Requirement engineer Hardware​/Software

A leading medical device company is looking for a Requirement engineer Hardware / Software based in Zug, Switzerland.

• 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 develop men
• 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