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System Engineer – Software as a Medical Device

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3Shape

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Location:
Denmark , Copenhagen

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

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Job Description:

In the TRIOS Dx team, we are looking for a highly skilled System Engineer to join our R&D team developing next‑generation Software as a Medical Device (SaMD) solution. In this role, you will bridge software engineering, system architecture, clinical requirements, and regulatory expectations to ensure our products are safe, compliant, and impactful for patients and healthcare professionals. You will play a key part in shaping system architecture, defining requirements, and ensuring end‑to‑end traceability and risk control throughout the product lifecycle.

Job Responsibility:

  • Define, maintain, and evolve system architecture for SaMD products, ensuring alignment with clinical and business needs
  • Translate user needs, clinical workflows, and product strategy into system-level requirements and specifications
  • Collaborate with cross-functional teams — software, QA, data science, design, risk management, and clinical stakeholders — to ensure a cohesive and compliant system design
  • Drive interface definitions, data flow specifications, and subsystem interactions
  • Ensure traceability, verification, and validation across the design control framework
  • Guide engineering teams in applying regulatory expectations such as IEC 62304, ISO 14971, IEC 82304‑1, and relevant cybersecurity guidance
  • Participate in risk analysis, safety architecture development, and hazard mitigation strategies
  • Support planning and execution of system-level verification and validation activities
  • Contribute to continuous improvement of our system engineering practices and design control processes

Requirements:

  • Bachelor’s or Master’s degree in Software Engineering, Electrical Engineering, Computer Science, Systems Engineering, or related field
  • Experience in complex system architecture or system engineering within regulated industries
  • Strong understanding of software lifecycle management, requirements engineering, and interface design
  • Experience working with risk management and design control principles
  • Ability to structure complex clinical and technical problems into clear, testable system requirements
  • Strong communication skills and comfort working in cross‑functional environments

Nice to have:

  • Experience in medical devices, SaMD, digital health, diagnostics, or healthcare technology
  • Familiarity with IEC 62304, ISO 14971, ISO 13485, IEC 82304‑1, or FDA SaMD guidelines
  • Experience with cybersecurity practices and standards (e.g., ISO/IEC 27001, FDA Cybersecurity guidance)
  • Knowledge of cloud‑based and/or AI-enabled medical software architectures
  • Experience with requirements management tools (e.g., Polarion, Jama, DOORS)
What we offer:
  • An opportunity to improve the comfort and treatment of patients by making the technology of tomorrow
  • A rare opportunity to participate in something radically new, both scientifically and commercially
  • An attractive work environment in an informal atmosphere, among best-in-class colleagues
  • Competitive employment terms and benefits and a good work-life balance including remote work for up to 2 days per week

Additional Information:

Job Posted:
March 21, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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