(Advanced) Project Engineer - Neurosurgical Treatment Planning Systems

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 a...