SW Tool Validation Lead

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.

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.

• 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.

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

another regulated industry.

• 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.

• 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.

• 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.

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

integrations.

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.