PpFor our client, a leading company in the Pharmaceutical sector we are looking for a Hardware/Software Engineer /p h3Background: /h3 pThe Sub-Chapter Instrument Design Verification is part of RD Near Patient Care, which is accountable for research and development activities on all systems of the Near Patient Care portfolio of our client. /p pWe 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. /p h3The Perfect Candidate: /h3 pThe 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. /p h3General Information: /h3 ul liPlanned Duration of Employment: 12 months /li liExtension (for temporary contracts): possible /li liHome Office: onsite presence preferred, home office to be discussed /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 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 specification /li liCollaboration within the interdisciplinary development team /li liStatus reporting to respective project or product leader /li /ul h3Must Haves: /h3 ul li5+ years of experience working across full product development lifecycles with focus on /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 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 /ul /p #J-18808-Ljbffr