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).
• Within a team of experts, you drive continuous development for high-quality angiographic solutions
• 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).
• Based on your area of involvement, you are in full responsibility for assessment of functional risk, risk-oriented evaluation, and risk-mitigating measures, considering state-of-the-art methods on System / Sub-System Risk Engineering.
• 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. 8-10 years. Master’s degree a plus.
• 8-10 years of experience in MedTech industry.
• You have gained working experience in agile development (e.g. SAFe, SCRUM).
• You have gained working experience with Medical Device Regulation (MDR), 21 CFR PART 820.
• You have worked as a Risk Engineer and have a solid understanding of Product Risk Management process for medical devices (ISO 14971).
• You have 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.
• You are highly motivated to drive change that supports ongoing optimization