Senior System Verification Engineer

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

• Partner with design engineers to ensure medical device systems are compliant with standards like IEC 60601 and regulatory requirements like FDA and MDR
• Translate regulatory requirements into actionable guidance for design decisions
• Influence product requirements to ensure they are testable, traceable, and specify compliance needs
• Develop efficient verification methodologies, tools, and workflows for end-to-end, integration, and regression testing
• Coordinate with external test houses for specialized testing including EMC, electrical safety, and environmental tests
• Ensure continuity of test requirements through design transfer to manufacturing
• Create comprehensive test reports documenting results, defects, and compliance status
• Maintain traceability matrices to ensure all system requirements are covered by verification activities

Requirements

• Bachelor’s or Master’s degree in Engineering or a related technical field
• 5+ years of experience in system verification and validation within a regulated industry, ideally medical devices
• Experience with complex embedded systems (hardware, firmware, software) and system-level testing
• Strong familiarity with IEC 60601 series standards
• Familiarity with regulatory frameworks such as FDA, MDR, and ISO 14971
• Hands-on experience developing and executing manual and automated test methods
• Excellent collaboration and communication skills
• Proficiency in English