R&D Software Design Control Specialist

2 months ago


Glostrup, Glostrup Kommune, Denmark Agilent Full time

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.

Job Summary

We are seeking a highly skilled R&D 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 activities, ensuring compliance with regulatory requirements, and contributing to the development of high-quality software products.

Key Responsibilities

  • Execute software design control 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
  • Conduct software risk assessment for safety and effectiveness of the product
  • Collaborate with Test & Validation responsible for design verification and validation execution
  • Collaborate with a broad range of stakeholders in the organization, including Marketing, Procurement, Regulatory Affairs, Quality Assurance, Manufacturing, Developers, and Global Service, Usability & Solution

Requirements

  • Engineering university degree in IT/Computer/Software, with a background in product development and sustaining/maintenance
  • Experience with design control, including requirements engineering, design verification, change control, product risk management, defect management, and documentation
  • Experience in a regulated environment, such as medical devices, pharma, or similar
  • Knowledge of medical standards IEC62304 is a plus
  • Knowledge of / experience with Agile software development would be an asset
  • Full proficiency in English. Proficiency in Danish would be a plus but is not a requirement

What We Offer

  • Outstanding company culture
  • Career development opportunities
  • Company pension scheme, individual bonus plan, private health care, medical & life insurance...
  • A position within an international organisation, offering a dynamic working environment, with exciting challenges and opportunities

Agilent is an Equal Opportunity Employer



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