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Engineer II
The Validation/Project Engineer is responsible for supporting New Product Introduction (NPI) and New Product Development (NPD) projects related to extruded medical device components. This role ensures successful transfer from concept to commercial production by coordinating cross-functional teams, driving process development, and ensuring compliance with regulatory and quality standards.
The position requires strong structured project execution, technical and hands-on problem-solving skills and the ability to communicate effectively across engineering, operations, quality, and external stakeholders. Experience or exposure to polymer extrusion is a plus.
Requisitos: Requirements: Bachelor's Degree Engineering (Mechanical, Chemical, Polymer, Materials, or related field required) 3–5 years of engineering experience (minimum) in a regulated industry 2+ years of direct experience in extrusion process development or manufacturing preferred Experience in medical device NPI/NPD preferred Proven track record of executing process validation (IQ/OQ/PQ) Experience working in cross-functional, global teams Requiere Mucha Experiencia Requires Expert
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