(Advanced / Senior) Project Engineer for Systems Engineering

Lead systems engineering throughout the medical device development lifecycle, from concept development to product launch and sustaining engineering. Define, analyze, and maintain system requirements while ensuring end-to-end traceability through design, verification, and validation. Drive cross-functional collaboration between engineering, quality, regulatory, clinical, and manufacturing stakeholders. Evaluate technical concepts, system architectures, and design solutions to ensure product performance, reliability, and patient safety. Coordinate risk management, design reviews, verification and validation activities, and technical assessments. Support regulatory submissions and activities compliance in accordance with MDR, FDA, and other applicable regulatory requirements. Manage technical risks, drive problem-solving, and ensure successful project execution with respect to scope, timeline, and quality objectives. Serve as a technical expert and mentor within interdisciplinary development teams.

Qualifications Master's degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical or scientific discipline. Several years of experience in medical device development, systems engineering, or R&D. Proven track of leading complex medical device development projects across the full product lifecycle. Strong expertise in engineering, design control, verification & validation, and risk management. Sound understanding of medical device regulations and standards, including MDR and FDA requirements. Strong analytical, technical, and problem-solving skills combined with the ability to work effectively in multidisciplinary teams. Excellent communication, stakeholder management, and project leadership capabilities. Fluent in English; German language skills are an advantage. Preferred Qualifications: Experience with FDA submissions, clinical evaluation, usability engineering, human factors engineering, electrical or electromechanical systems, and technical leadership within cross-functional development teams. The ideal candidate is passionate about innovative medical technologies and has a strong interest in: Intraoperative Neuromonitoring (IONM), Neurosurgery and Spine Surgery, Thyroid and ENT Surgery, Neurophysiological Monitoring, signal acquisition, and measurement systems

A dynamic-supportive, international team Meaningful work with a lasting impact on medical technology 30 vacation days, plus December 24th and December 31st Flexible working hours Regular team, and company events Internal company fitness program Comprehensive training and continuing education opportunities offered by Brainlab TOP 100 innovator and employer of the future 2022