Quality Management R&D Engineer Software Development

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

Benefits dieser Stelle

Collaborative team environment

Opportunities for personal and professional development

Dynamic and diverse work environment

Zusammenfassung

Ambu A/S is seeking a Quality Management R&D Engineer for Software Development in Augsburg, Germany. This role ensures compliance with global regulatory and quality standards for software and AI-enabled medical device solutions.

You will support software development projects, driving continuous improvement from concept to market. The ideal candidate holds a BSc or MSc in a relevant field and has experience in quality engineering within regulated industries, especially health software and AI.

The company offers a collaborative team environment and opportunities for professional development.

Qualifikationen

• Work experience in the medical devices or highly regulated industry.
• Understanding of risk management for software-based medical devices.

Aufgaben

• Provide quality management support for software development projects.
• Drive and support risk management activities for medical devices.
• Integrate cybersecurity requirements into development processes.
• Offer quality oversight for AI-enabled medical device software.

Kenntnisse

Quality engineering/management experience

Hands-on experience with software development projects

Knowledge of Software as a Medical Device (SaMD)

Understanding of risk management

Familiarity with AI/ML regulatory expectations

Ausbildung

BSc or MSc in Software Engineering or related field

Tools

Standards expertise (IEC, ISO, EU MDR)

Jobbeschreibung

Quality Management R&D Engineer – Software Development

Quality Management R&D Engineer Software Development Qualität für Medical Innovation in Augsburg, Germany.

Shape the future of medical innovation by ensuring software and AI‑enabled medical device solutions are developed, maintained, and improved in compliance with global regulatory and quality requirements. Support software development projects and drive continuous improvement across the full product life cycle, from concept to post‑market activities.

Key Responsibilities

• Provide quality management support for software development and AI‑related R&D projects.
• Drive and support risk management activities for software‑based and software‑enabled medical devices.
• Integrate cybersecurity requirements into product development and maintenance processes.
• Offer quality oversight for AI‑enabled medical device software, including lifecycle controls, documentation, traceability, and change management.
• Support design control, life cycle management, design changes, and post‑market surveillance activities.

Suggested Candidate Profile

• BSc or MSc in Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering, or a related technical discipline.
• Work experience in quality engineering/management within medical devices, digital health, health software, or another highly regulated industry.
• Hands‑on experience 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 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 EU AI Act implications for high‑risk AI systems in health/medtech is a strong advantage.

We Offer

• A collaborative team that values diversity and innovation.
• Opportunities for personal and professional development.
• A dynamic, diverse and international work environment.
• A range of employee benefits—including professional, social, and financial perks.

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.