Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Working hours

Shift work

Languages

English, German

Job source

startup.jobs

Tech stack

Systems Engineering Software Requirements Analysis Verification and Validation (Software) Systems Architecture

Job 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.

Requirements

• 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

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