Injection Molding Process Engineer

Biomerics LLC; Mebane (NC); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation Days

9 Paid Holidays

401k

Onsite Fitness Facility

Job summary

Biomerics LLC is seeking an Injection Molding Process Engineer in Mebane, NC, to provide technical expertise for existing operations and new product development. You will establish and maintain manufacturing processes, focusing on injection molding, tooling acquisition, and process validation.

The ideal candidate will have a B.S. degree in an engineering field, five years of relevant experience, and knowledge of medical device processes. Benefits include comprehensive insurance, 401k, and an onsite fitness facility.

Qualifications

• Minimum of five years of related work experience, preferably in medical devices.
• Strong written and verbal communication skills are required.
• Experience in validation activities related to medical processes is essential.

Responsibilities

• Establish project timelines and drive successful project completion.
• Manage the scope, time, budget, and resources of projects.
• Train production personnel on new and revised processes.

Skills

Injection Molding Process Development

Project Management

Statistical Analysis

Technical Writing

SolidWorks

Education

B.S. degree in Engineering or related field

Tools

Minitab

Microsoft Office Suite

MS Project

Smartsheet

Job description

Job Summary

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. 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 the final candidate, if needed.

Responsibilities

• Establish project timelines and drive for the successful completion of projects.
• Direct interface with customers, suppliers, and internal resources in a professional manner.
• Define and manage the scope, time, budget, and resources of projects.
• Coordinate DFM (Design for Manufacturability/Moldability) with other engineers, external vendors, customers, and internal project teams.
• Lead validation activities to launch new products and molds into production, including all documentation in accordance with company, FDA, ISO, and customer standards.
• Manage 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

Biomerics offers Medical/Dental/Vision Insurance, Short‑Term Disability, Long‑Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, and an Onsite Fitness Facility.