Instrument Design QA Lead

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.