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Katalyst Healthcares & Life Sciences

MANUFACTURING ENGINEER Job at Katalyst Healthcares & Life Sciences in North

Katalyst Healthcares & Life Sciences, North Haven, CT, United States

Responsibilities:

  • 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 processes; analyses and interpret process models and recommend process improvements 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 activitie.

  • 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.


Requirements:


  • 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.