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Responsibilities:

• Collaborate with quality engineering to provide manufacturing support
• Be an equipment owner (including custom PLC equipment)
• Provide manufacturing engineering support to specific projects including change analysis, risk analysis and manufacturing readiness
• Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery, of components and finished devices
• Conduct qualification, verification and validation activities to produce medical devices
• Complete 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
• 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) and design reviews
• Interface with product builders or extrusion technicians, production supervisors and engineers in troubleshooting problems on the production floor
• Identify and implement process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance
• Design, develop, test, and validate equipment and processes; analyze and interpret process models and recommend process improvements

Requirements:

• Bachelor's degree in engineering required; concentration in mechanical, industrial or manufacturing engineering preferred
• 4+ years of related work experience required
• Manufacturing engineering in a FDA regulated environment preferred
• Experience with controls, PLCs, and/or SQL -preferred
• Ability to read/understand engineering drawings on common engineering software preferred
• Experience with Minitab or similar statistical software preferred
• AutoCAD experience -preferred
• Experience using or understanding Lean tools/principals -preferred