We need a Manufacturing engineer with an Automation Equipment validation exp.
Minimum 7 years of experience
Experience working with equipment suppliers
Experience in supporting machine builders with kick off and design
Experience with Semi-automated and automated equipment
Experience with process development in various different processing including but not limited to
Joining technologies / Dispensing / Cannula tipping / Pad printing
Experience working on print review and working with design on print updates
Experience working in QMS and ERP systems
Experience with IQ/OQ/PQ/TMV preferred
Worked with cross functional teams
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 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 contributing 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.
Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
Work with CFT teams in troubleshooting problems on the production floor.