Requirements Engineer (m/f/d)
Requirements Engineer (m/f/d)
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Job Description
Your mission
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 teamtranslating 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 environmentideally 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
contact information
Sandra Schrli
Senior Talent Acquisition Manager
mail:
Please note that for data privacy reasons well not review applications or CVs sent via email. Unsolicited applications can be submittedhere.
About us
NVision 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.
Employment Type
Full-Time
