Brainlab
Healthcare
(Advanced)ProjectEngineer-NeurosurgicalTreatmentPlanningSystems
Neural analysis suggests this role is
optimal for mid candidates.
“(Advanced) Project Engineer - Neurosurgical Treatment Planning Systems at Brainlab. Skills: Medical device development, Regulatory compliance, Documentation, Risk management. Lead regulatory and quality-related activities. Manage verification and validation (V&V) activities”
Industry & Context.
Analytical mindset
What They're Looking For.
Must Have
Academic studies in sciences, engineering, computer science or mathematics, Several years of experience in medical device development, Experience in FDA or MDR compliant documentation, Experience in post market surveillance of medical devices, Fluent verbal and written English communication skills, Stakeholder management skills, Analytical mindset, Well-organized and clearly structured work style, First practical experience with Python or other scripting tools, Experience handling radiological medical images like MRI/CT in DICOM format
Nice to Have
Ideally in software (SaMD) or complex systems, German knowledge is a plus, Fluent in German is a plus
What You'll Do.
Lead regulatory and quality-related activities
Manage verification and validation (V&V) activities
Own technical documentation
Establish and maintain documentation processes
Act as subject matter expert
Coordinate with Regulatory Affairs and Quality Assurance
Manage post market surveillance (PMS) activities
Ensure end-to-end traceability
Drive continuous improvement of development processes
Drive continuous improvement of documentation processes
Collaborate with internal teams
Collaborate with clinical partners
Collaborate with external stakeholders
How You'll Work.
Team & Collaboration
Cross-functional project teams; Internal teams; Clinical partners; External stakeholders
Communication Scope
Verbal communication; Written communication
Process & Methodology
Project management
Full Job Description
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. 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 continuo
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