Manufacturing Engineer

 Job Description & Skill Requirement:

•    Responsibilities: Develop and Execute remediation plan for Affera OQW PLX findings
a.    Support action plans to develop and implement process controls
b.    Update documentation in PLM systems
c.    Support labeling system improvement project
•    Skills required
a.    Manufacturing Engineering, line layouts, process development, process validation
b.    Experience with CAPA, root cause analysis, gemba waks
c.    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.
• 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