| Location | Stockholm, Sweden |
|---|---|
| Business Sector | Medical Device |
| Contact name | Aimee Brenner |
| Contact email | |
| Job ref | 26624 |
| Published | 3 days ago |
Senior Software Design QA Engineer
Stockholm, Sweden or Europe | Full-time Remote or Hybrid
Our client develops innovative medical technologies that enhance healthcare outcomes. As a Senior Software Design QA Engineer, you will ensure their software medical device products meet regulatory and quality standards throughout the development lifecycle. You will execute design controls, risk management, verification and 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 will 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 organization’s success by ensuring software systems are not only compliant but also optimized for performance, while helping shape the future by innovating and evolving quality processes for SaMD and health software.
• 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, collaborating with DevOps and Operations teams to ensure smooth transition to production.
• Ensure DevOps-integrated quality gates and continuous compliance monitoring across CI/CD pipelines.
• Act as a subject matter expert during 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.
• 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 an 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 and 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.
• Proficiency in scripting languages (Python, PowerShell) or a strong willingness 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.
• Experience working in fast-scaling organizations with frequent change.
• Experience supporting Notified Body interactions and regulatory inspections for software medical devices.
• Knowledge of cloud platforms (AWS, Azure, GCP), containerization (Docker, Kubernetes), and infrastructure-as-code practices.
• Experience with AI/ML validation and verification methodologies for medical devices.
• Swedish language skills.
At our client, the Senior Software Design QA Engineer will 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. They leverage modern engineering practices, automation, and AI-driven tools to deliver quality excellence that drives real business value.