Requirements Engineer

Your missionWe are looking for an experienced 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 PolarizersYour 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 spokenWhy 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 hours Key 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 mentalitycontact informationAny questions? Please contact:Sandra Schärli Senior Talent Acquisition Managermail: careers@nvision-imaging.comPlease note that, for data privacy reasons, we'll not review applications or CVs sent via email. Unsolicited applications can be submitted here. About usNVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are just leaving stealth mode, moving from local R&D to global commercialization and expansion.We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body, with tremendous potential for research and applications in oncology, cardiology, neurology and more. Our company brings together expertise in physics, chemistry, engineering and medicine, and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York, MD Anderson in Texas, Technical University of Munich, Cambridge University in the UK and more.NVision is developing fast, robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast, fully-automated, multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in-house.  We offer a dynamic international working environment, with immense room for growth, that encourages personal initiative and open communication.