(Senior) Systems Engineer Spine & Trauma Medical Solution

As (Senior) Systems Engineer working in the Medical Device Team of Brainlabs Spinal Research and Development division you will make a crucial impacton one of the worlds 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

Qualifications :

• Graduate of a technical or scientific course of study (e.g. mechanical engineering medical technology physics medicine informatics ...)or related disciplineor 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)

Additional Information :

• 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

Remote Work :

No

Employment Type :

Full-time

Key Skills
Feed,Apache Commons,Maintenance,Business Support,Clinical
Experience: years
Vacancy: 1