Systems Engineer (Medical Devices, Temporary, Remote)

Job summary

This role involves supporting the development of innovative solutions in a creative R&D environment, focusing on systems engineering and design control for healthcare products. The position is temporary for 12 months and emphasizes collaboration with various teams to enhance product quality and compliance.

Qualifications

• Degree in engineering or a related technical field.
• Experience in systems engineering and design control within a regulated environment, preferably in medical devices.
• Familiarity with risk management, requirements engineering, and traceability.
• Proven ability to work cross-functionally with R&D, Test, Quality, and Regulatory teams.
• Strong analytical and communication skills.
• Experience with Polarion or similar Application Lifecycle Management (ALM) tools is a plus.

Responsibilities

What we offer

A collaborative and educational environment focused on quality and professional standards, providing real responsibilities and opportunities to develop skills in systems engineering and regulated product development.

• Lead design control and product risk management activities in development projects.
• Convert stakeholder needs into clear, high-quality system and subsystem requirements with full traceability.
• Manage systems engineering documentation, including design inputs/outputs and risk documentation.
• Assist in design verification and validation planning and execution in partnership with Test Engineering.
• Engage in design reviews, change control, and impact assessments.
• Ensure adherence to relevant regulatory and quality standards (e.g., MDR, FDA, ISO 13485, ISO 14971).
• Collaborate with cross-functional project teams to ensure timely project delivery.