Geared toward candidates with regulated software verification experience and a background in building test automation frameworks, comfortable with ensuring clinical software compliance and working in a small, fast-moving team in Stockholm.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Neko Health via Ashby
MISSION
Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.
In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.
ABOUT THE ROLE
As a Senior System Verification Engineer, Software, you own and you are responsible for the system-level verification of our health software products. You define the test methods for system-level verification, develop the system tests those methods call for, and automate them, so software ships quickly and with high confidence in its safety, performance and compliance.
You'll join the Verification & Validation team, which supports Neko’s regulated product portfolio spanning SaMD and health software, and hardware medical devices (instruments). The team is small, growing and fast-moving, with real room to shape engineering quality, verification strategy, and how products are built as we scale.
WHAT YOU'LL DO
- 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 the test automation and infrastructure that make verification faster, more reliable and broader in coverage, integrated into the development and release pipelines.
- Turn software and system requirements into test methods and acceptance criteria, and work with software, data & AI and firmware engineers to make requirements clear, concrete and testable.
- Ensure that traceability matrices and V&V evidence are up to date so that every requirement is covered by verification throughout the product lifetime
- Automate the generation of audit-ready verification reports documenting results, defects and compliance status, and communicate findings to the teams that need them.
- Ensure verification activities comply applicable regulatory standards (IEC 62304, ISO 14971, IEC 82304-1, ISO 13485, EU MDR, FDA 21 CFR Part 820).
- Contribute to continuous improvements on how the team documents and reports verification, so practice is consistent across projects.
ABOUT YOU
Must-have:
- Verification of software in a regulated setting: 5+ years in system-level verification of SaMD or comparable regulated software products.
- Test automation you built yourself: frameworks, scripting and tooling for integration, regression and end-to-end testing, integrated into CI and release pipelines (Azure DevOps, GitLab CI, Jenkins or equivalent).
- Programming fluency to read and reason about the code you are verifying
- From requirements to test methods: turning software and system requirements into verification strategies and acceptance criteria and saying so when a requirement is not testable as written.
- Software lifecycle depth: IEC 62304 lifecycle processes (or comparable), software risk management under ISO 14971, and system integration testing across interconnected systems.
- Verification that stands up in an audit: traceability matrices, V&V plans and audit-ready reports, in clear and structured English.
- A degree in a relevant technical field: Software, Computer or Electrical Engineering, Physics or similar.
Nice to have:
- Hands-on verification of software products built on machine learning or algorithms
- Verifying software that spans cloud services and mobile apps end to end.
- Contributing to FDA submissions, EU MDR technical files or Notified Body audits.
- Experience using AI tools and agents in your own work
- Setting up reporting and dashboarding for continuous verification (results, coverage, traceability) inside build pipelines.
- Working alongside embedded verification on products where software runs on our own hardware.
WHY THIS ROLE MATTERS
Our software portfolio is growing faster than manual verification can scale, and it carries clinical decisions: what a member is told about a mole, a blood pressure reading or a heart signal. As a Senior System Verification Engineer, Software you build the verification that makes those answers trustworthy, and the automation that keeps it fast enough to ship frequently/regularly.
Source: Neko Health careers (Ashby)