Manufacturing Engineer I - Plastics Engineer

Job Description

Job Description

Engineer I is the entry level engineering position for manufacturing engineering. The engineer will work under the direct supervision of a manager and / or more experienced team members, to support the improvements in manufacturing quality, capacity, and stability through solving problems, developing solutions, and executing strategies. The position is intended to prepare engineers new to the medical device industry for advancement to the next level of Engineer II.

The Engineer I role is responsible for day-to-day production support, developing, maintaining and improving production processes. This role will be responsible for supporting and optimizing injection molding processes for plastic components used in manufacturing operations. This role ensures high-quality production, cost efficiency, and compliance with industry standards while driving continuous improvement initiatives.

Essential Duties and 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, provide support of User Requirement Specification (URS) creation, 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 corrective actions for defects and process deviations.
• Provide support for CAPA (Corrective Action and Preventive Action), and NC’s (Non-conformances) 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 Job Qualifications :

Preferred Job Qualifications :

Physical / Mental Demands :