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Requirement engineer Hardware/Software (m/f/d) Zug

HHJ BAU GmbH · Zug

Senior freelance requirement engineer for hardware/software in Zug, focusing on diagnostic instruments within Roche's Near Patient Care R&D. On-site role in a regulated medical device environment.

This position is responsible for defining and structuring technical requirements for diagnostic instruments within Roche's Near Patient Care R&D. The role supports verification activities and provides status updates to project and product leadership, operating within a highly regulated medical device environment.

Responsibilities

  • Define technical requirements for diagnostic instruments based on business needs, customer input, and risk assessments
  • Apply and structure requirements using EARS (Easy Approach to Requirements Syntax) and internal standards
  • Develop and refine requirements engineering concepts and strategies across software and hardware domains
  • Review and validate requirements and system specifications to ensure completeness and compliance
  • Collaborate closely with interdisciplinary teams (software, hardware, systems, testing)
  • Support verification activities, including test case creation, execution, and defect lifecycle management
  • Provide status updates and reporting to project and product leadership

Requirements

  • Experience in requirements engineering across the full product development lifecycle
  • Strong background in regulated environments (IVD or medical devices preferred)
  • Deep understanding of the V-model and system development processes
  • Expertise in requirements structuring, analysis, and ALM tools
  • Strong analytical mindset with the ability to balance big-picture thinking and attention to detail
  • Effective communicator and facilitator across multidisciplinary teams and stakeholders
  • Autonomous, pragmatic working style with strong problem-solving capabilities and fluent English & German

What the company offers

  • Opportunity to work on cutting-edge diagnostic instruments within Roche’s Near Patient Care R&D
  • Exposure to end-to-end product development in a highly regulated medical device environment
  • Collaborative, international project setting with high technical impact and innovation focus

About the company

Hays is the biggest privately owned IT recruitment agency in Germany. Hays offers services that are free of charge, non-binding and discreet.

  • Hays is the biggest privately owned IT recruitment agency in Germany.
  • Hays offers services that are free of charge, non-binding and discreet.

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