Hybrid Software System Engineer

Posted last week

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About the role

  • 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

Benefits

  • Flexible working arrangements
  • Professional development opportunities

Job title

Software System Engineer

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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