QM R&D Engineer - Software Development
On-site · Augsburg, Bavaria, Germany
Augsburg, Bavaria, GermanyOn-siteFull TimeMid LevelMasters DegreeLarge
Type
Full Time
Level
Mid Level
Education
Masters Degree
Company size
Large
Job Summary
QM R&D Engineer – Software Development role focused on quality and compliance in medical device software and AI-enabled solutions. Drive quality management across software development projects, support risk management, integrate cybersecurity into product development, oversee AI-enabled medical device software lifecycle controls, documentation, traceability and change management, and contribute to design controls, lifecycle management, design changes, and post-market surveillance across global sites.
Required Qualifications
- 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
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