JOB DESCRIPTION

As an Injection Molding Process Engineer, you will provide technical expertise in support of existing operations and new product development and introduction projects. You will establish and maintain manufacturing processes and procedures, including capacity planning, tooling acquisition, replacement plans, process development using scientific injection molding techniques, routings, cost reductions, and quality improvements within the organization. A special focus is placed on Injection Molding, new tool specification, acquisition, debugging, decoupled process development, validation, and new or replacement equipment specification and activities.

Requirements:

• A minimum of five (5) years of related work experience (preferably in the medical device field).
• B.S. degree in an engineering or related field or equivalent experience (Plastics, mechanical, manufacturing, or materials preferred).
• Experience developing injection molding processes using Scientific Injection Molding principles.
• Experience specifying and procuring Injection Molding Tooling, Molding Machines, and Auxiliary Equipment.
• Strong verbal and written communication skills.
• Proficiency in project management software (e.g., MS Project, Smartsheet, Excel, or similar)
• Beginning experience level in SolidWorks.
• Proficiency in Microsoft Office (e.g. Word, Excel, PowerPoint, etc.).
• Must be able to work in a fast-paced environment with little to no supervision.
• Experience with medical process validation, including validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, and measurement systems analysis (MSA), pFMEA, dFMEA.
• The ability to perform statistical analysis (DOE, capability, GR&R, etc.) using Minitab software.
• Experience and understanding of the development and design of plastic parts and assemblies preferred

• Establishing project timelines and driving for the successful completion of projects.
• Direct interface with customers, suppliers, and internal resources in a professional manner.
• Defining and managing the scope, time, budget, and resources of projects.
• Coordinating DFM (Design for Manufacturability/Moldability) with other engineers, external vendors, customers, and internal project teams.
• Leading the validation activities to launch new products and molds into production, including all documentation in accordance with company, FDA, ISO, and customer standards.
• Managing all molding validation activities, including developing validation plans, writing protocols and reports, coordinating metrology and inspections, and communicating with customers.
• Submit, review, and/or approve change orders to implement new or revised existing processes.
• Train production personnel on new and revised processes.
• Technical writing of protocols, reports, work instructions, etc.
• Any other duties or projects as required.

Requirements:

• A minimum of five (5) years of related work experience (preferably in the medical device field).
• B.S. degree in an engineering or related field or equivalent experience (Plastics, mechanical, manufacturing, or materials preferred).
• Experience developing injection molding processes using Scientific Injection Molding principles.
• Experience specifying and procuring Injection Molding Tooling, Molding Machines, and Auxiliary Equipment.
• Strong verbal and written communication skills.
• Proficiency in project management software (e.g., MS Project, Smartsheet, Excel, or similar)
• Beginning experience level in SolidWorks.
• Proficiency in Microsoft Office (e.g. Word, Excel, PowerPoint, etc.).
• Must be able to work in a fast-paced environment with little to no supervision.
• Experience with medical process validation, including validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, and measurement systems analysis (MSA), pFMEA, dFMEA.
• The ability to perform statistical analysis (DOE, capability, GR&R, etc.) using Minitab software.
• Experience and understanding of the development and design of plastic parts and assemblies preferred.