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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.
Job Responsibility:
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
Requirements:
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
Nice to have:
German is a plus
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)
What we offer:
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
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