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Neko Health is redefining preventative care through data-driven health insights delivered in a single, non-invasive visit. As Senior System Verification Engineer, Software, you will own system-level verification of Neko's regulated health software products and SaMD (Software as a Medical Device) portfolio.
You will define test methods for system-level verification, develop and automate system tests, and ensure software ships with high confidence in safety, performance, and regulatory compliance. Working within the Verification & Validation team, you'll have significant influence over engineering quality and verification strategy as the team scales.
Key responsibilities include:
- Planning, executing, and documenting system-level verification for SaMD and health software products, including complex interconnected systems
- Designing and implementing test methods for regression and end-to-end system testing
- Building and improving test automation infrastructure integrated into development and release pipelines
- Converting software and system requirements into testable acceptance criteria, collaborating with software, data & AI, and firmware engineers
- Maintaining traceability matrices and V&V evidence to ensure complete requirement coverage throughout product lifetime
- Automating generation of audit-ready verification reports documenting results, defects, and compliance status
- Ensuring verification activities comply with applicable regulatory standards (IEC 62304, ISO 14971, IEC 82304-1, ISO 13485, EU MDR, FDA 21 CFR Part 820)
- Contributing to continuous improvements in documentation and reporting practices across projects
Required qualifications: 5+ years in system-level verification of SaMD or comparable regulated software; hands-on test automation experience with frameworks and CI/CD integration (Azure DevOps, GitLab CI, Jenkins); programming fluency; ability to translate requirements into verification strategies; deep knowledge of IEC 62304 lifecycle processes and ISO 14971 risk management; ability to produce audit-ready traceability matrices and V&V documentation; degree in Software, Computer, or Electrical Engineering, Physics, or similar field.
Nice-to-have skills include verification of ML-based software products, cloud/mobile end-to-end verification, FDA/EU MDR submission experience, AI tool proficiency, and continuous verification reporting/dashboarding.
