Requirement engineer Hardware​/Software; m​/f​/d

Overview

For our client, a leading company in the pharmaceutical manufacturing industry, we are seeking a candidate who brings over 5 years of experience driving the full product development lifecycle, with a sharp focus on requirements engineering within highly regulated environments, ideally in In Vitro Diagnostics (IVD) or medical device development. They possess a deep understanding of the V-model and extensive hands‑on expertise in requirement analysis, structuring, and breakdown using advanced ALM tools.

• Start Date:
  
  asap
• Latest Possible
  
  Start Date:
  
  31.08.26
• Planned Duration of Employment: 12 months
• Extension (for temporary contracts): possible
• Home Office: onsite presence preferred, home office to be discussed
• Travel: 20% - 30%
• Team size: ca. 8 (Project size: appr. 80)
• Working Hours:
  
  Standard
• Criminal record extract required: no

• Definition of technical requirements for diagnostic instruments based on business and customer inputs, risk ratings and context according to internal Roche guidelines
• Knowledge in definition of requirements using EARS (Easy Approach to Requirements Syntax)
• Contribution to the development of requirement engineering concepts and strategies for software and hardware on different levels
• Review of requirements and specifications
• Collaboration within the interdisciplinary development team
• Status reporting to the respective project or product leader

• 5+ years of experience working across full product development life cycles with a focus on requirements engineering
• Background in regulated environments, ideally within IVD or medical device development
• Strong requirements engineering experience, including ALM tools and requirement breakdown/structuring
• Certifications such as CPRE/IREB, CCBA/IIBA, or INCOSE are advantageous
• Experience with requirement analysis, test case creation, test execution, and defect lifecycle management

Please apply online.