Ph3Overview /h3 pFor our client, a leading company in the pharmaceutical manufacturing industry, we are seeking a candidate who 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. /p h3General Information /h3 ul liStart Date: asap /li liLatest Possible Start Date: /li liPlanned Duration of Employment: 12 months /li liExtension (for temporary contracts): possible /li liHome Office: onsite presence preferred, home office to be discussed /li liTravel: 20% - 30% /li liTeam size: ca. 8 (Project size: appr. 80) /li liWorking Hours: Standard /li liCriminal record extract required: no /li /ul h3Tasks Responsibilities /h3 ul liDefinition of technical requirements for diagnostic instruments based on business and customer inputs, risk ratings and context according to internal Roche guidelines /li liKnowledge in definition of requirements using EARS (Easy Approach to Requirements Syntax) /li liContribution to the development of requirement engineering concepts and strategies for software and hardware on different levels /li liReview of requirements and specifications /li liCollaboration within the interdisciplinary development team /li liStatus reporting to the respective project or product leader /li /ul h3Must Haves /h3 ul li5+ years of experience working across full product development lifecycles with a focus on requirements engineering /li liBackground in regulated environments, ideally within IVD or medical device development /li liStrong requirements engineering experience, including ALM tools and requirement breakdown/structuring /li liCertifications such as CPRE/IREB, CCBA/IIBA, or INCOSE are advantageous /li liExperience with requirement analysis, test case creation, test execution, and defect lifecycle management /li /ul liUnderstanding of the V-model /li liStrong analytical thinking, problem-solving, and ability to balance big-picture and detail-oriented work /li liExperience moderating and collaborating with multidisciplinary stakeholders and teams /li liStrong communication skills, autonomous working style, and pragmatic mindset /li liFluent English and German are required /li pPlease apply online. /p /p #J-18808-Ljbffr