Software System Engineer – 1 Year Maternity Cover

About the role

Lead software system engineering for Coloplast’s innovative ostomy leakage notification system as a 1‑year maternity cover. You will join the Digital Health team in Humlebæk, working in an agile, hybrid environment to ensure the product remains reliable, secure and future‑ready.

Key responsibilities

• Run workshops, interviews and analyses with Product Management to refine stakeholder needs and requirements.
• Define, manage and trace software requirements using Specification by Example and Gherkin, aligning them with automated testing.
• Lead software risk management and collaborate on cybersecurity with the Software Architect and Technical Solution Owner.
• Support structuring and optimizing design‑control documentation together with QA and Regulatory Affairs, ensuring audit readiness.
• Improve integration of automated documentation workflows across the development process.

Required profile

• 3+ years of experience in system engineering for SaMD or medical software development.
• Proven ability to author and review software design documentation.
• Familiarity with IEC/EN 62304, ISO 13485 and design‑control processes.
• Experience with software verification, risk management and cybersecurity in a medical context.
• Strong documentation and systems‑thinking mindset, comfortable in an Agile med‑tech environment.

Required skills

• Specification by Example
• Gherkin
• Software risk management
• Cybersecurity for medical software
• IEC/EN 62304 compliance
• ISO 13485 compliance