Systems Requirements Engineer (m/f/d)

Your missionWe are looking for an experienced Systems Requirements Engineer (m/f/d) to join our R&D team.In this pivotal role, you act as the bridge between stakeholders and the development team—translating complex needs into clear, actionable and traceable requirements. Your work plays a critical role in ensuring that regulatory, technical, and business perspectives are cohesively embedded into the design and development of our Clinical Polarizer (Lean Pharma Plant/Device). Your Responsibilities:Capture and analyze stakeholder requirements from Pharma/Concept Exploration and Business Management, translating them into SMART system requirements for the Clinical PolarizerDerive and interpret regulatory requirements based on applicable guidelines and directivesCreate and maintain a complete requirements structure across all levels of the device, ensuring quality, consistency, and full traceabilityWork closely with the Test & Verification team to define the optimal specification depth and ensure value-driven detailSupport the identification and implementation of relevant technical standardsAssist in developing design control processes and help manage key R&D toolsContribute your engineering expertise to support the ongoing development of both Clinical and Pre-Clinical Polarizers Your profileDegree in engineering, medical technology, computer science, natural sciences, or a related fieldSeveral years of hands-on experience as a design engineer in machinery, electrical, electronic, (software), or fluid-dynamics disciplines within a regulated product development environment—ideally in pharmacology, medical technology, cosmetics, or laboratory equipment4+ years of proven experience in requirements engineering, including development, maintenance, and documentation of the requirements file (RE-File)IREB Level 3 CPRE certification, ideally with a focus on Requirements Elicitation, is a plusProficient in using design control and requirements management toolsStructured and pragmatic mindset, with strong analytical and results-driven working styleStrong team player with clear and confident communication skills in English, both written and spoken Why us?Competitive compensation, including base salary and virtual sharesOnsite work (Ulm) in a modern office/lab environment with home-office opportunities (no relocation necessary)Attractive relocation package (if necessary)Annual health budget (Allianz bKV)30 vacation daysFlexible working hoursKey role in a highly advanced and fast-growing startup companyAmple opportunity for personal initiatives, openness to new ideas, and room for considerable personal impactImpactful product promoting better understanding and treatment of diseaseInternational and dynamic team, comprising over 20 different nationalitiesEGYM Wellpass membershipPermanent employment contract, providing stability and long-term career growth opportunitiesEnjoyable work atmosphere with an open-door and open communication mentality By submitting your application, you acknowledge and agree to our data protection and privacy policy.