Systems Engineer

Role Overview

• Drive and support design control and product risk management activities in development projects.
• Translate stakeholders into clear, high-quality system and subsystem requirements with end-to-end traceability.
• Own and contribute to systems engineering documentation, including design input/output, product description, and risk documentation.
• Support design verification and validation planning and execution in close collaboration with Test Engineering.
• Participate in design reviews, change control, and impact assessments.
• Ensure compliance with applicable regulatory and quality requirements (e.g. MDR, FDA, ISO 13485, ISO 14971).
• Collaborate closely with cross-functional project teams to support timely project execution.

Requirements

• Degree in engineering or a similar technical discipline.
• Experience with systems engineering and design control in a regulated environment (medical devices are an advantage).
• Knowledge of risk management, requirements engineering, and traceability.
• Experience working cross-functionally with R&D, Test, Quality, and Regulatory stakeholders.
• Strong analytical and communication skills.
• Experience with Polarion or similar ALM tools is an advantage.

Benefits

• A 12-months temporary position and a permanent position in a collaborative and learning environment with strong focus on quality, high professional standards, good sparring and learning.
• You will get real responsibility from the start and the opportunity to build strong capability in systems engineering and regulated product development.
• You will collaborate closely with experienced colleagues in Systems Engineering, Test Engineering, and Product Development.