Systems Requirements Engineer
vor 2 Wochen
Your mission
We 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 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
Your profile
- 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
Why us?
- 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
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