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.
General Information
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
Tasks & Responsibilities
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
Must Haves
5+ years of experience working across full product development lifecycles 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
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
Please apply online.
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