Requirement engineer hw/sw

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.

General Information

• Start Date: asap
• Latest Possible Start Date: 31.08.2026
• Planned Duration of Employment: 12 months
• Extension (for temporary contracts): possible
• Workplace: Rotkreuz
• Workload: 100%
• Home Office: onsite presence preferred.

Tasks & Responsibilities

• Definition of technical requirements for diagnostic instruments based on business and customer inputs, risk ratings and context according to internal 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