About the job
Mission
At Neko Health, our mission is to transform healthcare from a model focused on treating illnesses to one centered on prevention. We leverage cutting-edge, non-invasive technology and expert clinical knowledge to provide early, actionable health insights.
Founded in 2018 by Hjalmar Nilsonne and Daniel Ek, Neko Health is a pioneering Swedish healthcare technology firm. Our vision is to revolutionize the patient experience by prioritizing preventative health and early detection. We have innovated a medical scanning technology that allows for extensive and non-invasive health data collection, making it accessible and affordable for everyone. With over 500 dedicated employees, we proudly offer the Neko Body Scan experience at our locations in Stockholm, London, and Manchester.
About the Role
As a Senior Software Design Quality Assurance Engineer at Neko Health, you will play a crucial role in ensuring that our software medical device products comply with the highest regulatory and quality standards throughout their development lifecycle. You will implement design controls, manage risks, and execute verification and validation strategies for software and AI/ML-enabled medical devices. Your expertise will guarantee compliance with IEC 62304, IEC 82304, ISO 13485, EU MDR, and FDA regulations, primarily across cloud-based and SaaS platforms.
You will utilize your engineering mindset to enhance our quality assurance practices, incorporating AI-driven tools, automation, and DevOps methodologies to drive efficiency while adhering to stringent compliance standards. Your contributions will significantly impact our company's success by ensuring that our software systems are not only compliant but also optimized for performance, all while continuously innovating and developing our quality processes for SaMD and health software.

