Coloplast

Software System Engineer

Coloplast

full-time

Posted on:

Location Type: Hybrid

Location: Humlebæk • Denmark

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Tech Stack

Cyber Security

About the role

  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
system engineeringsoftware design documentationsoftware verificationrisk managementSpecification by ExampleGherkindesign controlcybersecurity
Soft skills
collaborationleadershiporganizational skillscommunication
Certifications
IEC/EN 62304ISO 13485