R&D Process Engineer - Software Development

• Design, implement, and optimize software development processes within R&D in accordance with relevant medical device standards (e.g., IEC 62304, ISO 13485, ISO 14971, MDR/FDA)
• Work cross-functionally with R&D, Quality Management, Quality Assurance to maintain a compliant yet efficient development environment
• Ensure audit readiness and support internal and external audits related to R&D processes
• Align software development processes within the Brainlab agile methodology
• Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across the organization
• Align and integrate tools that support process automation and collaboration within R&D

• University degree Computer Science or equivalent
• Knowledge of IEC 62304 and its successful implementation in organizations
• Knowledge of other medical device software related standards and regulations such as FDA 21 CFR Part 820 and ISO 13485 desired
• Solution orientation and a structured nature
• Strong communication and documentation skills and ability to work cross-functionally
• Experience in software development in a regulated industry (medical devices preferred)
• Basic to intermediate proficiency in programming languages (e.g. Python, Java) and/or experience with scripting and automation tools to enhance process efficiency
• 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
• 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