Software Design Control Specialist

3 weeks ago


Glostrup, Glostrup Kommune, Denmark Agilent Full time

About the Role

We are seeking a highly skilled Software Design Control Specialist to join our software team in Glostrup, Denmark. As a key member of our team, you will be responsible for executing software design control and test activities, ensuring compliance with regulatory requirements, and contributing to the development of our pathology software products.

Key Responsibilities

  • Execute software design control and test activities adhering to Agilent's Quality Management System (QMS)
  • Ensure Agilent's pathology software products are in compliance with regulatory requirements
  • Contribute to the product Design History File (DHF) and documentation according to internal and regulatory requirements
  • Analyze and convert user needs to product requirements and user stories
  • Act as Test Responsible for design verification execution, including establishment of an automated test suite

Requirements

  • Engineering university degree in IT/Computer/Software, with a background in software product development
  • Experience within design control disciplines and/or automated testing
  • Desire to work with documentation for requirements engineering, design verification, change control, risk management, and defect management
  • Knowledge of regulated environments such as medical devices, pharma, or similar would be a strong advantage
  • Knowledge of medical standards IEC62304 is a plus
  • Knowledge of/experience with Agile software development would be an asset

What We Offer

  • Outstanding company culture
  • Career development opportunities
  • Company pension scheme, individual bonus plan, private health care, medical & life insurance...

About Agilent

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek, so they can do what they do best: improve the world around us.



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