Injection Molding Process Engineer

Roles and Responsibilities

• 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.
• Cofluiding 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.

Benefits

• Medical/Dental/Vision Insurance
• Short-Term Disability
• Long-Term Disability
• Life Insurance
• Paid Vacation Days
• 9 Paid Holidays
• 401k
• Onsite Fitness Facility