(Advanced) Project Engineer – Cranial Navigation (R&D) Risk Management

Join Brainlab’s R&D team for Cranial Navigation and help ensure the safety and reliability of cutting-edge technologies used in cranial surgery worldwide.

As a Risk Management Consultant, you will play a key role in integrating risk management into the development of complex medical systems. Working closely with multidisciplinary development teams, you will support the identification, evaluation, and mitigation of risks across our cranial navigation portfolio. Your work will combine systems thinking with regulatory and clinical perspectives, ensuring that safety considerations are embedded throughout the entire product lifecycle.

You will collaborate with engineers, clinical experts, and product teams to maintain a holistic view of our navigation ecosystem, including platforms, instruments, and connected technologies. In this role, you will act as a trusted advisor for development teams and contribute to building efficient and robust risk management processes within the organization.

Alongside your risk management responsibilities, the role includes additional R&D project engineering tasks depending on your interests and strengths.

Responsibilities as Risk Management Consultant

Risk Management & Systems Engineering

• Act as a central contact for risk-related topics within the Cranial Navigation R&D organization
• Support development teams in identifying, analyzing, and mitigating risks throughout the medical device lifecycle
• Contribute to the development and execution of risk management strategies for complex medical systems and their interfaces
• Apply systems thinking to evaluate interactions between devices, accessories, clinical workflows, and users
• Support human factors engineering bringing the risk management perspective
• Support the creation, review, and maintenance of risk management documentation in accordance with regulatory requirements
• Coordinate use case–driven risk analyses together with domain experts and use case owners
• Drive the Polarion transition of Cranial Navigation risk management portfolio from concept to implementation together with domain and clinical experts.

Collaboration & Consulting

• Provide consulting and guidance to development teams on risk analysis approaches and best practices
• Review and support harmonize risk documentation across projects to ensure consistency and high quality standards
• Collaborate with internal stakeholders across R&D, Quality Management, Regulatory Affairs, and Product Management
• Contribute to cross-portfolio alignment of risk management topics with other Brainlab product areas
• Support the continuous improvement of risk management structures, tools, and documentation processes

Product Lifecycle Support

• Support the maintenance of risk documentation for released products, including updates driven by Post Market Surveillance or compatibility changes
• Contribute to ensuring compliance with relevant standards and regulations, including ISO 14971 and related frameworks

Responsibilities as (Advanced) Project Engineer

• Medical device development and documentation on system level
• Contribute to medical device development and system-level documentation within the Cranial Navigation product line.