Software Verification & Validation (V&V) Lead

About the Company

Nervio is a startup company developing groundbreaking AI-driven medical solutions in the field of Intra-operative Neurophysiology, supporting surgical teams during complex procedures.

Our solution combines advanced machine learning, clinical intelligence, and cutting-edge technologies to deliver real-time insights in the operating room.

Job Description

As a fast-growing medical technology startup, we 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.

Advantages

• Experience with Microsoft technologies (C#, WPF, SQL Server).

• Experience with Azure DevOps or similar ALM platforms (Boards, Test Plans, Pipelines).

• Experience working in a regulated software development environment, particularly Software as a Medical Device (SaMD) and FDA Design Controls.

• Familiarity with Quality Management Systems (QMS) and applicable medical device standards, including IEC 62304, ISO 14971, IEC 62366, and ISO 13485.