We are seeking an experienced Principal Engineer to provide technical and organizational leadership for Process & Product Technical Services within the Medical Devices business unit. This role is responsible for leading strategic engineering projects, supporting manufacturing operations, driving process and product improvements, and developing engineering talent. The position oversees a team consisting of a Senior Engineer and an Engineer II while collaborating across multiple functions to ensure regulatory compliance, operational excellence, and successful delivery of business objectives.

Requirements

BS in Engineering or Science Field and 3-5 years related experience in manufacturing or project engineer in a closely related industry or
MS in Engineering and 1-2 years related experience in manufacturing or project engineer in a closely related industry.
Bilingual (Spanish and English) written and verbal.

所需技能

Process improvement (manufacturing)Validation planning and execution (IQ/OQ/PQ, SAT, FAT, OP)Regulatory compliance and FDA interactionsChange control managementProject coordination and cross-functional collaborationStatistical and analytical data analysisSix Sigma methodology and toolsEquipment and product transfer/scale-up coordinationTechnical troubleshooting and root-cause analysisSupplier and external consultant managementResource planning and workload prioritizationEHS promotion and compliance (safety management)Technical documentation and URS/SOP writingBilingual communication (Spanish and English)

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