---
title: 'Instrument Design QA Lead at Neko Health'
canonical: 'https://feeny.ai/job/instrument-design-qa-lead-neko-health-stockholm-nrajknx7ssxc'
type: 'job'
last_seen: '2026-11-08'
---

# Instrument Design QA Lead at Neko Health

- **Company:** [Neko Health](https://feeny.ai/companies/neko-health)
- **Location:** Stockholm, Sweden
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-04-02
- **Last confirmed live:** 2026-11-08
- **Apply:** https://jobs.ashbyhq.com/neko-health/7c6013a4-fb45-408f-9a86-80768239e4ee/application

> The Instrument Design QA Lead owns the quality and compliance of medical device hardware and firmware across a dedicated product family. This role involves leading risk management, design controls, and change management in accordance with ISO 13485, EU MDR, and FDA requirements, while serving as a subject matter exp...

## 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.

## Role Purpose

As the Instrument Design QA Lead, you will own the quality of Neko’s medical device hardware and firmware across a dedicated product family (Skin, Heart, Tissue): that what we build is safe, that it performs as intended, and that we can show it, from first design input through to design transfer. Regulatory compliance follows from getting that right; it is not the point of the job.

You hold authority to approve or reject quality deliverables and to enforce design control procedures. The engineering teams build and own their designs and their changes; your job is to make sure safety and quality are engineered in from the start rather than demonstrated after the fact, and to say so plainly when they are not. You will be part of a small, high-trust Quality team, working closely with hardware and firmware engineers, operations, and regulatory leads across an expanding product portfolio.

## What You’ll Do

- Quality assure design controls across the product lifecycle, reviewing and approving verification and validation plans and results, and keeping design inputs, outputs and traceability coherent across the family.
- Lead design reviews and risk management for your product family, owning the ISO 14971 lifecycle from hazard identification through residual risk evaluation and benefit-risk analysis, with a pragmatic and engineering-driven approach.
- Facilitate and quality assure change management, with the engineering teams driving their own design and medical device changes and you making sure each one is properly assessed, documented, reviewed and approved.
- Coordinate design transfer with Manufacturing QA and Production Engineering, moving designs into manufacturing with the evidence and controls in place.
- Quality assure the technical documentation and medical device file for your product family, keeping them complete, current and audit-ready under EU MDR and the FDA QMSR.
- Act as QA subject matter expert in internal and external audits, covering design quality, design controls and design transfer.
- Participate in post-market surveillance, identifying design-related issues and coordinating corrective and preventive actions.
- Lead continuous improvement, using modern QA tooling, AI-assisted documentation and automated testing to raise quality and development speed together.

## Who You Are

- 5+ years of experience in the medical device industry with a focus on hardware, firmware, or electrical equipment.
- BSc or MSc in engineering, biomedical engineering, systems engineering, physics, or equivalent technical discipline.
- Deep expertise in design controls and risk management, with hands-on experience of EU MDR (2017/745), ISO 13485, ISO 14971, and FDA 21 CFR Part 820 / Part 11.
- Strong working knowledge of IEC 60601-1, IEC 62471, IEC 62304, IEC 62366, and ISO 10993.
- Systems engineering mindset, able to connect and coherently address hardware, firmware, and systems integration across a product family.
- Self-leading and decision-capable; confident operating in a fast-paced, evolving environment with incomplete processes.
- Fluent English (written and verbal) with strong project management and cross-functional coordination skills.
- Genuine fluency with AI-driven workflows and modern digital tooling: eQMS, automation, and AI-assisted documentation are part of how you work, not add-ons.

## Nice to Have

- Experience with Notified Body interactions and regulatory submissions.
- Audit experience, internal and external.
- Knowledge of firmware development and embedded systems.
- Background in high-growth technology companies or startups.
- Active participation in medical device industry organisations or standards committees.
- Swedish language skills.

Why Join Us? You will own quality for a product family that goes into real clinics and produces real health data for real people. The team is small enough that your judgement carries, and close enough to engineering that you see the effect of it.

If you think quality is something you engineer in rather than inspect at the end, 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)

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