QM R&D Engineer - Software Development

Ambu; Augsburg; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Opportunities for personal and professional development

Dynamic and international work environment

Wide range of employee benefits

Zusammenfassung

Ambu in Augsburg is seeking a Quality Management R&D Engineer – Software Development to ensure compliance with global standards for software and AI-enabled medical devices. The role involves supporting software projects and driving quality oversight throughout the product lifecycle.

The ideal candidate holds an ABSc or MSc in a relevant field, and has experience in Quality Engineering within regulated industries. Ambu offers a collaborative and innovative work environment with opportunities for professional development.

Qualifikationen

• Experience in Quality Engineering or Management within a regulated industry.
• Hands-on software development experience in regulated environments.
• Knowledge of Software as a Medical Device (SaMD).

Aufgaben

• Support quality management for software development and AI-related R&D.
• Drive risk management for medical device software.
• Oversee AI-enabled device software lifecycle and documentation.

Kenntnisse

Quality Engineering

Software Development

AI-enabled Products

Risk Management

Cybersecurity

Ausbildung

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

Tools

IEC 62304

ISO 14971

EU MDR

Jobbeschreibung

Shape the Future of Medical Innovation

Quality Management R&D Engineer – Software Development

As a 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.

Why Join Ambu?

Ambu is a global leader in medical device innovation, dedicated to improving patient care. It is advancing its ambition to achieve global leadership in endoscopy, and the new EndoIntelligence platform combines hardware, software, and AI to deliver integrated endoscopy solutions across the full procedure journey.

Key Responsibilities

• 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 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

Skills

• ABSc 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

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.