Validation Engineer

Essential Duties: Generate and conduct validation plan for assigned projects to include defining the objective, scope, time frame, budget, and procedures to accomplish the task. Evaluate feasibility of concepts to meet functional, clinical, and customer needs and provide input on the design, manufacturing process, quality needs, and testing during the development process. Design, optimize, and update processes and products utilizing lean concepts. Assist with defining, drafting, and performing product verification and validation activities (V&V). Coordinate and support stability study sample generation, pulls, and testing with internal and external personnel/vendors. Generate protocols, analyze data, and generate reports related to testing results. Collaborate in inter-departmental activities to ensure timely completion of project tasks.
Requisitos:
Bachelor's degree in engineering. Mechanical or Electrical is desired but other disciplines will be considered. Commensurate experience without Engineering degree may be considered for exceptionally qualified candidates. One to three years of applicable work experience in an Engineering and/or Manufacturing environment is desired. Good oral and written communication skills (English and Spanish). Computer Literate (Microsoft Office, Project Management, Statistics) Knowledge in Six Sigma and Lean Manufacturing concepts.
Experience in the management of medium projects involving multi-disciplinary components as well as process/product Validations. Frequent use and application of technical standards, principles, theories, concepts and techniques. Primarily internal company contacts. Infrequent inter-organizational and outside customer contacts on routine matters.