System Engineer

4 weeks ago

Trivandrum, India Terumo Blood and Cell Technologies Full time

JOB SUMMARYSenior systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components. Senior systems engineer will practice design controls in compliance with the quality management systems to deliver on products that are effective, safe and compliant. In this role you are expected to coordinate the design activities in collaboration with various stakeholders including mechanical, electrical, software, quality, manufacturing and commercial Teams. As a senior systems engineer you are expected to independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.ESSENTIAL DUTIES- Translate user and business requirements into detailed product requirement specifications and design specifications.- Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development.- Lead multidisciplinary design efforts to ensure seamless integration and timely delivery.- Collaborate globally to integrate mechanical, electrical, and software components, achieving functional and reliability goals.- Lead design changes to implement and enhance features for blood collection platforms, ensuring quality and regulatory compliance.- Independently conduct technical reviews with stakeholders to meet project design objectives.- Perform failure analyses to prioritize testing and ensure design completeness and product quality- Communicate and collaborate effectively to align teams and streamline workflows.- Support design

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