5+ years of experience in injection molding, preferably in medical device manufacturing
B.S. degree in engineering or related field; plastics/mechanical/manufacturing preferred
Strong knowledge of Scientific Injection Molding techniques
Experience in specifying and procuring injection molding tools and equipment
Proficient in project management software and Microsoft Office
Starting experience level in SolidWorks
Experience with medical process validation and statistical analysis using Minitab
Responsibilities
Establish project timelines and ensure successful project completion
Interface professionally with customers, suppliers, and internal teams
Define and manage project scope, budget, and resources
Coordinate DFM activities with engineers, vendors, and project teams
Lead validation activities for new products and molds
Manage all aspects of molding validation, including developing plans and documentation
Review and approve change orders for process implementation
Train staff on new and revised processes
Conduct technical writing for protocols and reports
Benefits
Potential relocation assistance for the final candidate
Opportunities for professional development and skill enhancement
Working in a fast-paced, innovative environment
Engaging with a collaborative team of professionals
Exposure to cutting-edge manufacturing technologies
Full Job Description
Job Type
Full-time
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.
Key metrics for this position include project on-time delivery, scrap, machine efficiency, cost reductions, and customer satisfaction.
Potential relocation assistance available for our final candidate, if needed.
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.
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 or another highly regulated manufacturing environments with a 13485 ISO minimum ).
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 Plastics, mechanical, manufacturing, silicone/LSR or materials preferred.
