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Katalyst CRO

Sr Manufacturing Engineer

Katalyst CRO, Irvine, California, United States, 92713

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Sr Manufacturing Engineer

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Sr Manufacturing Engineer

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Katalyst CRO Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensure processes and procedures are following regulations.

Responsibilities

Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensure processes and procedures are following regulations.

Requirements:

BS Engineering and 4+ years in Medical Device Manufacturing. Process Validation. Supporting manufacturing and investigating non-conformances. Understanding of various manufacturing processes: This includes knowledge of materials, manufacturing techniques (e.g., injection molding, machining, assembly), and quality control methods. Ability to identify and resolve manufacturing issues: This involves analyzing data, identifying root causes, and implementing effective solutions. Familiarity with statistical process control (SPC) and Six Sigma methodologies. Seniority level

Seniority level Associate Employment type

Employment type Contract Job function

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