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Lead software system engineering in a high-impact digital health project. Rebuild of Coloplast’s app software – the digital backbone of the 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. Shape a stronger foundation for future features and compliance. Act as the bridge between stakeholders, technical specialists and regulatory requirements, translating needs into clear, testable and traceable design specifications – while also helping simplify and automate documentation setup.
Job Responsibility:
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
Requirements:
3+ years of experience with system engineering within SaMD or medical software development
Experience in authoring and reviewing software design documentation
Familiarity with IEC/EN 62304, ISO13485 and design control
Experience with software verification and risk management processes
Understanding of cybersecurity within medical software contexts
Proven experience in agile medtech development
Confident working with system design, software risk, and compliance