Your tasks
- You coordinate and carry out verification and validation activities – in accordance with IEC 62304, ISO 13485, MDR and customer-specific requirements.
- You accompany requirements throughout their entire life cycle – from elicitation and consolidation to the derivation of test cases.
- You ensure clear traceability throughout the V-model between requirements at different levels and to test cases.
- You act as an interface between development, QA and customers – and incorporate V&V requirements into project planning at an early stage.
- You will be involved in reviews, design verifications and acceptance tests.
- You support the creation and maintenance of technical documentation and audits/inspections.
Your profile
- A degree in medical technology, computer science, natural sciences or a comparable qualification
- Knowledge of requirements engineering and common tools (e.g. Jira, Microsoft DevOps, etc.)
- Curiosity and openness for AI-supported technologies and automated processes
- Experience in the verification & validation of medical or safety-critical software incl. corresponding strategies and documentation
- Initial experience in test automation using various frameworks and test suites is an advantage
- Familiarity with regulatory requirements such as IEC 62304, ISO 14971, ISO 13485, MDR
- Structured, independent way of working, strong communication skills, analytical thinking and high attention to detail
- Willingness to undertake occasional business trips in the DACH region for customer workshops and selective on-site support.
- Excellent German and English language skills