Manufacturing Engineer

Description:

Skills:

• Medical Device
• Process Validation
• Team Leadership
• SPC (Statistical Process Control)
• ISO 13485
• IQ, OQ, PQ, DOE
• Regulatory Compliance
• pFMEA
• SOP
• URS
• QMS
• Clean Rooms
• CTQ
• FDA
• GMP
• Processes Engineering Changes (ECR, ECO, ECN)
• Problem Solving
• Agile
• Minitab
• 21 CFR 820
• Project Management
• Project Planning

Job Description:

• 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

o 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 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.

• 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.