Job description
Do you want to help create the future of healthcare? Our name, Siemens Healthineers , was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone to grow personally and professionally. Sound interesting? Then come and join our team as Lead System Engineer Role at Advanced Therapi es and help shape the future of Siemens Healthineers with your passion for medical technology and your enthusiasm for innovation. Your tasks and responsibilities: You will drive continuous evolution and development for high-quality system functional specifications through your advanced knowledge of Requirement Engineering. 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 ensure continuous system-oriented development, ensure reliable clarification on system-relevant aspects and supports release activities as a system expert. 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. You will support feature development from inception through all testing phases (system integration, verification, & validation). 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, Test Engineer, and other Requirement Engineers. During Program Increments, you will ensure that Continuous Solution-oriented technical clarification (e.g., definition of NFRs) is happening. Plan and coordinate system integration with Project Management and Technology. Evaluate test results and provide recommendations for project decisions. Lead the Change Control Board (CCB) and coordinate change requests and defect reports. Support patent applications by evaluating content for feasibility and business impact. Your qualifications and experience: Bachelor’s degree in biomedical Electronics/Engineering, Electrical Engineering, Systems Engineering, or related field required. 12-14 years. Master’s degree a plus. You have many years of professional experience in MedTech industry. You have experience working with Agile Release Train (ART) based SW development setup and supporting 3-4 scrum teams with your Systems Engineering and Risk Engineering expertise. You have gained work experience with Medical Device Regulation (MDR), 21 CFR PART 820, ISO 13485. You have working understanding of IEC, EN and ISO standards for medical Devices. You have working understanding of SDLC process and IEE 29148 - International Standard - Systems and software engineering -- Life cycle processes -- Requirement's engineering. Your attributes and skills: Your strong analytical and purposeful mindset, as well as your ability to drive reliable decision-making, sets you apart from the rest. You have outstanding communication, facilitation, and coordination skills; working with international, intercultural, and interdisciplinary teams easily comes to you. "Today is about tomorrow": you are initiative-taking to drive change that supports ongoing optimization.
This job post has been translated by AI and may contain minor differences or errors.
