Senior Quality Management R&D Engineer Software Development

Ambu A/S; Augsburg; Vor Ort; EUR 65.000 - 80.000; Vollzeit

Benefits dieser Stelle

Opportunities for personal and professional development

Diverse international work environment

Wide range of employee benefits

Zusammenfassung

Ambu A/S in Augsburg is looking for a Senior Quality Management R&D Engineer to ensure compliance in software development for medical devices. You will play a crucial role in quality management throughout the product lifecycle.

The ideal candidate will have over 5 years of experience in Quality Engineering within regulated industries, a deep understanding of software lifecycle, and a proactive approach to risk management. Join us for a dynamic and innovative work environment.

Qualifikationen

• 5+ years of experience in Quality Engineering/Management in medical devices or regulated industries.
• Strong understanding of software lifecycle and compliance.
• Experience with AI and risk management.

Aufgaben

• Act as the Quality Management partner for software projects.
• Drive risk management activities for software devices.
• Ensure compliance across the software lifecycle.

Kenntnisse

Quality Management

Software Development

Risk Management

Collaboration

Regulatory Compliance

Ausbildung

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

Tools

IEC 62304

ISO 14971

AI-Enabled Products

Jobbeschreibung

Senior Quality Management R&D Engineer – Software Development

City: Augsburg; Country/Region: Germany; Employment Type: Full‑time; Req ID: 10293; Department: Global Quality Management R&D.

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.

Ifyou'reready 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 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.

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 the Quality Management partner for software development and AI‑related R&D projects
• Driving and supporting risk 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 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. 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
• Several years (5+) of experience in Quality Engineering / Quality Management within 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 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.

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.