Senior SaMD System Verification Engineer

Neko Health; Stockholms kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Neko Health in Stockholm is seeking a Senior System Verification Engineer, Software, to own system-level verification of our SaMD and health software portfolio. You will define test methods, develop system tests, and automate them to ship safely and with confidence.

Join a fast-moving Verification & Validation team and help ensure regulatory compliance (IEC 62304, ISO 14971, ISO 13485, EU MDR, FDA 21 CFR Part 820) while improving traceability and audit-ready reports across projects.

Qualifications

• 5+ years in system-level verification of SaMD or comparable regulated software products.
• Experience building test automation integrated into CI/CD pipelines.
• Ability to read and reason about code under verification.
• Ability to turn requirements into verification strategies and acceptance criteria.
• Familiarity with IEC 62304 lifecycle processes and ISO 14971 risk management.
• Proven experience creating traceability matrices and audit-ready reports.
• Degree in Software, Computer, Electrical Engineering, Physics or similar.

Responsibilities

• Plan, execute and document system-level verification for SaMD and health software products, including complex interconnected systems.
• Design and implement test methods for regression and end-to-end system testing
• Build and improve test automation and infrastructure integrated into development and release pipelines
• Turn software and system requirements into test methods and acceptance criteria with engineers
• Ensure that traceability matrices and V&V evidence are up to date throughout product lifetime
• Automate the generation of audit-ready verification reports and communicate findings
• Ensure verification activities comply regulatory standards (IEC 62304, ISO 14971, IEC 82304-1, ISO 13485, EU MDR, FDA 21 CFR Part 820)
• Contribute to continuous improvements in documentation and reporting practices across projects

Skills

Regulated verification

Test automation

CI/CD tooling

Requirements-based testing

Traceability & V&V

Auditable reports

Programming fluency

IEC 62304 / ISO 14971

Education

Bachelor's or Master's in Software/Computer/Electrical Engineering, Physics or similar

Tools

Azure DevOps

GitLab CI

Jenkins

Test frameworks

Job description

Neko Health in Stockholm is seeking a Senior System Verification Engineer, Software, to own system-level verification of our SaMD and health software portfolio. You will define test methods, develop system tests, and automate them to ship safely and with confidence.

Join a fast-moving Verification & Validation team and help ensure regulatory compliance (IEC 62304, ISO 14971, ISO 13485, EU MDR, FDA 21 CFR Part 820) while improving traceability and audit-ready reports across projects.