To strengthen our development team, we are looking for a dedicated (Advanced) Project Engineer for the development of our treatment planning medical device systems. The focus of this position is on medical device documentation, system validation, risk management and regulatory compliance throughout the entire development process & product lifecycle incl. post market surveillance.
Your responsibilities include:
- Leading regulatory and quality-related activities within development projects to ensure compliance with applicable standards and regulations (e.g., MDR, ISO 13485, IEC 62304, IEC 62366, ISO 14971)
- Managing and driving verification and validation (V&V) activities, ensuring completeness, traceability, and audit readiness
- Ownership for technical documentation, including design history files, risk management files and clinical evaluation
- Establishing and maintaining documentation processes and templates aligned with internal and external requirements
- Acting as a subject matter expert for regulatory and documentation topics within cross-functional project teams
- Coordination with Regulatory Affairs and Quality Assurance to support submissions, audits, and inspections
- Management of post market surveillance (PMS) activities
- Ensuring end-to-end traceability from requirements through design, verification, validation, and release
- Driving continuous improvement of development and documentation processes, including tool chains and workflows
- Collaborating closely with internal teams, clinical partners, and external stakeholders
