Senior Quality Management R&D Engineer Software Development

Ambu A/S; Augsburg; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Ambu A/S seeks a Senior QM R&D Engineer – Software Development to ensure quality and regulatory compliance of software and AI-enabled medical devices across the product lifecycle. You will partner with software development teams and drive quality from concept through post-market activities.

Join a global, diverse team and influence quality processes, risk management, cybersecurity integration, and design controls for SaMD across sites including Augsburg, Germany.

Qualifications

• Experience in quality engineering within medical devices or regulated software.
• Hands-on software development projects in regulated environments.
• Knowledge of SaMD and AI-enabled medical software quality expectations.
• Familiarity with IEC 62304, ISO 14971 and EU AI Act implications.

Responsibilities

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

Skills

Quality Management

Software Development

Risk Management

Cybersecurity

AI in MedDev

Education

BSc or MSc in Software Engineering

Job description

Senior Quality Management R&D Engineer Software Development City: Augsburg Country/Region: Germany State: Business Area: Quality Assurance Department: Global Quality Management R&D Employment Type: Full-time Req ID: 10623

Senior Quality Management R&D Engineer

Software Development

Shape the Future of Medical Innovation

Are you passionate about quality and complianceinmedical device development?Do you have extensive experience in Quality Management across the product lifecycle— especially inSoftware 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 withAmbu.

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 Diversity

We 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 than42quality engineers based in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia, with this rolelocatedinAugsburg,Germany

Key responsibilities

As 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 theQuality Management partnerfor software development and AI-related R&D projects

• Driving and supportingrisk management activitiesfor software-based and software-enabled medical devices

• Ensuring compliance across thesoftware life cycle, including development, verification, validation, release, maintenance, and change control

• Supporting the integration ofcybersecurityinto product development and maintenance processes

• Providing quality oversight forAI-enabled medical device software, including lifecycle controls, documentation, traceability, and change management

• Supportingdesign control,life cycle management,design changes, andpost-market surveillanceactivities

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. Depending on your previous experience this role can also be a Senior position.Ideally,yourprofileincludes:

• ABSc or MScin Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering, or another relevant technical discipline

• Relevant experience inQuality Engineering / Quality Managementwithin themedical device,digital health,health software,or another highly regulated industry

• Hands-on experience working withsoftware development projectsin regulated environments

• Solid knowledge ofSoftware as a Medical Device (SaMD)and/or software embedded in medical devices

• Experience withAI-enabled productsor a strong understanding of quality and regulatory expectations for AI/ML-based medical software

• Strong understanding ofrisk management, including both safety risk and cybersecurity risk

• Experience working withglobal cross-functional teamsand translating quality requirements into business-relevant, actionable guidance

• In-depth knowledge of standards such asIEC 62304,ISO 14971,IEC 81001-5-1,ISO 13485,EU MDR,MDSAP,UK MD,QMSR

• Understanding oftheEU AI Actimplications 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

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.

About Ambu

Ambu has been bringing the 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.

For more information, please visit ambu.com or follow us on LinkedIn .