Job Description Translating business and user requirements to product requirements Knowledge of Systems Engineering Lifecycle with in-depth knowledge of requirements analysis; design of systems architectures and high-level designs; delivering technical presentations to various management levels. Responsible for development of technical requirements and product verification strategy Derives requirements from high-level marketing requirements into product-level functional requirements. Leads and participates in design reviews, including reviews of design inputs and outputs Reviewing verification results to confirm product requirements are met Identifying and mitigating areas of technical risk by following the product design FMEA process Executes Safety Risk Management, design analysis, test planning, test procedure development, verification & validation, and certification Should be able to prepare/ evaluate the traceability matrix, identify gaps and remediate Works hand in hand with the program manager, product manager, and cross-functional leads to ensure the overall product/solution system integrity from concept to end-of-life of the product, including meeting all expectations from major stakeholders like manufacturing, quality, regulatory bodies, and reliability in addition to customers and patients Coordinates with User Interface, Engineering, Marketing, Procurement, Operations, and V&V teams Perform root cause investigation, corrective action determination and deployment, containment activities, and all other activities related to the Corrective Action/Preventive Action (CAPA) process
System Engineer with Requirements gathering and &V knowledge