R&d Software Design Control Specialist - Medical Devices

Agilent Technologies

Glostrup, Denmark
Fully remote
Experience with design control activities
Knowledge of medical device regulatory requirements
Ability to convert user needs to product requirements
This role involves driving software lifecycle engineering activities for pathology staining instruments used in cancer diagnostics

Job Summary

  • This role involves driving software lifecycle engineering activities for pathology staining instruments used in cancer diagnostics.
  • The specialist is responsible for ensuring compliance with regulatory requirements and contributing to the product Design History File (DHF).
  • Agilent offers a dynamic international working environment with career development opportunities, pension schemes, and private health care.

Matching Summary

This role involves driving software lifecycle engineering activities for pathology staining instruments used in cancer diagnostics.

Skills & Requirements

Must-have

  • Experience with design control activities
  • Knowledge of medical device regulatory requirements
  • Ability to convert user needs to product requirements
  • Conduct software and cybersecurity risk assessment
  • Collaborate with cross-functional stakeholders

Nice-to-have

  • Knowledge of IEC 62304 and ISO 14971 standards
  • Experience with Agile software development
  • Strong verbal and written English communication skills
  • Systematic approach to complex documentation
  • Ability to manage changing priorities and deadlines

Key Requirements

  • Engineering university degree in IT, Computer, Software, or Life Science
  • Background in software product development and sustaining
  • Experience in regulated environments such as Medical Devices or Pharma
  • Proficiency in requirements engineering and change control

Work Rights

Not specified

Tailored Resume

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