Hybrid Software System Engineer – MedTech (1-Year)

Coloplast; Humlebæk; Hybrid; DKK 600,000 - 750,000; Full time

Job summary

Coloplast is seeking a Software System Engineer for a 1-year maternity cover in Humlebæk, DK. You will lead the evolution of the digital health platform, ensuring reliability, security, and regulatory compliance in a hybrid, office-plus-remote setting.

You bring 3+ years in SaMD or medical software, strong experience with design control, risk management and cybersecurity, and a collaborative, senior team mindset. Travel 6–10 days/year may be required.

Qualifications

• 3+ years of system engineering in SaMD or medical software development.
• Experience authoring and reviewing software design documentation.
• Familiarity with IEC/EN 62304, ISO13485 and design control.
• Experience with software verification and risk management processes.
• Understanding cybersecurity within medical software contexts.

Responsibilities

• Run workshops, interviews and analyses with Product Management to understand and refine stakeholder needs and requirements.
• Define, manage and trace software requirements using Specification by Example and Gherkin, ensuring full alignment with automated testing.
• Lead software risk management and collaborate on cybersecurity with the Software Architect and Technical Solution Owner.
• Support with structuring and optimising design control documentation in close collaboration with QA and RA, supporting continuous improvement and audit readiness.
• Support with improvements to the integration of automated documentation workflows across the development process.

Skills

System engineering

Regulatory compliance

Cybersecurity awareness

Software design

Job description

Coloplast is seeking a Software System Engineer for a 1-year maternity cover in Humlebæk, DK. You will lead the evolution of the digital health platform, ensuring reliability, security, and regulatory compliance in a hybrid, office-plus-remote setting.

You bring 3+ years in SaMD or medical software, strong experience with design control, risk management and cybersecurity, and a collaborative, senior team mindset. Travel 6–10 days/year may be required.