(Advanced) Project Engineer - Neurosurgical Treatment Planning Systems

About the Position

We are seeking a dedicated (Advanced) Project Engineer for the development of our neurosurgical treatment planning systems. This role is pivotal in ensuring medical device documentation, system validation, risk management, and regulatory compliance throughout the entire development process and product lifecycle, including post-market surveillance.

Responsibilities

• 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

Requirements

• 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
• 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 with a “can do” mentality and 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 radiological medical images like MRI/CT in DICOM format

Nice to Have

• German language skills
• Experience in teamwork, stakeholder management, and analytical mindset

We Offer

• A mutually-supportive, international team
• Meaningful work with a lasting impact on medical technology
• 30 vacation days, plus December 24th and December 31st
• Flexible working hours as well as hybrid work model within Germany
• Bike leasing via cooperation partner "BikeLeasing"
• Parking garage and safe underground bike storage
• Award-winning subsidized company restaurant and in-house cafes
• Variety-rich fitness program in our ultra-modern 360m² company gym
• Regular after-work, team, and company events
• Comprehensive training and continuing education opportunities

About the Company

At the forefront of health technology for over 35 years, Munich-based Brainlab digitizes medical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.

Our key to success is our creative, talented, and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values: curious, authentic, and useful.

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.

Contact person: Elisabeth Karro

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