Job Description

Provide technical knowledge in new product launch into manufacturing

Your tasks

• Work collaboratively with engineers and customer personnel to design and develop silicone extrusion and molding processes using existing and innovative technologies.
• Develop process validation protocols and reports, in accordance with applicable corporate procedures and in conjunction with senior engineers and the customer project team.
• Specify new and existing product processes at a high level through the creation of process flowcharts and diagrams.
• Create bills of materials, manufacturing procedures, and routers for components, assemblies, packaging, labeling, and other documents needed for the device master record.
• Specify required machinery, fixtures, gauges, and other equipment needed for the verification and manufacture of medical devices.
• Work with internal resources to obtain and plan for the installation of equipment in a clean environment.  Create and execute Installation Qualification protocols and reports.
• Design or aid in the design/modification of extrusion and molding processing tooling.
• Train technicians and manufacturing associates on manufacturing processes in conjunction with the operations team through product launch and subsequent sustaining engineering actions.
• Develop test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
• Ensure developed processes meet or exceed the required cycle time to meet initial production forecast and cost. Create DOEs to characterize and improve processes.
• Investigate and/or create EO (Engineering Change Orders), disposition material, develop and implement process changes and proper documentation of any such changes.
• Attend daily meetings to provide communication and technical support to meet daily production requirements and NPI project timelines.
• Initiate improvements in new and existing processes to improve part quality/yields, cycle times, and to reduce cost, using LEAN manufacturing and Six Sigma skills.

Job skills

• Bachelor of Science in Mechanical, Manufacturing, Industrial Engineering. EIT or PE a plus.
• Minimum 3 years of experience as a process, validation, or manufacturing engineer in a manufacturing environment.
• Must possess a hands-on mechanical aptitude.
• Strong interpersonal, oral, and written communication skills with the ability to effectively communicate within the organization, and with customers and suppliers as required.
• Ability to provide accu