Instrument Design QA Lead

About the Company

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission is to make data-driven, preventative care accessible to more people through proprietary technology and direct clinical care.

Responsibilities

• Lead risk management activities in accordance with ISO 14971
• Own the full risk management lifecycle for assigned product families
• Drive design controls including verification, validation, and traceability
• Manage design changes and ensure compliance with internal procedures
• Coordinate design transfer with manufacturing and production teams
• Support technical documentation for regulatory submissions (DHF, EU MDR)
• Lead continuous improvement using modern QA tooling and AI-assisted documentation
• Act as QA subject matter expert for internal and external audits
• Participate in post-market surveillance and CAPA coordination

Requirements

• BSc or MSc in engineering, biomedical engineering, systems engineering, or physics
• 5+ years of medical device industry experience (hardware, firmware, or electrical)
• Deep expertise in EU MDR, ISO 13485, ISO 14971, and FDA 21 CFR Part 820/11
• Working knowledge of IEC 60601-1, IEC 62471, IEC 62304, IEC 62366, and ISO 10993
• Systems engineering mindset covering hardware and firmware integration
• Fluent English (written and verbal)
• Proficiency with AI-driven workflows and modern digital tooling

Preferred Qualifications

• Swedish language skills
• Experience with Notified Body interactions and regulatory submissions
• Internal and external audit experience
• Background in high-growth technology companies or startups
• Knowledge of firmware development and embedded systems