Technical Operations Engineer
TekniPlex

SUMMARY/PURPOSE

 

The Technical Operations Engineer is responsible for managing and executing assigned Level 1 & 2 technology projects utilizing the knowledge management system.  The engineer will handle projects related to existing products, new compound development, and validations of products, processes, and raw materials.  The engineer will also provide, when needed, technical leadership and expertise to support manufacturing operations Level 0 projects such as continuous improvement, plant optimization, and customer complaint and internal reject investigations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Level 1 & 2:

• Collaborate with chemists and R&D team and make recommendations regarding modifications of existing and standard PVC and TPE compounds formulations.
• Work closely with customers to develop products and processes within the current capabilities of Tekni-Plex Medical.
• Compose and execute process validation protocols and reports for new compounds, modifications to existing compounds, raw materials, and processes with support from the Manufacturing Engineering Team.
• Manage projects in the manufacturing plant and laboratory with a hands-on approach for processing, sampling, and testing.
• Work with the sales and product marketing teams to ensure lead times and capabilities are accurate to the organization’s competency. Provide technical input during project initiation phase for scope and schedule.  Work to ensure that projects remain within scope, time, and cost as proposed in the project plan.
• Work with sales and manufacturing operations to evaluate, analyze, and determine process improvements that impact the “bottom line”.
• Support the transfer of completed technology projects into operations, including providing process history documentation and supporting oversight during manufacturing transition phase.

Level 0:

• Provide technical support to the operations team on continuous improvement and plant optimization projects by reviewing project plan, researching prior knowledge, coordinating and/or conducting required testing, and confirming the quality of the compound.
• Assist with root cause investigation, with a six sigma approach, of escalated rejects and customer complaints that require technology input.
• Collaborate with operations to determine the most appropriate corrective actions for findings that have been identified through internal rejects, customer complaints, and audits.
• Analyze manufacturing methods used and identify improvement opportunities in process capability, productivity, quality, and conversion.
• Compose process validation protocols for plant equipment changes.
• Provide support and training to the sales team when required.

 

Quality:

• Complete assigned ISO internal audits and share findings with the Quality Manager and department manager.
• Manage assigned non-conformances by determining the root cause and implementing the appropriate corrective action.
• Ensure all work instructions and forms related to technical operations are controlled and accurate.
• Incorporate ASTM and ISO standards through the product life cycle, designing and developing the required inspection and process control methodologies.

Knowledge Management:

• Input all projects onto the Knowledge Management log for review during technical and process engineering meetings.
• Record project scope, results, and findings with attention to detail utilizing the knowledge management system.
• Store all completed projects on a shared site for access by the global technical and operations teams.

All other duties as assigned.

·      A Bachelor’s degree in a related engineering field such as mechanical or industrial engineering is required or 5+ years in an extrusion manufacturing environment with process competency. A solid knowledge of plastics is preferred.

·      Extensive experience with process development.

·      Background must include experience in more than one of the following areas: medical device manufacturing, extrusion, injection molding, process improvement, industrial manufacturing.

 

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