Senior Quality Management R&D Engineer Software Development

In this Senior QM R&D Engineer role, you ensure software and AI-enabled medical devices meet global quality and regulatory requirements throughout the full lifecycle. You partner with software development projects to drive quality excellence across development, release, maintenance, and post-market activities. You shape Ambu’s quality processes and support risk management, cybersecurity integration, and lifecycle controls for SaMD and embedded software. You join a diverse, international team to advance patient care through compliant, high-quality software solutions.

• employee benefits

• Act as the Quality Management partner for software development and AI-related R&D projects
• Drive and support risk management activities for software-based and software-enabled medical devices
• Ensure compliance across the software lifecycle including development, verification, validation, release, maintenance, and change control
• Support integration of cybersecurity into product development and maintenance processes
• Provide quality oversight for AI-enabled medical device software, including lifecycle controls, documentation, traceability, and change management
• Support design control, lifecycle management, design changes, and post-market surveillance activities

• Several years (5+) of experience in Quality Engineering / Quality Management within medical devices or regulated industries
• Hands-on experience with software development projects in regulated environments
• Solid knowledge of SaMD and/or software embedded in medical devices
• Experience with AI-enabled products or understanding of quality/regulatory expectations for AI/ML medical software
• Strong understanding of risk management, including safety and cybersecurity risk
• Experience with global cross-functional teams and translating quality requirements into actionable guidance
• In-depth knowledge of IEC 62304, ISO 14971, IEC 81001-5-1, ISO 13485, EU MDR, MDSAP, UK MD, QMSR
• Understanding of EU AI Act implications for high-risk AI in health/medtech

• Proactive mindset
• Strong cross-functional collaboration
• Ability to translate requirements into actionable guidance
• SaMD
• Software embedded in medical devices
• AI-enabled medical software