Neko Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Neko's vision is to shift healthcare from reactive treatment toward preventative health and early detection. This requires completely reimagining the patient's experience and incorporating the latest advances in sensors and AI. Neko Health has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is convenient and affordable for the public. The company is based in Stockholm, offering the Neko Body Scan experience at locations in Stockholm, London and Manchester, with over 500 employees.
About the Role
At Neko Health, we develop innovative medical technologies that enhance healthcare outcomes. As a Senior Software Design QA Engineer, you will ensure our software medical device products meet regulatory and quality standards throughout their development lifecycle. You will execute design controls, risk management, verification & validation, and design transfer activities for software and AI/ML-enabled medical devices, ensuring compliance with IEC 62304, IEC 82304, ISO 13485, EU MDR, and FDA regulations across cloud-based and SaaS platforms.
You'll bring an engineering mindset to quality assurance, leveraging AI-driven tools, automation, and DevOps practices to drive efficiency while maintaining rigorous compliance standards. Your work will directly contribute to the company's success by ensuring our software systems are not only compliant but also optimized for performance, while helping to shape our future by innovating and developing our quality processes for SaMD and health software.
Responsibilities
- Implement and maintain design control processes for software medical devices, ensuring compliance with IEC 62304, IEC 82304, ISO 13485, EU MDR, and FDA requirements.
- Lead risk management activities for software and AI/ML technologies in accordance with ISO 14971.
- Define and execute verification and validation strategies for software medical devices, including AI/ML validation and automated testing frameworks.
- Create and maintain audit-ready technical documentation including Software Design History Files (DHFs), risk files, and SOUP management.
- Plan, facilitate, and document design reviews ensuring designs meet safety, performance, usability, and cybersecurity requirements.
- Drive software design transfer activities, working with DevOps and Operations teams for smooth transition to production.
- Ensure DevOps-integrated quality gates and continuous compliance monitoring across CI/CD pipelines.
- Act as a subject matter expert for audits and inspections related to software design quality and cloud/ SaaS compliance.
- Develop scripts, automation, and AI-driven tools to streamline documentation, testing, and compliance workflows.
Requirements
- 5+ years of experience in Software Design Quality Engineering within the medical device industry.
- BSc or MSc in computer science, software engineering, biomedical engineering, or equivalent technical discipline.
- Strong knowledge of IEC 62304, IEC 82304, ISO 14971, ISO 13485, and EU MDR/FDA requirements for software medical devices.
- Hands-on experience with design controls, risk management, and verification & validation for software systems.
- Understanding of DevOps practices, CI/CD pipelines, and automated testing frameworks.
- Engineering mindset with experience in modern QA tooling, test automation, and AI-driven solutions.
- Proficient in scripting languages (Python, PowerShell) or eager to develop these skills.
- Strong communicator who thrives in cross-functional collaboration with software engineers and DevOps teams.
- Excellent written and verbal communication skills in English.
Nice to Have
- Experience from fast-scaling companies with frequent organizational change.
- Experience with Notified Body interactions and regulatory inspections for software medical devices.
- Knowledge of cloud platforms (AWS, Azure, GCP), containerization (Docker, Kubernetes), and infrastructure-as-code.
- Experience with AI/ML validation and verification methodologies for medical devices.
- Swedish language skills
Why Join Us?
At Neko Health, you'll work in an innovative and collaborative environment, shaping the future of AI/ML driven and cloud-native medical technologies while ensuring regulatory compliance and efficient design transfer. You'll leverage modern engineering practices, automation, and AI-driven tools to deliver quality excellence that drives business value.
If you're passionate about software design quality, risk management, compliance, and bringing an engineering mindset to QA through modern tooling and automation, we'd love to hear from you!
We offer a dynamic work environment with a high degree of autonomy that fosters growth and development. If you are passionate about building a better healthcare system for everyone and you thrive in a fast-paced environment, we would love to hear from you!
Please note: we perform background and reference checks as part of our interview process.
Show match analysis
