(Senior) R&D Process Engineer

As a (Senior) Process Engineer in Brainlab’s R&D Office, you design, implement, and optimize development workflows to meet medical device standards. You work with cross-functional teams to maintain compliant yet efficient product delivery and foster agile, innovative practices. You ensure audit readiness and guide process improvements across R&D, Quality Management, and Product Management. This role offers meaningful impact on Brainlab’s digital healthcare ecosystem and opportunities to shape development practices at scale.

• 30 vacation days
• flexible working hours
• hybrid work model in Germany
• bike leasing
• subsidized company restaurant
• comprehensive training opportunities

• Design, implement, and optimize development processes in line with medical device standards (ISO 13485, MDR/FDA)
• Analyze process effectiveness and drive improvement projects and tool initiatives
• Collaborate with R&D, Quality Management, Quality Assurance and related departments to maintain compliance and efficiency
• Ensure audit readiness and support internal/external audits of R&D processes
• Align processes with Brainlab’s agile methodology
• Provide process training and facilitate knowledge sharing across the organization

• University degree in engineering or life sciences preferred, but other degrees may be considered
• Professional experience in design and development of medical devices or leading process optimization initiatives
• Knowledge of medical device standards/regulations such as FDA 21 CFR Part 820 and ISO 13485
• Flexibility to adapt processes to changing working models
• Solution-oriented and structured thinker
• Strong communication and documentation skills with cross-functional collaboration
• Fluent in written/spoken English; German a plus

• strong communication
• cross-functional collaboration
• solution orientation
• ISO 13485
• MDR/FDA
• FDA 21 CFR Part 820