Injection Molding Process Engineer

Biomerics; Mebane (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Short-term Disability

Long-term Disability

Paid Vacation

9 Holidays

Job summary

Biomerics is seeking an Injection Molding Process Engineer to provide technical expertise in support of existing operations and new product development. You will establish manufacturing processes, including capacity planning, tooling acquisition, process development, and quality improvements within the organization.

A focus includes new tool specs, debugging, validation, and equipment planning. Key metrics include on-time delivery, scrap reduction, machine efficiency, cost reductions, and

Qualifications

• Minimum five years of related work experience, preferably in medical devices.
• BS degree in engineering or related field; plastics/manufacturing/materials preferred.
• Experience developing injection molding processes using Scientific Injection Molding principles.
• Experience specifying and procuring injection molding tooling and auxiliary equipment.
• Strong verbal and written communication skills; proficiency with project management tools.

Responsibilities

• Establish project timelines and drive for successful completion.
• Interface with customers, suppliers, and internal resources professionally.
• Define and manage scope, time, budget, and resources.
• Coordinate DFM with engineers, vendors, customers and teams.
• Lead validation activities to launch new products and molds, with documentation per standards.
• Manage molding validation, develop validation plans, write protocols and reports, coordinate metrology and inspections.
• Submit and approve change orders to implement new or revised processes.
• Train production personnel on new and revised processes.
• Write protocols, reports and work instructions.
• Perform other duties as required.

Skills

Injection molding

Project management

Statistical analysis

MS Office

Education

Bachelor's degree in engineering

Tools

MS Project

Smartsheet

Excel

Minitab

Job description

Company Overview

Biomerics is a world‑class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We focus on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

Job Type

Full‑time

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 and 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.

Roles and 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.
• Write technical documentation such as protocols, reports, and work instructions.
• Perform any other duties or projects as required.

Requirements

• 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 (Word, Excel, PowerPoint, etc.).
• Ability 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.
• 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, 401(k), and an Onsite Fitness Facility.