Manufacturing Engineer I - Plastics Engineer

Position Overview

Engineer I is the entry level engineering position for manufacturing engineering. The engineer will work under direct supervision of a manager and/or more experienced team members to support improvements in manufacturing quality, capacity, and stability through solving problems, developing solutions, and executing strategies. This position is intended to prepare engineers new to the medical device industry for advancement to Engineer II. In this role, you will engage in day-to-day production support, develop, maintain, and improve production processes while optimizing injection molding processes for plastic components to ensure high-quality production, cost efficiency, and compliance with industry standards.

Key Responsibilities

• Develop and validate injection molding processes for new and existing products.
• Establish and maintain process parameters to ensure consistent quality and efficiency.
• Implement lean manufacturing principles and continuous improvement strategies.
• Collaborate with tooling vendors for mold design, maintenance, and improvements.
• Specify and procure injection molding machines, auxiliary equipment, and automation systems.
• Participate in equipment development, support the creation of User Requirement Specifications (URS), and assist with Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) activities.
• Troubleshoot tooling and equipment issues to minimize downtime.
• Develop and maintain process documentation, including work instructions, process monitoring sheets, and pFMEAs.
• Conduct root cause analysis and implement corrective actions for defects and process deviations.
• Provide support for CAPA (Corrective Action and Preventive Action) and non-conformance (NC) efforts as assigned.
• Ensure compliance with new QMSR and customer requirements.
• Work closely with product development and design engineering to ensure manufacturability of plastic parts.
• Act as subject matter expert for plastics engineering activities to support new product introduction (NPI) and participate in design reviews.
• Provide technical guidance to production teams and train operators on best practices.
• Monitor key performance indicators (KPIs) such as cycle time, scrap rate, and efficiency.
• Prepare reports and present findings to management for decision-making.
• Perform other duties as assigned.

Required Qualifications

• Bachelor’s Degree or higher in Plastics Engineering, Mechanical Engineering, Manufacturing Engineering, or a related discipline.
• 0 years of experience required.
• Proactive learner.
• Strong knowledge of polymer materials and their properties.
• Must have good interpersonal and communication skills.
• Proficient in CAD, Word, Excel, and PowerPoint.

Preferred Qualifications

• Knowledge of scientific molding principles.
• Certification in plastics engineering or a related field.