Product Development 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 in accordance with Agilent's Quality Management System (QMS)
  • Ensure Agilent's pathology software products meet regulatory requirements
  • Contribute to the development of product Design History Files (DHF) and documentation
  • Analyze and convert user needs into product requirements and user stories
  • Conduct software risk assessments for safety and effectiveness
  • Collaborate with Test & Validation team for design verification and validation execution
  • Work with cross-functional teams, 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 Agile software development is an asset
  • Full proficiency in English. Proficiency in Danish is a plus but not required

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 organization, offering a dynamic working environment, with exciting challenges and opportunities

Agilent is an Equal Opportunity Employer

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