Medical Tester

hace 3 semanas

Mexico City ITJ A tiempo completo

Job Summary The Senior Systems Verification Engineer will work with the Development team in the system integration and testing of our In Vitro Diagnostic (IVD) products. The Senior Systems Verification Engineer may provide mentorship to other Verification Engineers, and typically works closely with other team members in the system integration and testing of our medical devices. Key Accountabilities • Assist with the development of project requirements, support tracing of design inputs to design outputs. • Participate in design reviews, develop test automation solutions, and create test plans, test cases, reports, and other deliverables with possible interaction with clinicians, third-party vendors, manufacturers, and others. • Develops verification planning documentation for development projects as needed. • Analyzes requirements and design specifications from a systems perspective. • Develops strategies for system-level product testing, including software, electrical, analytic, and/or mechanical aspects of the system. • Develops system and subsystem test procedures based on product and/or subsystem requirements. • Develops test automation and/or test bench component solutions in support of functional and reliability testing with detailed documentation. • Participates in hazard and risk analysis. • Supports design activities and attends design reviews. • Creates verification reports and overall verification summary reports for systems verification activities. • Creates work breakdown schedule estimates. • Creates and executes test plans and procedures. • Assists with system integration and debugging as needed. • Operates electrical, mechanical, dand igital equipment and test fixtures. • Works well in a team. • May participate in interviews for new department personnel as necessary. • May work on process improvement activities. • Other duties as assigned with or without accommodation. Networking/Key relationships • Research and Development • Quality Engineering • Product Management Minimum Knowledge & Experience required for the position: • BS/BA degree in CS, EE, ME, Biomedical or related Engineering discipline required. • Minimum of seven (7) years of previous experience required; medical device industry experience preferred. • Experience in the full development lifecycle for product delivery to market of at least one product required. Skills & Capabilities: • Test automation experience desired. (Python & Squish) • Testing experience in medical device development or other Regulated industry is desired. • Experience in elicitation, writing and traceability of system/subsystem requirements for product development is desired. • Experience designing and/or creating and utilizing test bench components for system/components testing is desired. • Broad technical understanding of multiple disciplines from electrical, mechanical, software, is desired. • Must demonstrate good document practices (GDP). • Familiarity with reliability testing is desired. • Good communication and presentation skills. • Strong planning and organizational skills required.

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