Software System Engineer

About the role

The Software System Engineer will translate stakeholder, user and regulatory needs into clear, testable and traceable software requirements for medical technology products. Working under general supervision, the role applies systems and software engineering practices in a regulated environment, collaborating with cross‑functional teams in an Agile setting.

Key responsibilities

• Translate stakeholder, user, product and regulatory needs into clear, testable, traceable system and software requirements.
• Define, analyze, review and maintain functional, interface, performance, safety and security requirements throughout the product lifecycle.
• Collaborate with architects and development teams to ensure requirements are correctly reflected in software architecture, design and integration strategies.
• Support Agile development by managing backlog, participating in sprint planning, design reviews and ensuring timely issue resolution.
• Drive investigation of technical issues, complaints and integration problems, performing root‑cause analysis and coordinating corrective actions.

Required profile

• Bachelor’s or Master’s degree in Software Engineering, Computer Science or a related field.
• Minimum 3 years of experience in systems or software engineering, preferably in regulated medical device development.
• Familiarity with IEC 62304, design controls and traceability in a regulated environment.
• Experience working in Agile cross‑functional teams and conducting requirements engineering.

Required skills

• Systems Engineering and Software Engineering
• Requirements Engineering, Traceability and Interface Definition
• System and Software Design, Systems Integration
• IEC 62304 and regulated software development lifecycle practices
• Agile development methods
• Root‑cause analysis and technical issue investigation
• Risk Management and Verification Planning
• Harness Engineering and AI‑assisted engineering workflows