Job Description

Cyient is a global engineering and technology solutions company.As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems. With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization\'s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy. A Hardware embedded engineer we can write SRD\'s Test Requirements Algorithm\'s (Manuals & Build scenario\'s etc) Requirements flowdown from the stake holder needs, medical standards like IEC60601 Work with customer-facing team members (human factors and voice-of-customer specialists) to understand user needs and convert them into high-level product specifications. Develop detailed technical requirements, and ensure accurate flow-down to sub-system requirements, design implementation. Discuss with system verification engineers to ensure that the system requirements are adequate and verfiable Define the use condition and use cases to develop the system features. Define the logics and provide inputs to the software team for implementing the use cases. Perform risk assessment for the product and develop risk mitigation strategies. Identify applicable regulatory and industry standards and ensure product can satisfy requirements of these standards. Update of the requirements based on the risk control measures recommended in the risk management file Work with operations and supply chain to ensure manufacturability of the product and identify contract manufacturers who can build the product. Participate in design transfer activities. Work with quality/reliability engineering to identify and minimize sources of technical and practical risk, and ensure the product meets medical device-related safety standards. Work with clinical and regulatory groups to ensure the product is approved for commercial use Review the design inputs and outputs to ensure quality Must Have 6-8 years of experience in medical or aerospace domain with B.E. or B.Tech. in Mechanical/Electrical Engineering from a reputed university. Experience with electromechanical design and optimization of fluid circuits including fluid mechanics, pumps, valves, heaters, sensors, fluidic connectors and tubing, together with a working knowledge of the supply base for fluidic components. Handson experience in Requirements management and risk management Understanding of electronics concepts (microcontrollers, power supplies, programmable logic) Experience in requirement management, risk management(FMEA, PHA) Knowledge of medical device quality and regulatory standards (ISO 13485, ISO 14791, IEC 60601, IEC 62304, etc.) Ability to independatly lead project / coach team memebers Good verbal/written communication skills. Ability to produce good quality documentation. Ability to work in a global environment and interact with various internal and external stake holders. Expertise with Microsoft Project, Excel, Word and PowerPoint Desired / Preffered Qualifications 6+ years\' experience in the healthcare domain, with knowledge of medical device-related standards such as ISO 13485, US FDA\'s 21 CFR 820, IEC 60601, IEC 60068 and ISO 10993 Understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies) Working knowledge of dialysis therapy Basic understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies) Basic understanding of chemistry concepts (working knowledge of water purification technologies, including filtration, reverse osmosis, carbon beds, and ion exchange processes) Experience in MBSE Skills & Experience Microcontrollers, Power Supplies, Sensors Design Cyient is an Equal Opportunity Employer. Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.

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