System Engineer Sr

Descripción del Empleo:
Performs technical planning, system integration, verification and validation, cost and risk, and supportability and effectiveness analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of customer or product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

Position Responsibilities • Responsible for providing MES support, user training, updating procedures, identifying issues and priorities, representing issues to the Global team, and tracking non–system
Requisitos:
Skills • Analytical Thinking • Problem Solving • Interpersonal Relations
• Quality and Results Oriented
• Computer Literate
• Fluency speaking and writing in English and Spanish

Background
• Experience in medical device, pharmaceutical, or electronic industry
• Proficient knowledge of computer system of cycle concepts, change control systems and FDA regulatory requirements, including 21 CFR Part 11 and Systems Validation
• Experience in implementing Mfg Execution Systems (MES), preferred.
• Experience in the development and implementation of IQ, OQ and PQ