(Senior) Systems Engineer Spine & Trauma Medical Solution

Brainlab; München; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical technology firm in Munich is seeking a (Senior) Systems Engineer to drive the development of innovative medical devices. You will collaborate with a skilled, multidisciplinary team to ensure compliance with industry regulations and enhance patient treatments. The role involves integration, verification, and validation tasks, and requires a graduate in a relevant field with several years of experience in a regulated industry. A supportive work environment and various benefits are offered, including flexible hours and a hybrid work model.

Leistungen

30 vacation days

Flexible working hours

Bike leasing

Company restaurant

Fitness program

Continuing education opportunities

Qualifikationen

• Graduate from a technical or scientific course of study or equivalent experience.
• Several years of professional experience in development in a regulated industry.
• Fluent English with German as a plus.

Aufgaben

• Collaborate within a cross-functional team in a LeSS environment.
• Work on integration, verification, validation on system level for spinal portfolio solutions.
• Engage with clinical and regulatory affairs teams regarding studies or applications.

Kenntnisse

Team player

Strong communication skills

Documentation skills

Fluent in English

Proficiency in Python or Java

Ausbildung

Graduate in mechanical engineering, medical technology, physics, medicine, informatics

Jobbeschreibung

Overview

Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.

Role

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.

Responsibilities

• 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, etc.) 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)

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

How to Apply

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

Contact person: Elisabeth Karro