Senior Software Design QA Engineer (AI)

TL;DR

Senior Software Design QA Engineer (AI): Ensuring software medical device products meet regulatory and quality standards throughout their development lifecycle with an accent on design controls, risk management, verification & validation for software and AI/ML-enabled medical devices. Focus on implementing design control processes, leading risk management activities, and defining and executing V&V strategies to ensure compliance and optimize performance.

Location: Hybrid (Stockholm / EU)

Company

hirify.global Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek, focused on shifting healthcare from reactive treatment toward preventative health and early detection through new medical scanning technology.

What you will do

• 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 according to 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, and ensure DevOps-integrated quality gates and continuous compliance monitoring.

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.
• 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.

Culture & Benefits

• Work in an innovative and collaborative environment, shaping the future of AI/ML driven and cloud-native medical technologies.
• Leverage modern engineering practices, automation, and AI-driven tools to deliver quality excellence that drives business value.
• Dynamic work environment with a high degree of autonomy that fosters growth and development.
• Opportunity to contribute to building a better healthcare system for everyone.