Auf einen Blick
- Aufgaben: Sichere die Qualität von Software und KI-gestützten Medizinprodukten über den gesamten Lebenszyklus.
- Unternehmen: Ambu, ein globaler Innovator im Bereich medizinischer Geräte.
- Vorteile: Dynamisches, internationales Umfeld mit vielfältigen Entwicklungsmöglichkeiten und umfangreichen Vorteilen.
- Weitere Informationen: Werde Teil eines Teams, das Vielfalt schätzt und Innovation fördert.
- Warum dieser Job: Gestalte die Zukunft der Gesundheitsversorgung mit innovativen Technologien und einem starken Team.
- Qualifikationen: Mindestens 5 Jahre Erfahrung in Qualitätsmanagement im regulierten Umfeld.
Das prognostizierte Gehalt liegt zwischen 50000 - 70000 € pro Jahr.
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.
Key Responsibilities
- Act as the Quality Management partner for software development and AI‑related R&D projects.
- Drive and support risk management activities for software‑based and software‑enabled medical devices.
- Ensure compliance across the software life cycle, including development, verification, validation, release, maintenance, and change control.
- Support the integration of cybersecurity into product development and maintenance processes.
- Provide 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.
Qualifications
- ABSc or MSc in Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering, or a related technical discipline.
- 5 + years of experience in Quality Engineering / Quality Management within the medical device, digital health, health software, or a highly regulated industry.
- Hands‑on experience working with software development projects in regulated environments.
- Solid knowledge of Software as a Medical Device (Sa MD) 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 safety and cybersecurity risks.
- 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.
Benefits
- A dynamic, diverse and international work environment.
- Opportunities for personal and professional development.
- A wide range of benefits – professional, social, and financial.
- Collaboration with a team that values different perspectives and fosters innovation.
Ambu is a global leader in medical device innovation, dedicated to improving patient care.
The company’s Zoom Ahead strategy focuses on endoscopy solutions that combine hardware, software, and AI to deliver integrated endoscopy solutions across the full procedure journey.
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.
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