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# (Advanced / Senior) Project Engineer for Systems Engineering

- **Company:** Brainlab
- **Location:** Waldkirch, Germany
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Software Requirements Analysis, Verification and Validation (Software), Systems Architecture
- **Published:** October 14, 2026
- **Apply:** https://startup.jobs/advanced-senior-project-engineer-for-systems-engineering-brainlab-10431512

## About the Role

* 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 record of leading complex medical device development projects across the full product lifecycle.
 * Strong expertise in requirements 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

## Description

* 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.