Software System Engineer - build healthcare that matters

Jobs2Web; Denmark; Hybrid; DKK 700,000 - 900,000; Full time

Job summary

Coloplast is seeking a Software System Engineer to lead the rebuild of Heylo, the digital backbone of its ostomy leakage notification system. You will focus on needs elicitation, requirement creation, design control, and risk management within SaMD in a regulated medical device context.

You’ll bridge stakeholders, regulatory requirements, and technical teams, drafting traceable design specs while improving documentation automation and audit readiness.

Qualifications

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

Responsibilities

• Run workshops and analyses with Product Management to refine needs.
• Define and trace software requirements using Specification by Example and Gherkin.
• Lead software risk management and collaborate on cybersecurity with the Software Architect.
• Support documentation workflow improvements across the development process.

Skills

System engineering

Agile medtech

Regulatory understanding

Job description

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Software System Engineer - build healthcare that matters

Location: Humlebæk, DK

Job Family: Information Technology

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. Join us and help 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 rebuild of Coloplast’s app software – the digital backbone of our innovative ostomy leakage notification system - Heylo. This new version is a major initiative aimed at improving user experience, structure, maintainability, testability, and documentation quality across everything from documentation to code and the product UI. You will help shape a stronger foundation for future features and compliance.

This position is a system engineering position, focused on needs elicitation, requirement creation and maintenance, design control, and risk management, rather than a software engineering position focused on writing the software itself.

You will act as the bridge between stakeholders, technical specialists and regulatory requirements, translating needs into clear, testable and traceable design specifications – while also helping us simplify and automate our documentation setup.

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
• Is familiar with IEC/EN 62304, ISO13485 and design control
• Have worked with software verification and risk management processes
• Understand cybersecurity within medical software contexts

Interested?

If you would like to know more about this position, please contact Head of Digital Health, Megan Dyton, at [e-mail]. We continuously review applications, so we encourage you to apply as soon as possible.

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