(Advanced) Project Engineer - Neurosurgical Treatment Planning Systems Job at Brainlab (Munich)

Job Responsibility

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

Graduated from academic studies like sciences, engineering, computer science or mathematics
Several years of experience in medical device development, ideally in software (SaMD) or complex systems
Strong experience in FDA or MDR compliant documentation (e.g. ISO 14971, IEC 62304, ISO 13485) and post market surveillance of medical devices
A team worker, fluent verbal and written English communication skills, German knowledge is a plus
Strong stakeholder management and communication skills
Detail-oriented, analytical mindset with an ability to take ownership and work independently
Well-organized and clearly structured work style and a 'can do' mentality with a strong focus on quality and compliance
First practical experience in using e.g. Python or other tools for scripting, data analysis, or usage of AI tools for task or process automation
Experience in handling of radiological medical images like MRI/CT in DICOM format
Fluent in English
German is a strong plus

German knowledge is a plus
First practical experience in using e.g. Python or other tools for scripting, data analysis, or usage of AI tools for task or process automation
Experience in handling of radiological medical images like MRI/CT in DICOM format
German is a strong plus