Senior Quality Management R&D Engineer Software Development

Senior Quality Management R&D EngineerSoftware DevelopmentShape the Future of Medical InnovationAre you passionate about quality and compliance in medical device development? Do you have extensive experience in Quality Management across the product lifecycle— especially in Software Development? As Senior QM R&D Engineer – Software Development, you will play a key role in ensuring that software and AI-enabled medical device solutions are developed, maintained, and improved in compliance with global regulatory and quality requirements. You will act as the Quality partner for software development projects and help drive excellence across the full product life cycle - from concept and development to release, maintenance, and post-market activities. If you're ready to lead global R&D initiatives and drive continuous improvement, your next career move could be with Ambu. Why Join Ambu?

Ambu is a global leader in medical device innovation, dedicated to improving patient care. At Ambu, we are advancing our ambition to achieve global leadership in endoscopy. As part of our ZoomAhead strategy, EndoIntelligence is a central part as a unified platform that combines hardware, software, and AI to deliver integrated endoscopy solutions across the full procedure journey. Software is a core part, enabling intelligent, connected solutions that improve patient care and clinical outcomes. As a Senior QM R&D Engineer Software Development, you’ll be part of a collaborative, forward-thinking team that values integrity, innovation, and impact. Join a Team That Thrives on Collaboration and DiversityWe offer a collaborative and supportive team environment where mutual trust and collaboration are at the heart of everything we do.

Our team brings together talented professionals from across the globe, creating a truly international workplace that values different perspectives and fosters innovation. If you are looking for a role where teamwork, inclusivity, and shared success define the culture, this is the place for you. You’ll join a growing team of more than 42 quality engineers based in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia, with this rolelocated in Augsburg, Germany Key responsibilitiesAs a Senior QM R&D Engineer, you’ll play a pivotal role in shaping Ambu’s quality processes and driving excellence across global sites.

Your key responsibilities include: Acting as the Quality Management partner for software development and AI-related R&D projects Driving and supportingrisk management activities for software-based and software-enabled medical devices Ensuring compliance across the software life cycle, including development, verification, validation, release, maintenance, and change control Supporting the integration of cybersecurity into product development and maintenance processes Providing quality oversight for AI-enabled medical device software, including lifecycle controls, documentation, traceability, and change management Supporting design control, life cycle management, design changes, and post-market surveillance activitiesSuggested candidate profile Skills and experiences can be earned in many ways, and we understand that the best fit for the role cannot be prescribed on paper.

You are however likely to succeed in this position if you have a strong foundation in quality and a proactive mindset. Depending on your previous experience this role can also be a Senior position.

Ideally, your profile includes: A BSc or MSc in Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering, or another relevant technical discipline Relevant experience in Quality Engineering / Quality Management within the medical device, digital health, health software, or another highly regulated industry Hands-on experience working with software development projects in regulated environments Solid knowledge of Software as a Medical Device (SaMD) and/or software embedded in medical devices Experience with AI-enabled products or a strong understanding of quality and regulatory expectations for AI/ML-based medical software Strong understanding of risk management, including both safety risk and cybersecurity risk Experience working with global cross-functional teams and translating quality requirements into business-relevant, actionable guidance In-depth

knowledge of standards such as IEC 62304, ISO 14971, IEC 81001-5-1, ISO 13485, EU MDR, MDSAP, UK MD, QMSR Understanding of the EU AI Act implications for high-risk AI systems in health/medtech is a strong advantage. We offer:A great Team that thrives on collaboration and values different perspectives and fosters innovationOpportunities for personal and professional developmentA dynamic, diverse and international work environmentA wide range of employee benefits—professional, social, and financialReady to Apply?As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis.

Interviews are conducted on a rolling basis, so don’t wait—apply today and help us shape the future of patient care.