Software System Engineer leading software system design for Coloplast's digital health project. Collaborating with engineers in a hybrid setup to enhance software documentation and requirements.
Responsibilities
Lead software system design in a regulated environment
Collaborate closely with senior team members in a hybrid setup
Define, manage and trace software requirements using Specification by Example and Gherkin
Run workshops and analyses with Product Management to refine stakeholder needs and requirements
Support with structuring and optimising design control documentation in collaboration with QA and RA
Requirements
3+ years of experience with system engineering within SaMD or medical software development
Experienced in authoring and reviewing software design documentation
Familiar with IEC/EN 62304, ISO13485 and design control
Worked with software verification and risk management processes
Understand cybersecurity within medical software contexts
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