Ofertas › Brainlab
Brainlab · Waldkirch, Germany · 70.000 - 100.000 € per year
Salary: 70.000 - 100.000 € per year Requirements: Masters 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 record of leading complex medical device development projects across the full product lifecycle. Strong expertise in requirements engineering, design control, verification and validation, and risk management. Sound understanding of medical device regulations and standards, including MDR and FDA requirements. Strong analytical, technical, and problem-solving skills, 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 include experience with FDA submissions, clinical evaluation, usability engineering, human factors engineering, electrical or electromechanical systems, and technical leadership within cross-functional development teams. Passion for innovative medical technologies and a strong interest in intraoperative neuromonitoring (IONM), neurosurgery and spine surgery, thyroid and ENT surgery, neurophysiological monitoring, signal acquisition, and measurement systems. Responsibilities: Lead systems engineering activities 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 compliance activities in accordance with MDR, FDA, and other applicable regulatory requirements. Manage technical risks, drive problem-solving activities, and ensure successful project execution with respect to scope, timeline, and quality objectives. Serve as a technical expert and mentor within interdisciplinary development teams. Technologies: Support Marketing More: Dr. Langer Medical GmbH, based in Waldkirch, Ger