Sr. Manufacturing Engineer

4 weeks ago

Bedford, United States Katalyst Healthcares and Life Sciences Full time
Requirement:
  • Responsibilities: Develop and Execute remediation plan for Affera OQW PLX findings
  • Lead and execute action plans to develop and implement process controls
  • Update documentation in PLM systems
  • Support labeling system improvement project.
  • Manufacturing Engineering, line layouts, process development, process validation.
  • Experience with CAPA, root cause analysis, gemba walks, six sigma (preferred).
  • General understanding of Packaging and labeling for medical devices.
  • 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.
Requirements:
  • 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.
  • BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering.

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