Instrument Design QA Lead

Role Overview

• Own the quality and compliance of Neko's medical device hardware and firmware across a dedicated product family.
• 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.
• Lead risk management activities in accordance with ISO 14971 — identifying, evaluating, and controlling risks with a pragmatic, engineering-driven approach.
• 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.

Requirements

• 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.

Benefits

• Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.