hardware Integration: Work with systems engineers to test multi-tasking systems and signal-processing applications on real hardware.
• Technical File Artefact Ownership: Establish and maintain the software-level records of the technical file as living, reconciled artifacts.

Requirements:

• 8+ years in software testing, particularly for complex or safety-critical systems.
• Proficiency in at least one programming language (preferably Rust, Swift/Kotlin, Python, or TypeScript).
• Experience in highly regulated industries, preferably medical device development.
• Strong hands-on background in CI/CD, test automation, and build systems.
• Working knowledge of security risk management for software (threat modeling, vulnerability/CVE assessment, software supply chain, and provenance risk), e. g., IEC 81001-5-1 or equivalent exposure.
• Fluency with AI tools such as LLMs and AI-assisted workflows.

Skills

Medical Devices, validation, verification, CI/CD, IEC 62304, ISO 14971, QA, testing, V&V