Validation & Verification Lead

About the Company

Neko Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Neko's vision is to shift healthcare from reactive treatment toward preventative health and early detection by incorporating the latest advances in sensors and AI.

Responsibilities

• Lead Verification & Validation activities for SaMD and complex interconnected systems across product development projects
• Define and drive the V&V strategy, including traceability, test methodology, and generation of audit-ready documentation
• Ensure V&V processes are properly implemented in accordance with SOPs and contribute to improving infrastructure
• Collaborate with cross-functional teams to ensure requirements are clear, testable, and traceable
• Represent V&V in product changes and regulatory submissions, including interactions with authorities such as the FDA

Requirements

• Bachelor’s or Master’s degree in Engineering or a related technical field
• Proven experience leading Verification & Validation in regulated environments, ideally medical devices or SaMD
• Strong understanding of software lifecycle processes, system integration, and system-level verification
• Experience supporting regulatory submissions and producing audit-ready documentation
• Familiarity with regulatory frameworks such as FDA, MDR, and ISO 14971
• Strong collaboration and communication skills