Injection Molding Process Engineer - Weekend Shift

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. At Biomerics we are dedicated to our diverse employee base, recognizing that a strong, skilled, and engaged workforce is the foundation of our continued success. Our core values—integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence—guide every interaction. We foster a team‑oriented, customer‑focused culture that emphasizes strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

About the role

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 include project on‑time delivery, scrap, machine efficiency, cost reductions, and customer satisfaction. Potential relocation assistance is available for the final candidate, if needed.

Responsibilities

• Establish project timelines and drive successful completion of projects.
• Directly 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 engineers, external vendors, customers, and internal project teams.
• Lead validation activities to launch new products and molds into production, ensuring documentation complies 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 processes.
• Train production personnel on new and revised processes.
• Perform technical writing of protocols, reports, work instructions, etc.
• Perform any other duties or projects as required.

Requirements

• Minimum of five (5) years of related work experience, preferably in the medical device field or another highly regulated manufacturing environment with ISO 13485 compliance.
• B.S. degree in engineering or a 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‑level experience with 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 IQ, OQ, PQ, test method definition, root cause analysis, measurement systems analysis (MSA), pFMEA, and dFMEA.
• 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 related materials preferred.