Requirement engineer

Requirement engineer Hardware / Software: Requirements Engineering / ALM / CPRE/IREB, CCBA/IIBA, or INCOSE / System Engineering / Software Engineering / Medical Engineering / IVD / Diagnostic Instruments/ German/ English

Background:
The Sub-Chapter Instrument Design Verification is part of R&D Near Patient Care, which is accountable for research and development activities on all systems of the Near Patient Care portfolio from Roche Diagnostics.

We are looking for someone with a technical background, ideally in system engineering, software engineering or medical engineering who brings experience in software and hardware requirement engineering – and eventually testing – for diagnostic instruments.

The Perfect Candidate:
The perfect candidate 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.

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 respective project or product leader

Must Haves:
* 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

Reference Nr.: 924973
Rolle: Requirement engineer Hardware / Software
Industrie: Pharma
Location: Rotkreuz
Pensum: 100%
Start: ASAP (31.08.2026)
Duration: 12+ months
Deadline: 03/06/2026

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: +41 41 760 77 01.
About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.