Senior Project Engineer, Systems Engineering

Quick Facts

• Senior Systems Engineering role focused on medical device development lifecycle

Description

You will lead systems engineering activities for medical devices from concept development to product launch and sustaining engineering. The role focuses on defining and maintaining system requirements with end-to-end traceability across design, verification, and validation, while coordinating work across engineering, quality, regulatory, clinical, and manufacturing. You will also support regulatory submissions and compliance aligned with MDR and FDA requirements, managing technical risks to meet scope, timeline, and quality objectives.

Responsibilities

• Lead systems engineering across the full medical device development lifecycle
• Define, analyze, and maintain system requirements with end-to-end traceability
• Drive cross-functional collaboration among engineering, quality, regulatory, clinical, and manufacturing stakeholders
• Evaluate system concepts, architectures, and design solutions for performance, reliability, and patient safety
• Coordinate risk management, design reviews, verification and validation activities, and technical assessments
• Support regulatory submissions and compliance in line with MDR, FDA, and other applicable requirements
• Manage technical risks and solve technical issues to ensure successful project execution
• Serve as a technical expert and mentor within interdisciplinary development teams

Requirements

• Master’s degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or related technical/scientific discipline
• Several years of experience in medical device development, systems engineering, or R&D
• Proven track record leading complex medical device development projects end-to-end
• Expertise in requirements engineering, design control, verification and validation, and risk management
• Understanding of medical device regulations and standards, including MDR and FDA
• Strong analytical and problem-solving skills; ability to work in multidisciplinary teams
• Excellent communication, stakeholder management, and project leadership
• Fluent in English; German language skills advantageous

Benefits

• 30 vacation days plus December 24 and 31
• Flexible working hours
• Regular team and company events
• Internal fitness program
• Comprehensive training and continuing education opportunities