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.

• 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.

• 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.

Reference . 924973

Rolle: Requirement engineer Hardware / Software

Industrie: Pharma

Location: Rotkreuz

Pensum: 100%

Start: ASAP (31.08.2026)

Duration: 12+ months

Deadline: 03/06/2026