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

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

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 life cycles, 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 life cycles 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

• Contracting
• asap - 31.08.2026