(Senior) Systems Engineer - Spine & Trauma Medical Solution  

As (Senior) Systems Engineer, working in the Medical Device Team of Brainlab’s Spinal Research and Development division, you will make a crucial impact on one of the world’s leading portfolios for digitized spine and trauma surgeries: Jointly with your team you will take  responsibility for all steps needed to bring our cutting edge medical device portfolio for a variety of clinical use scenarios into the highly regulated medical device market. 

As a natural team player with good communication skills and with your strong interest in agile development, you will be part of a caring, multidisciplinary, highly skilled development team. The portfolio that you and your team take care of, involves a multitude of fascinating components, like digital planning, surgical navigation, medical image acquisitions, robotic assistance or augmented reality on various computer platforms including cloud solutions. 

As (Senior) Systems Engineer being a part of this team, your work includes all steps to bring a medical device portfolio to the market, focusing on integration, verification, validation on system (use case) level. 

Your tasks include: 

• working in a LeSS environment as part of a cross-functional team, collaborating closely with Product Owners and departments such as Quality Assurance, Usability, and other teams involved in the solutions 
• working on integration, verification, validation on system (use case) level to bring spinal portfolio solutions into the highly regulated medical device market following MDR and FDA regulations 
• working with the clinical and regulatory affairs team, e.g. for clinical studies or FDA applications 

• Graduate of a technical or scientific course of study (e.g. mechanical engineering, medical technology, physics, medicine, informatics, ...) or related discipline or equivalent working experience 
• Several years of professional experience in development in a regulated industry (medical devices preferred) 
• Natural team player, strong communication and documentation skills and ability to work cross-functionally 
• Fluent in written and spoken English, German is a plus 

Bonus Qualifications 

• Proficiency in programming languages (e.g. Python, Java) and/or experience with scripting, automation tools and/or AI to enhance process efficiency 
• Experience with working scientifically (e.g. literature appraisal and writing, research project organization, data science / statistics knowledge) 
• Knowledge in regulatory requirements (ISO 13485, ISO 14971, IEC 62304, MDR, FDA 21 CFR Part 11) 

• A mutually-supportive, international team
• Meaningful work with a lasting impact on medical technology
• 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

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary. 

Contact person: Elisabeth Karro