Software System Engineer (1-year maternity cover)

Coloplast; Humlebæk; On-site; 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

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Software System Engineer (1-year maternity cover)

Location: Humlebæk, DK

Job Family: Information Technology

Software System Engineer (1-year maternity cover)

Are you ready to lead software system engineering in a high-impact digital health project?

Coloplast has launched the world’s first ostomy leakage notification system – an innovative digital health solution that is already making a meaningful difference for our users.

We are looking for an experienced Software System Engineer to join our Digital Health team as a 1-year maternity cover, helping to evolve this breakthrough product and ensure it remains reliable, secure, and ready for the future.

Join our Digital Health team – a part of R&D

At our HQ in Humlebæk, you will join our Digital Health team, part of Chronic Care R&D. More than 20 engineers, architects, data scientists and product specialists work here in an agile environment on Coloplast’s pioneering digital platform. Here, you will collaborate closely with a highly skilled, senior team that brings deep technical expertise to the table.

We work in a hybrid setup, spending three days a week together at the office. It gives us the best of both worlds: time to collaborate, challenge ideas and co-create in person – balanced with flexibility and focus when working remotely.

Lead software system design in a regulated environment

As our Software System Engineer, you will play a key role in the ongoing evolution of Coloplast’s app software – the digital backbone of our innovative ostomy leakage notification system – you can read more about Heylo here: https://www.coloplastcharter.co.uk/heylo/ .

This is an exciting opportunity to contribute to ensuring continued quality, reliability, scalability, and compliance while enabling new features and enhancements that deliver value to users. You will help drive continuous improvement across requirements, documentation, development processes, and testing, ensuring a strong foundation for future innovation.

You will act as the bridge between stakeholders, technical specialists and regulatory requirements, translating needs into clear, testable and traceable design specifications; your experience with design control and risk management will enable you to be a trusted partner across departments.

You will, for example:

• 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

You may also expect 6-10 travel days per year, depending on project needs.

Bring strong documentation and systems thinking

With your proven experience in Agile medtech development, you are confident working with system design, software risk, and compliance. Your structured mindset helps create clarity in complex environments.

You communicate clearly, collaborate effectively, and enjoy working as part of a passionate and highly skilled team.

In addition, we imagine you:

• Have 3+ years of experience with system engineering within SaMD or medical software development
• Are experienced in authoring and reviewing software design documentation
• Are familiar with IEC/EN 62304, ISO13485 and design control
• Have worked with software verification and risk management processes
• Understand cybersecurity within medical software contexts

The position will remain open until a suitable candidate is found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark