QM R&D Engineer - Software Development

Ambu A/S; Augsburg; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Opportunities for personal and professional development

Dynamic work environment

Wide range of employee benefits

Zusammenfassung

Ambu A/S is looking for a Quality Management R&D Engineer to join their team in Augsburg. You will lead quality processes and ensure compliance across global software development projects.

This role requires a strong foundation in quality and familiarity with standards for medical devices, especially those incorporating AI. Join a diverse team dedicated to improving patient care through innovative solutions.

The position offers opportunities for professional development and a collaborative work environment.

Qualifikationen

• Experience in Quality Engineering within the medical device industry.
• Hands-on experience with software development projects in regulated environments.
• Understanding of standards and regulations for AI/ML-based medical software.

Aufgaben

• Support quality management for software development projects.
• Drive risk management activities for medical devices.
• Provide oversight for documentation and traceability.

Kenntnisse

Quality Engineering

Software Development

AI-related product knowledge

Risk Management

Ausbildung

BSc or MSc in Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering

Tools

IEC 62304

ISO 14971

ISO 13485

Jobbeschreibung

Department: Global Quality Management R&D

Employment Type: Full-time

Quality Management R&D Engineer

Software Development

Shape the Future of Medical Innovation

Are you passionate about quality and compliance in medical device development? Do you have experience in Quality Management across the product lifecycle— especially in Software Development?

As 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 support 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 Zoom‑Ahead strategy, EndoIntelligence is a central part of 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 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 Diversity

We offer a dynamic 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 role located in Augsburg, Germany.

Key responsibilities

As a 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:

• Quality Management support for software development and AI‑related R&D projects.
• Driving and supporting risk management activities for software‑based and software‑enabled medical devices.
• 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 activities.

Suggested 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. Ideally, your profile includes:

• A BSc or MSc in Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering, or another relevant technical discipline.
• Work 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.
• Understanding of risk management, including both safety risk and cybersecurity risk.
• 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 innovation.
• Opportunities for personal and professional development.
• A dynamic, diverse and international work environment.
• A wide range of employee benefits—professional, social, and financial.

Ready 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.

About Ambu

Ambu has been bringing their solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single‑use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.