Requirements Engineer (m/f/d)

We 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 Polarizer
• Derive and interpret regulatory requirements based on applicable guidelines and directives
• Create and maintain a complete requirements structure across all levels of the device, ensuring quality, consistency, and full traceability
• Work closely with the Test & Verification team to define the optimal specification depth and ensure value-driven detail
• Support the identification and implementation of relevant technical standards
• Assist in developing design control processes and help manage key R&D tools
• Contribute your engineering expertise to support the ongoing development of both Clinical and Pre-Clinical Polarizers

• Degree in engineering, medical technology, computer science, natural sciences, or a related field
• Several 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 equipment
• 4+ 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 plus
• Proficient in using design control and requirements management tools
• Structured and pragmatic mindset, with strong analytical and results-driven working style
• Strong team player with clear and confident communication skills in English, both written and spoken

• Competitive compensation, including base salary and virtual shares
• Onsite 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 days
• Flexible working hours 
• Key role in a highly advanced and fast-growing startup company
• Ample opportunity for personal initiatives, openness to new ideas, and room for considerable personal impact
• Impactful product promoting better understanding and treatment of disease
• International and dynamic team, comprising over 20 different nationalities
• EGYM Wellpass membership
• Permanent employment contract, providing stability and long-term career growth opportunities
• Enjoyable work atmosphere with an open-door and open communication mentality