Job Description

Job Summary

The Manufacturing Engineer is a key member of the Operations team and plays a critical role in identifying, coordinating, and implementing process improvement initiatives to reduce operational costs and maximize overall manufacturing effectiveness.

This role is responsible for ensuring products and processes conform to established internal and customer requirements through validation, testing, and continuous improvement activities. The Manufacturing Engineer works cross-functionally with internal teams, customers, suppliers, and technical experts to support manufacturing objectives and operational excellence.

Key Responsibilities

• Apply extensive knowledge of assembly processes and assembly-related technologies
• Conduct time and motion studies to improve efficiency and productivity
• Lead and participate in multi-disciplinary teams to drive continuous improvement initiatives
• Collect, analyze, and interpret data to support operational improvement projects
• Perform ergonomic analyses and implement justified improvements
• Coordinate evaluation, selection, and implementation of new or existing equipment and systems, ensuring proper integration, budget compliance, and support of new program launches
• Develop, execute, and document validation protocols, procedures, and final reports for equipment and processes
• Research and apply relevant industry, engineering, and regulatory standards to establish robust validation approaches
• Collaborate with Operations to ensure proper training of operators on new and existing processes
• Evaluate material and information flow, including creation and maintenance of Bills of Materials (BOMs)
• Identify system issues and coordinate corrective and improvement actions
• Standardize raw materials, equipment, and documentation to reduce process variation
• Analyze critical process control points and develop control strategies, including decision tools to support operators
• Reduce inventory losses and support improvements in inventory accuracy
• Review, update, and implement changes to manufacturing process documentation
• Design, build, or modify fixtures, tooling, automation, and error-proofing (poka-yoke) solutions
• Stay current with existing and emerging automation technologies and process upgrades
• Train technical staff on maintenance and support of manufacturing equipment, including automated and robotic systems
• Develop visual management systems to support shop floor communication and performance tracking
• Lead or participate in corrective action and continuous improvement initiatives using PDCA methodology
• Support plant layout analysis, workforce planning, material flow optimization, standard work development, and ergonomic reviews for new and existing programs

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Industrial, or Biomedical Engineering preferred)
• Minimum of 5 years of experience in a regulated manufacturing or product quality environment preferred
• Prior experience with chemical and/or plastics manufacturing processes preferred
• Strong working knowledge of cGMP requirements
• Experience with FDA and EPA regulations (including 21 CFR 820) preferred
• Proficiency in Microsoft Office and manufacturing management systems
• Strong communication, decision-making, and problem-solving skills
• Ability to work effectively in cross-functional team environments

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