# Instrument Design QA Lead - Company: [Neko Health]() - Location: Stockholm - Remote: Yes - Team: Engineering - Employment type: Full Time - Posted: April 2, 2026 ## 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 and compliance of Neko's medical device hardware and firmware across a dedicated product family — ensuring that everything we build meets applicable regulatory standards from first design input to final design transfer. This is not a support function. You hold authority to approve or reject quality deliverables, enforce design control procedures, and ensure that compliance is engineered in from the start — not layered on at the end. Your work directly enables Neko's mission: every device that reaches a member is safe, effective, and built to the highest standard. You will be part of a small, high-trust Quality & Regulatory team working closely with hardware and firmware engineers, operations, and regulatory leads across an expanding product portfolio. **What You'll Deliver in the First 6–12 Months** * Take full QA ownership of one product family (Skin, Heart, Tissue) — running design controls, risk management, and change management in compliance with ISO 13485, EU MDR, and FDA requirements. * Clear the backlog of open Medical Device Changes and establish a functioning change control cadence that keeps pace with the engineering team. * Embed QA into all relevant Engineering Epics — no product development running without active QA coverage. * Deliver an audit-ready design history file and technical documentation for your assigned product family. **What You'll Do** **Lead risk management activities in accordance with ISO 14971 — identifying, evaluating, and controlling risks with a pragmatic, engineering-driven approach.** Own the full risk management lifecycle for your product family, from hazard identification through residual risk evaluation and benefit-risk analysis. **Drive design controls across the product lifecycle.** Including verification and validation strategy, design reviews, design inputs and outputs, and traceability throughout. **Own change management.** Ensure design changes are properly assessed, documented, reviewed, and approved in compliance with applicable regulations and internal procedures. **Coordinate design transfer.** Work closely with manufacturing QA Lead and Production **Support technical documentation for regulatory submissions.** Including Design History Files and Technical Documentation under EU MDR. **Lead continuous improvement initiatives.** Leveraging modern QA tooling, AI-assisted documentation, and automated testing frameworks to improve quality, compliance, and development speed. **Act as QA subject matter expert for internal and external audits.** Covering medical device design quality, design controls, and design transfer. **Participate in post-market surveillance.** Identify design-related issues and coordinate corrective and preventive actions. **Minimum Qualifications** * BSc or MSc in engineering, biomedical engineering, systems engineering, physics, or equivalent technical discipline. * 5+ years of experience in the medical device industry with a focus on hardware, firmware, or electrical equipment. * Deep expertise in design controls and risk management — hands-on experience with 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. **Preferred** * Swedish language skills. * Experience with Notified Body interactions and regulatory submissions. * Audit experience, internal and external. * Background in high-growth technology companies or startups. * Knowledge of firmware development and embedded systems. * Active participation in medical device industry organisations or standards committees. ## Apply [Apply on Neko Health]() Canonical job page: