• Collaborate with Quality Engineering to provide manufacturing support.
• Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
• Should be experienced in conducting Time Study for various assembly line
• Should be experienced in Medical device manufacturing assembly lines
• Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
• Need to conduct qualification, verification, and validation activities to produce medical devices.
• Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.
• Need to design, procure, and fabricate tooling and fixtures.
• Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices.
• Train, develop, and/or provide work direction to operators and technicians.
• Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
• Participate in design control efforts related to risk analysis (failure mode and effect analysis) & design reviews.
• Work with CFT teams in troubleshooting problems on the production floor.
• Need to identify and implement process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance.
• Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements.
Qualification:
• BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering
• Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.
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