<div class="show-more-less-html__markup show-more-less-html__markup--clamp-after-5 relative overflow-hidden"> <p>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.</p><p><br/></p><p>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.</p><p><br/></p><p><br/></p><p><strong>General Information:</strong></p><p><br/></p><ul><li>Start Date: to be discussed</li><li>Planned Duration: unlimited via Hays</li><li>Workplace: Rotkreuz</li><li>Travel: 20% - 30%</li></ul><p><br/></p><p><br/></p><p><strong>Tasks &amp; Responsibilities: </strong></p><p><br/></p><ul><li>Definition of technical requirements for diagnostic instruments based on business and customer inputs, risk ratings and context according to internal guidelines</li><li>Knowledge in definition of requirements using EARS (Easy Approach to Requirements Syntax)</li><li>Contribution to the development of requirement engineering concepts and strategies for software and hardware on different levels</li><li>Review of requirements and specifications</li><li>Collaboration within the interdisciplinary development team</li><li>Status reporting to respective project or product leader</li></ul><p><br/></p><p><br/></p><p><strong>Must Haves:</strong></p><p><br/></p><ul><li>5+ years of experience working across full product development lifecycles with focus on requirements engineering</li><li>Background in regulated environments, ideally within IVD or medical device development</li><li>Strong requirements engineering experience, including ALM tools and requirement breakdown/structuring</li><li>Certifications such as CPRE/IREB, CCBA/IIBA, or INCOSE are advantageous</li><li>Experience with requirement analysis, test case creation, test execution, and defect lifecycle management</li><li>Understanding of the V-model</li><li>Strong analytical thinking, problem-solving, and ability to balance big-picture and detail-oriented work</li><li>Experience moderating and collaborating with multidisciplinary stakeholders and teams</li><li>Strong communication skills, autonomous working style, and pragmatic mindset</li><li>Fluent English and German are required</li></ul><p></p> </div>