Systems Engineer – Medical Device Development

About the role

Join a creative R&D environment developing innovative solutions for people with intimate healthcare needs worldwide. Work alongside knowledgeable specialists and project managers in a dynamic department.

Key responsibilities

• Drive and support design control and product risk management activities in development projects.
• Translate stakeholder needs 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.

Required profile

• Degree in engineering or a similar technical discipline.
• Experience with systems engineering and design control in a regulated environment (medical devices advantageous).
• 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.

Required skills

• Polarion (or similar ALM tool)
• Risk management
• Requirements engineering
• Traceability

What we offer

• Collaborative and learning environment with a strong focus on quality.
• Real responsibility from the start and opportunity to build capability in systems engineering and regulated product development.
• Close collaboration with experienced colleagues in Systems Engineering, Test Engineering, and Product Development.