Project Engineer

Key Responsibilities

• Serve as the primary point of contact for customer communication regarding project status, timelines, delivery requirements, and qualification activities.
• Manage customer projects from initial tooling and product development through production realization.
• Cooky construction projects to ensure schedules, quality objectives, and customer expectations are achieved.
• Review mold and tooling designs to improve manufacturability, quality, and production outcomes.
• Perform Design for Manufacturability (DFM) reviews for new product opportunities.
• Review and manage engineering changes, tooling modifications, gauges, fixtures, and jigs.
• Lead project meetings with customers and internal teams to communicate status, risks, and action plans.
• Prepare technical documentation and support quotation packages.
• Manage qualification projects in collaboration with Quality Assurance teams.
• Support implementation of manufacturing and engineering programs designed to improve operational performance.
• Aid with equipment selection, implementation, and facility improvement initiatives.
• Provide technical input regarding project costs, feasibility, tooling requirements, and manufacturing processes.
• Support molding operations through timely coordination of materials, supplies, and components.
• Drive continuous improvement initiatives across molding, tooling, printing, and manufacturing operations.
• Support implementation and maintenance of company quality objectives, including compliance with ISO 13485:2016 and applicable industry standards.
• Promote safe work practices and support compliance with OSHA requirements.

Required Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Proficiency with Microsoft Office applications, including Excel, Word, Project, and Outlook.
• Strong project management and organizational skills.
• Able to effectively communicate with customers, suppliers, and cross-functional teams.

Preferred Qualifications

• Experience in a manufacturing or engineering environment.
• Experience with precision injection molding processes and tooling.
• Knowledge of plastic injection molding applications for medical devices.
• Experience supporting medical device manufacturing and qualification processes.
• Experience with quality systems and ISO 13485 requirements.
• Strong understanding of safety procedures and OSHA practices.
• Project management experience from concept through production launch.
• Experience with cost analysis and manufacturing feasibility reviews.
• SOLIDWORKS proficiency.
• Spanish speaking, reading, and writing ability is a plus.