(Advanced / Senior) Project Engineer for Systems Engineering

In this role you lead systems engineering across the medical device development lifecycle, from concept to launch and sustaining engineering. You’ll ensure end-to-end traceability of requirements and drive cross-functional collaboration among engineering, quality, regulatory, clinical, and manufacturing teams. You’ll evaluate architectures to guarantee performance, safety, and reliability, while coordinating risk management and verification/validation activities. You’ll support regulatory submissions and help ensure compliance with MDR and FDA requirements, shaping innovative medical technologies at Dr. Langer Medical within the Brainlab group.

• 30 vacation days
• flexible working hours
• regular team events
• internal company fitness program
• comprehensive training and continuing education opportunities
• TOP 100 innovator and employer of the future 2022

• Lead system-level activities across concept development, validation, and product launch
• Define and maintain system requirements with end-to-end traceability through design, verification, and validation
• Coordinate cross-functional collaboration among engineering, quality, regulatory, clinical, and manufacturing teams
• Assess concepts, architectures, and solutions for performance, reliability, and patient safety
• Coordinate risk management, design reviews, verification/validation, and technical assessments
• Support regulatory submissions and ensure compliance with MDR, FDA, and other regulatory requirements
• Manage technical risks and drive problem-solving to meet scope, schedule, and quality targets
• Serve as technical expert and mentor within interdisciplinary development teams

• Master’s degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or related field
• Several years of experience in medical device development, systems engineering, or R&D
• Proven track record leading complex medical device development across the product lifecycle
• Strong expertise in requirements engineering, design control, verification & validation, and risk management
• Solid understanding of medical device regulations and standards (MDR, FDA)
• Strong analytical, technical, and problem-solving skills; effective in multidisciplinary teams
• Excellent communication, stakeholder management, and project leadership
• Fluent in English; German is an advantage

• cross-functional collaboration
• strong communication
• stakeholder management
• requirements engineering
• design control
• verification & validation