Injection Molding Process Engineer for Medical Devices

Biomerics; Winston-Salem (NC); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Biomerics in Winston-Salem, NC, is seeking an Injection Molding Process Engineer to support existing operations and new product development. You will establish and maintain manufacturing processes, tooling, capacity planning, and cost reductions to improve quality and efficiency.

You will lead validation activities, coordinate DFMs with cross-functional teams, and ensure documentation meets FDA/ISO standards while driving on-time project delivery.

Qualifications

• Minimum of five years of related experience in medical device manufacturing.
• B.S. degree in engineering or related field.
• Experience developing injection molding processes using Scientific Injection Molding.
• Experience specifying and procuring Injection Molding Tooling and equipment.
• Strong verbal and written communication skills.

Responsibilities

• Establish project timelines and drive completion.
• Direct interface with customers, suppliers, and internal resources.
• Define and manage scope, time, budget, and resources.
• Coordinate DFM with engineers, vendors, customers, and internal teams.
• Lead validation activities to launch new products and molds.
• Train production personnel on new processes.
• Develop protocols and reports; manage change orders as needed.

Skills

Project management

Technical writing

Statistical analysis (DOE/GR&R)

Communication skills

Education

B.S. in Engineering

Tools

MS Project

Smartsheet

Excel

SolidWorks

Minitab

Job description

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 are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.

We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

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.