Senior QM R&D Engineer - Soffware Development
On-site · Augsburg, Bavaria, Germany
Augsburg, Bavaria, GermanyOn-siteFull TimeSenior LevelBachelors DegreeLarge
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Large
Job Summary
Senior QM R&D Engineer for Software Development who will lead quality management and regulatory compliance across the software lifecycle for AI-enabled medical devices, acting as the Quality partner for software projects, driving risk management, cybersecurity integration, design controls, and post-market surveillance across global sites.
Required Qualifications
- 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 regulated medical/health software
- Hands-on experience with software development projects in regulated environments
- Solid knowledge of SaMD and/or software embedded in medical devices
- Experience with AI-enabled products or regulatory expectations for AI/ML-based medical software
- Strong understanding of risk management including safety and cybersecurity risk
- Experience with global cross-functional teams and translating quality requirements into actionable guidance
- Knowledge of 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 in health/medtech
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