For our client, we are looking for an experienced Requirements Engineer who confidently defines and structures technical requirements for diagnostic instruments in a regulated environment, effectively collaborates within interdisciplinary development teams, and brings strong expertise in requirements engineering, ALM tools, and product development lifecycles, in order to ensure compliant, traceable, and high-quality software and hardware requirements throughout the development process.
End date: 31.08.2026
Contract Type: Contracting
Your Tasks:
* 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 respective project or product leader
Your Profile:
* 5+ years of experience working across full product development lifecycles with 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
* Understanding of the V-model
* Strong analytical thinking, problem-solving, and ability to balance big-picture and detail-oriented work
* Experience moderating and collaborating with multidisciplinary stakeholders and teams
* Strong communication skills, autonomous working style, and pragmatic mindset
* Fluent English and German are required
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