R&D Process Engineer

• Design, implement, and optimize software development processes within R&D in accordance with relevant medical device standards (e.g. ISO 13485, MDR/FDA)
• Analyze effectiveness and efficiency of existing processes and manage process improvement and associated tool projects
• Work cross-functionally with R&D, Quality Management, Quality Assurance and other interfacing departments to maintain a compliant yet efficient development environment
• Ensure audit readiness and support internal and external audits related to R&D processes
• Align development processes within the Brainlab agile methodology
• Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across the organization

• University degree in engineering or life sciences preferred, but other degrees may be considered
• Professional experience in the design and development of medical devices or in leading process optimization initiatives
• Knowledge of medical device related standards and regulations such as FDA 21 CFR Part 820 and ISO 13485
• Flexibility to adjust processes to align with an evolving working model
• Solution orientation and a structured nature
• Strong communication and documentation skills and ability to work cross-functionally
• Fluent in written and spoken English, German is a plus

German is a plus

• 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