Sr. Manufacturing Engineer - Katalyst Healthcares & Life Sciences

Bedford, MA 01730

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.

Source : Katalyst Healthcares & Life Sciences