---
title: 'SW Tool Validation Lead at Neko Health'
canonical: 'https://feeny.ai/job/sw-tool-validation-lead-neko-health-stockholm-k6px967wk3ax'
type: 'job'
last_seen: '2026-11-08'
---

# SW Tool Validation Lead at Neko Health

- **Company:** [Neko Health](https://feeny.ai/companies/neko-health)
- **Location:** Stockholm, Sweden
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-09-24
- **Last confirmed live:** 2026-11-08
- **Apply:** https://jobs.ashbyhq.com/neko-health/3532b6ba-c3d0-46c6-9f30-280a47a5f20d

## Job description

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

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.

## About Neko Health

## Company Overview
- **One-liner**: Neko Health is a healthcare technology company that has engineered a proprietary, data-driven preventive health scan to detect early signs of disease in otherwise healthy individuals.
- **Entity Type**: Private (Funding Stage: Series A)
- **Headquarters**: Stockholm, Sweden
- **Founded**: 2018
- **Founders**: Daniel Ek (Co-founder, also founder/CEO of Spotify) and Hjalmar Nilsonne (Co-founder)

## Core Business
- Primary industry/industries: Healthcare Technology, Preventive Medicine, Clinical Diagnostics
- Target customers: B2C – Health-conscious individuals; B2B Potential – Self-insured employers
- Mission or purpose statement: “To provide healthcare that’s proactive instead of reactive – so that people can live longer, healthier lives.”

## Products & Services
- **[The Neko Health Scan]**: A 60-minute, full-body health check that captures millions of data points across the skin, heart, blood, and circulation using four proprietary devices (Derma, Spectrum, Echo, and Neko Lens). Includes an unrushed consultation with a doctor where results are discussed immediately. The scan is priced at approximately 2750kr (~$260) in Sweden and is designed for asymptomatic, healthy individuals looking for prevention.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (as of mid-2026).
- **Key Metric**: Total Funding – **$325.1M** (one prior funding round).
- **Notable Investors/Partners**: Backed by “investors who have built and scaled some of the most ambitious technology companies of the last two decades” (individual names not publicly listed on career page). The company has strong ties to the tech and startup ecosystem.
- **Growth Signals**: Over 1,000 employees (more than half in clinical roles). Aggressive expansion with active clinic locations in London, Manchester, Birmingham, Stockholm, and plans for more. Job postings have increased +344.4% year-over-year (as of mid-2026), indicating rapid scaling.

## Competitive Advantages
- **Proprietary Hardware**: All four scanning devices are designed, engineered, and assembled in-house in Stockholm, creating a hard-to-replicate technological moat.
- **Integrated Clinical Model**: Unlike traditional clinics or digital health apps, Neko combines its proprietary hardware with on-site doctors, clinical researchers, and data science under one roof with a low patient volume per doctor ( ~9 members/day vs. 30+ in standard care). This enables a focus on prevention, not just treatment.
- **Data Moat**: The system captures millions of structured data points per scan, allowing for peer benchmarking and longitudinal tracking over years, creating a powerful, network-effect dataset for preventive health insights.
- **Leadership**: Co-founded by Daniel Ek (Spotify) and Hjalmar Nilsonne.

## Strategic Focus
- **Scaling the Scan Room**: Neko is actively testing a second-generation modular scan room platform designed to capture more signals and scale to new locations.
- **Global Expansion**: Opening new clinics across the UK and Europe, with a clear intent to make the service more accessible.
- **Clinical Research & Governance**: Continued focus on validating their devices with clinical studies and building a clinical leadership team (including ex-NHS and Amazon Health executives) to establish preventive care as a formal clinical discipline.

## Why Work Here
- **Mission-Driven**: The company was founded to solve the fundamental problem of late-stage diagnosis by focusing on prevention. The work is presented as having a direct, positive impact on human longevity.
- **Culture & Engineering**: The company actively showcases a deep engineering culture where “clinical insight can become a hardware iteration overnight.” Clinicians and engineers share the same floor, fostering rapid iteration and innovation.
- **Compensation & Benefits**: Salaries are benchmarked via market research. Benefits include comprehensive Medical, Dental, and Vision Insurance, 401K, Paid Time Off, Life Insurance, Disability Insurance, CME Days, and Commuter Benefits.
- **Work Model**: Roles are **on-site** at specific clinic locations. Training for medical roles is fully paid. The interview process is designed to give candidates a feel for the culture and mission.
- **Growth Trajectory**: With 80+ active job postings and triple-digit growth in hiring, the company is in a high-growth phase, offering significant career development opportunities.

## Sources
1. [nekohealth.com](https://www.nekohealth.com/en)
2. [nekohealth.com](https://www.nekohealth.com/us/en/about)
3. [linkedin.com](https://www.linkedin.com/company/nekohealth)
4. [nekohealthcareers.com](https://www.nekohealthcareers.com/)
5. [jobs.ashbyhq.com](https://jobs.ashbyhq.com/neko-health)

## Other roles at Neko Health

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- [Family Medicine Physician](https://feeny.ai/job/family-medicine-physician-neko-health-miami-7xghg55er0y7) — Miami, FL
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- [Nurse Practitioner](https://feeny.ai/job/nurse-practitioner-neko-health-washington-2dfedzz2enhm) — Washington, DC
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