SW Tool Validation Lead

About the Role

At Neko Health, we develop innovative medical technologies that enhance healthcare outcomes. As SW Tool Validation Lead, you will lead our software tool validation and computer system validation (CSV) function end to end: the systems, the assurance approach behind them, and the team of CSV engineers who deliver it.

Neko takes full ownership of the systems it runs on. Engineering, manufacturing, clinical operations and the QMS are built on a mix of configured platforms, own-developed systems and the integrations we write between them, and we treat all of it as ours to understand, control and answer for. Your job is to make sure those systems are genuinely fit for their intended use, and that we can show it. We have deliberately moved away from uniformly document-heavy validation towards a risk-based model aligned with GAMP 5 Second Edition and the FDA’s Computer Software Assurance guidance, where assurance effort follows patient safety, product quality and data integrity impact. You will lead the next phase of that work.

This is a hands-on leadership role. You will set direction and coach a team, and you will also be in the systems yourself: testing them, breaking them, finding what is wrong before an auditor or a user does, and getting it fixed.

What You’ll Do

• Act as process owner for software tool validation, setting the assurance approach and the standards the function works to.

• Prioritise the tool estate by risk, allocating assurance effort according to patient safety, product quality and data integrity impact.

• Design and run assurance activities yourself: map the process, identify the risks and requirements, test the system, and form your own evidence-based view before you approve anything.

• Maintain the validated state of the estate as it changes, integrates, migrates and retires, running validation as a continuous activity rather than a periodic campaign.

• Own how we assure AI-enabled tools and systems, where non-determinism, model updates and opaque supplier behaviour break the assumptions conventional validation rests on.

• Own findings and issues across the estate, from honest impact assessment through containment to closure.

• Lead and develop the CSV team, with clear system ownership and engineers who make and defend their own risk calls.

• Represent the function in audits and Notified Body assessments, presenting and defending the assurance case for our systems.
  

Who You Are

• 10+ years in computer system validation, software tool validation or software quality within medical device, pharmaceutical or another regulated industry.

• BSc or MSc in Computer Science, Engineering, Information Systems or an equivalent technical discipline.

• Pragmatic to the core. You can take a risk-based business decision and own it: what gets validated deeply, what gets a light touch, what gets deferred with a control in place, and what we consciously accept. You understand that assurance capacity is finite and that spending it evenly is the same as spending it badly.

• Deep, practical command of risk-based assurance: GAMP 5 (Second Edition), FDA Computer Software Assurance, ISO/TR 80002-2.

• Genuinely technical. You can get into a system, design and run meaningful tests against it, read its configuration and integrations, and form your own view of whether it holds up.

• Experience assuring AI/ML-enabled systems in a regulated context, and a clear view of what changes when a system’s behaviour is not deterministic.

• Experience leading people or a function: line management, or sustained technical leadership of a validation team.

• A track record of finding real problems in systems and closing them: fast triage, honest impact assessment, clear containment, and the judgement to separate what actually matters from what merely looks non-conformant.

• Working knowledge of EU MDR (2017/745), ISO 13485, FDA 21 CFR Part 820 and Part 11, and EU GMP Annex 11.

• Experience across both configured/SaaS platforms and internally developed software, including scripts, automation and integrations.

• Comfortable in fast-moving engineering environments, adapting assurance to continuous delivery rather than fighting it.

• Excellent written and verbal communication skills in English.
  

Nice to Have

• Hands-on experience with Azure DevOps as a validation, traceability and defect management platform.

• Experience with data integrity principles and practices (ALCOA+).

• Experience with cloud-native and SaaS platforms in a regulated context.

• Notified Body or FDA inspection experience.

• Swedish or German language skills.
  

Why Join Us?

You will inherit a team that knows what it is doing. The interesting work ahead is scale: more systems, more integrations, more markets, while getting better at catching real problems early rather than describing them thoroughly afterwards.

If you think validation should make an organisation faster, safer and more confident rather than slower and more anxious, we would like to talk to you.