Your tasks and responsibilities:
• Provide cross-team System Engineering and Requirement Engineering expertise and product lifecycle support to all other disciplines (Product Mgt, Hardware, Software, Test).
• While working at Agile Release Train (ART) Level of SAFe, you will be supporting 1-2 scrum teams with your System Engineering expertise.
• You will support feature development from inception through all testing phases (system integration, verification, & validation).
• You are responsible for reviewing user needs documentation (SRS), development/preparation of appropriate system functional specification (having Design Inputs) and support activities on continuous system integration.
• Within a team of experts at ART level and Solution, you will drive continuous evolution and development for high-quality system functional specifications
• You are an essential part of a cross-functional Team and therefore your responsibility involves close collaboration with multiple stakeholders, e.g. Product Manager, Product Owner, Risk Engineer, Scrum Master other Requirement Engineers.
• During Program Increments, you will ensure that Continuous Solution-oriented technical clarification (e.g. definition of NFRs) is happening
Your qualifications and experience:
• Bachelor’s Degree in Biomedical Electronics/Engineering, Electrical Engineering, Systems Engineering, or related field required. 5-8 years. Master’s degree a plus.
• You have many years of professional experience in product development of medical systems
• You have gained working experience in agile development (e.g. SAFe, SCRUM).
• You have gained working working experience with Medical Device Regulation (MDR), 21 CFR PART 820 and MDD
• You have in good knowledge and understanding of IEC, EN and ISO standards for medical Devices
• You have an good level understanding of SDLC process and IEE 29148 - International Standard - Systems and software engineering -- Life cycle processes -- Requirement's engineering
Your attributes and skills:
• Your excellent fluency in English enables you to collaborate with your international colleagues
• Your strong analytical and results-oriented mindset, as well as your ability to drive reliable decision-making, set you apart from the rest
• You have outstanding communication, facilitation and coordination skills; working with intercultural and interdisciplinary teams comes easily to you.
• "Today is about tomorrow": you are highly motivated to drive change that supports ongoing optimization