Nervio
הנדסת חשמל ומחשבים, מתמטיקה
צפון
As a fast-growing medical technology startup, we, at Nervio, are seeking a Software Verification & Validation (V&V) Lead to establish and own the end-to-end V&V process for our AI-based Software as a Medical Device (SaMD) products.
You will lead the Software V&V function across the entire product development lifecycle, working closely with Product, R&D, Clinical, Data Science, Regulatory, and QA teams to ensure our products meet functional, quality, and regulatory requirements in accordance with applicable medical device standards.
This is a unique opportunity to shape Nervio's Software V&V practices, establish robust verification methodologies, and play a key role in delivering safe, reliable, and high-quality AI-based medical products.
Responsibilities:
- Lead the end-to-end Software V&V process throughout the product lifecycle
- Define and maintain the V&V strategy, test plans, quality gates, and release criteria
- Design, own, and execute system-level V&V activities
- Derive risk-based test cases and acceptance criteria while maintaining requirements traceability
- Lead defect management, including reporting, prioritization, root-cause analysis, corrective actions, and defect prevention
- Collaborate with cross-functional teams to support design reviews, risk management, product verification, validation, and successful product releases
Requirements:
- 3+ years of experience in Software V&V, Software QA, or System Testing, with responsibilities beyond test execution
- Proven experience defining and owning V&V scope, coverage, and acceptance criteria based on product risks and requirements, including requirements-based test design and end-to-end traceability
- Experience testing desktop applications, Web APIs, and data-layer services
- Experience working in Agile / Scrum development environments
- Strong analytical, troubleshooting, and root-cause analysis skills
- Strong ownership, technical leadership, and a hands-on approach
- Excellent communication and collaboration skills in multidisciplinary environments
- Experience with Microsoft technologies (C#, WPF, SQL Server) – an advantage
- Experience with Azure DevOps or similar ALM platforms (Boards, Test Plans, Pipelines – an advantage
- Experience working in a regulated software development environment, particularly Software as a Medical Device (SaMD) and FDA Design Controls – an advantage
- Familiarity with Quality Management Systems (QMS) and applicable medical device standards, including IEC 62304, ISO 14971, IEC 62366, and ISO 13485 – an advantage
Full-time position