Requirements Engineer (m/f/d)

About the Company

At Jaeger Medical, we are redefining the diagnosis of respiratory diseases. Our solutions set new standards in accuracy and ease of use, with the goal of making a meaningful difference for healthcare professionals and patients worldwide. Join a team that is shaping the future of respiratory diagnostics with cutting-edge technology and a passion for excellence. We are a team of over 400 dedicated employees worldwide. For over 70 years, Jaeger Medical has been developing, manufacturing, distributing, and supporting state-of-the-art technologies in the fields of pulmonary function testing, cardiopulmonary exercise testing, and spirometry. Our established brands—Vyntus, SentrySuite, and MicroGard—are at the heart of our innovations in diagnostic devices, software, and consumables. Our customer-centric corporate culture is shaped by our daily interactions with healthcare providers and their patients around the world. We value our diversity, openness, and collaboration. We are committed to treating the communities and the environment we enjoy with respect, and we place sustainability at the heart of our future developments. Together with our passionate and talented employees, we are committed to sustainable growth to ensure that Jaeger Medical remains a leading and successful healthcare company for the next 70 years and beyond.

About the Role

As Requirements Engineer (m/f/d) you will be responsible for eliciting, analyzing, documenting, validating, and managing product requirements throughout the development lifecycle, ensuring compliance with industry regulations and standards.

Responsibilities

Requirements Elicitation & Analysis

Elicited and analyzed requirements from clinical, regulatory, marketing, software, and hardware stakeholders, translated into consistent system and user requirements

Requirements Documentation

Clear, testable requirements specifications authored and maintained in Helix ALM, compliant with medical device design-control expectations

Traceability & Change Management

End-to-end bidirectional traceability established and maintained across requirements, risk management, design outputs, and verification/validation artifacts

Verification & Validation Support

Requirements-driven verification & validation support, ensuring complete test coverage and alignment of test protocols and reports with approved requirements

Standards & Regulatory Compliance

Regulatory-compliant requirements lifecycle, aligned with FDA 21 CFR Part 820, IEC 62366, and applicable medical device standards

Collaboration

Cross-functional coordination with Project Management, supporting planning, change control, and on-time delivery across all development phases

Qualifications

• Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Software Engineering, or a related field
• 2. 5+ years of experience in requirements engineering, systems engineering, or business analysis in a regulated environment (preferably medical devices)
• Familiarity with medical device development and regulatory environments (e.g., ISO 13485, FDA, MDR)
• Solid understanding of product development life cycles (Waterfall and Agile) and risk management principles
• Oral and written communication skills in German and English language
• Experience with requirements management tools (preferably helix)
• Knowledge of usability engineering (IEC 62366) or software lifecycle standards (IEC 62304) is a plus

What we offer

• Flexible working hours with the option to work partially from home for a good work-life balance
• A modern work environment in a pleasant atmosphere with a highly motivated team
• Opportunity to contribute to innovative projects in a forward-looking industry
• Opportunities for ongoing training and professional development
• 30 vacation days per year, plus special leave for exceptional life events
• Reimbursement for public transportation costs
• Company pension plan
• A wide variety of employee benefits, such as the Corporate Benefits platform, discounted membership at a local gym, bike leasing, etc.
• Well-developed infrastructure, access to the cafeteria, modern workstations with air conditioning, etc.
• Free beverages

Equal Opportunity Statement

We value our diversity, openness, and collaboration. We are committed to treating the communities and the environment we enjoy with respect, and