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

m/f/d, Zug

Job profile (B96R1P)

Life Sciences - IT + Digital
Zug
Contracting
Full Time
asap - 31.08.2026
EARS, ALM

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.

Start date: asap
Latest Start date: 31.08.2026
Planed Durration: 12 Months (extension possible)
Workload: 100%
Contract Type: Contracting
Location: Rotkreuz
Remote: onsite presence preferred, home office to be discussed
Travel: 20% - 30%
Team size: ca. 8 (Project size: appr. 80)

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