Sr Manufacturing Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Irvine, CA 92620
Description:
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.
- 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.