Senior Software Design QA Engineer for Medical Devices

Senior Software Design QA Engineer

Location: Fully Remote (Europe)

Physical Office Hub: Stockholm

Employment Type: Full-time

We are seeking a Senior Software Design QA Engineer to ensure software medical device products meet regulatory and quality standards throughout their development lifecycle. This role is responsible for executing software design controls, risk management, verification and validation, and design transfer activities for cloud-based, SaaS, and AI/ML-enabled medical device software.

You will work closely with software engineering, DevOps, data, and product teams to ensure software development is compliant, efficient, and scalable. With foundational quality processes already in place, the focus of this role is on execution excellence, continuous improvement, and leveraging automation and modern tooling to support high-quality software delivery.

This is a hands-on, senior individual contributor role requiring strong regulatory knowledge, an engineering mindset, and the ability to balance quality rigor with development velocity in an agile, fast-moving environment.

What You’ll Do

• Implement and maintain software design control processes in compliance with IEC 62304, IEC 82304, ISO 13485, EU MDR, and FDA requirements
• Lead software risk management activities in accordance with ISO 14971, including risks related to cloud-based and AI/ML-enabled technologies
• Define and execute verification and validation strategies for software medical devices, including automated testing frameworks and AI/ML validation approaches
• Create, maintain, and review audit-ready technical documentation, including Software Design History Files (DHFs), risk management files, and SOUP documentation
• Plan, facilitate, and document software design reviews to ensure safety, performance, usability, and cybersecurity requirements are met
• Drive software design transfer activities, collaborating with DevOps and Operations teams to ensure smooth transition to production
• Implement and support DevOps-integrated quality gates and continuous compliance monitoring within CI/CD pipelines
• Act as a subject matter expert during audits and inspections related to software design quality and cloud/SaaS compliance
• Develop and use scripts, automation, and AI-driven tools to streamline documentation, testing, and compliance workflows
• Collaborate closely with cross-functional teams to embed quality and compliance into daily software development activities

Required Skills & Experience

• 5+ years of experience in Software Design Quality Engineering within the medical device or digital health industry
• BSc or MSc in Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline
• Strong hands-on experience with software design controls, risk management, and verification & validation
• Deep working knowledge of IEC 62304, IEC 82304, ISO 14971, ISO 13485, and EU MDR / FDA requirements
• Experience producing and maintaining audit-ready software documentation, including DHFs and SOUP management
• Solid understanding of Agile development environments, DevOps practices, CI/CD pipelines, and automated testing frameworks
• Engineering mindset with experience using modern QA tooling, automation, and AI-driven solutions
• Proficiency in scripting languages such as Python or PowerShell, or strong willingness to develop these skills
• Strong collaboration skills and ability to work effectively with software engineers, DevOps, and product teams
• Excellent written and verbal communication skills in English

Nice to Have

• Experience working in fast-scaling organizations with frequent organizational change
• Experience supporting audits and regulatory inspections with Notified Bodies or regulatory authorities
• 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

Apply

Ready to make your mark? Don’t hesitate to apply today as first round interviews will be arranged for the first week of February.

Apply directly through LinkedIn or send your CV to a.brenner@panda-int.com