(Senior) R&D Process Engineer

📋 Description

• Design, implement, and optimize R&D development processes per ISO 13485, MDR/FDA.
• Analyze process effectiveness and manage improvement and tool projects.
• Collaborate with R&D, Quality, and other departments for compliant development.
• Ensure audit readiness and support internal/external audits.
• Align processes with Brainlab agile methodology.
• Provide process training and coaching to R&D colleagues.

🎯 Requirements

• University degree in engineering or life sciences preferred.
• Experience in medical device design or process optimization initiatives.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Flexibility to adapt processes to evolving working model.
• Strong communication, documentation, and cross-functional skills.
• Fluent English; German is a plus.

🎁 Benefits

• 30 vacation days plus Dec 24 and 31.
• Flexible working hours and hybrid work within Germany.
• Bike leasing via BikeLeasing.
• Parking garage and safe bike storage.
• Subsidized company restaurant and in-house cafes.
• Fitness program, events, and training opportunities.