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Neko Health is a preventative healthcare company using proprietary technology and clinical care to deliver personalized health insights in a single non-invasive visit. The company takes full ownership of its systems—engineering, manufacturing, clinical operations, and quality management—treating all platforms and integrations as core to its mission.
As SW Tool Validation Lead, you will lead the software tool validation and computer system validation (CSV) function end-to-end: the systems, the assurance approach, and the team of CSV engineers delivering it. This is a hands-on leadership role combining strategic direction-setting with direct technical work.
Key Responsibilities:
- Act as process owner for software tool validation, setting assurance approach and standards
- Prioritize the tool estate by risk, allocating assurance effort based on patient safety, product quality, and data integrity impact
- Design and run assurance activities: map processes, identify risks and requirements, test systems, and form evidence-based approval views
- Maintain validated state as systems change, integrate, migrate, and retire—running validation as continuous activity
- Own assurance of AI-enabled tools where non-determinism, model updates, and opaque supplier behavior challenge conventional validation
- Own findings and issues across the estate: impact assessment, containment, 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
The role emphasizes pragmatic, risk-based validation aligned with GAMP 5 Second Edition and FDA Computer Software Assurance guidance. You will work in a fast-moving engineering environment, adapting assurance to continuous delivery rather than resisting it. The company has deliberately moved away from document-heavy validation toward a risk-based model where assurance effort follows patient safety impact.
Requirements:
- 10+ years in computer system validation, software tool validation, or software quality within medical device, pharmaceutical, or regulated industry
- BSc or MSc in Computer Science, Engineering, Information Systems, or equivalent technical discipline
- Deep, practical command of risk-based assurance: GAMP 5 (Second Edition), FDA Computer Software Assurance, ISO/TR 80002-2
- Genuinely technical: can get into systems, design and run meaningful tests, read configuration and integrations, form independent views
- Experience assuring AI/ML-enabled systems in regulated context with clear understanding of non-deterministic behavior implications
- Experience leading people or a function: line management or sustained technical leadership of validation team
- Track record of finding real problems in systems and closing them: fast triage, honest impact assessment, clear containment, sound judgment
- Working knowledge of EU MDR (2017/745), ISO 13485, FDA 21 CFR Part 820 and Part 11, EU GMP Annex 11
- Experience across both configured/SaaS platforms and internally developed software, including scripts, automation, integrations
- Comfortable in fast-moving engineering environments
- Excellent written and verbal communication skills in English
- Pragmatic mindset: understand risk-based business decisions, finite assurance capacity, and what gets validated deeply vs. lightly vs. deferred
Nice to Have:
- Hands-on experience with Azure DevOps as validation, traceability, and defect management platform
- Data integrity principles and practices (ALCOA+)
- Cloud-native and SaaS platforms in regulated context
- Notified Body or FDA inspection experience
- Swedish or German language skills
