About the job
Mission
Neko Health is dedicated to transforming healthcare by transitioning from reactive treatment to proactive prevention. Our innovative approach leverages cutting-edge, non-invasive technology along with clinical expertise to provide early and actionable health insights.
Founded in 2018 by Hjalmar Nilsonne and Daniel Ek, Neko Health envisions a future where healthcare is not just about responding to illness but about preventing it through early detection. By reimagining the patient experience and utilizing the latest advancements in sensors and AI, we aim to make health data collection straightforward, affordable, and accessible. Based in Stockholm, we proudly offer the Neko Body Scan experience in multiple cities including London and Manchester, employing a team of over 500 dedicated professionals.
About the Role
As a Senior Design Quality Assurance Engineer at Neko Health, you will play a pivotal role in ensuring that our medical devices (both hardware and firmware) meet stringent regulatory and quality benchmarks throughout their development journey. Reporting directly to the Instrument Design QA Manager, your responsibilities will encompass executing design controls, risk management, verification and validation, and design transfer activities while ensuring adherence to ISO 13485, IEC 60601-1, IEC 62471, EU MDR, and FDA regulations.
Your systems engineering mindset will be invaluable in quality assurance, as you bridge the gap between hardware, firmware, and systems integration. Utilizing our modern electronic Quality Management System (eQMS), you will enhance process efficiency through digital solutions, automation, and innovative methodologies. Your contributions will be essential in optimizing our medical devices for safety and performance, directly impacting the overall success of Neko Health. We are seeking a pragmatic, self-motivated individual who thrives in a collaborative environment where quality engineering and product development coexist harmoniously.
Responsibilities:
Lead risk management activities (ISO 14971) for medical devices, taking a pragmatic, engineering-driven approach to identify, evaluate, and control risks.
Implement design control processes throughout the product lifecycle, including verification and validation strategies, design reviews, and change assessments.

