Systems Engineer

Job summary

This role involves contributing to the development of innovative solutions in a creative R&D environment focused on intimate healthcare needs. The Systems Engineer will play a crucial role in integrating systems engineering approaches to enhance product development.

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 collaboratively with R&D, Test, Quality, and Regulatory teams.
• Strong analytical and communication skills.
• Experience with Polarion or similar Application Lifecycle Management tools is a plus.

Responsibilities

What we offer

• Lead and support design control and product risk management activities in development projects.
• Convert stakeholder needs into clear, high-quality system and subsystem requirements with end-to-end traceability.
• Manage systems engineering documentation, including design inputs/outputs, product descriptions, 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 compliance with relevant regulatory and quality standards (e.g., MDR, FDA, ISO 13485, ISO 14971).
• Collaborate with cross-functional project teams to ensure timely project delivery.
• Opportunities for professional growth in a collaborative environment focused on quality and high standards.
• Real responsibilities from the outset, with a chance to develop strong capabilities in systems engineering and regulated product development.