Process Engineer

Job Title: Process Engineer Job Description The Process Engineer develops, validates, and optimizes injection molding processes for high-precision plastic products in a medical device manufacturing environment. This role focuses on scientific molding, process documentation, continuous improvement, and cross-functional collaboration to ensure robust, repeatable, and efficient production in a 24/7 operation.

Responsibilities Develop injection molding processes using proven scientific molding methodologies to support high-precision plastic products. Design, build, and validate injection molding processes, molds, and work cells through IQ, OQ, and PQ validation activities. Document molding processes in detail, including mold setup, work cell layout, and troubleshooting information for each validated job.

Participate in project meetings to keep validation and production projects on track from initiation through completion. Support current production needs by troubleshooting molding issues and driving process improvements. Support and oversee the introduction and production use of new process equipment. Support the creation and implementation of engineering change orders (ECOs) related to processes, tooling, and materials.

Establish robust, repeatable, and reproducible process parameters for new and existing injection molding jobs. Participate in activities aimed at reducing cycle time and improving overall process efficiency. Implement statistical process analysis on new and existing products to monitor performance and identify improvement opportunities. Develop, maintain, and continuously update process documentation to reflect current best practices and validated conditions.

Review and refine processing methods to enhance quality, efficiency, and consistency. Ensure safety standards and internal policies are followed throughout all manufacturing and engineering activities. Leverage industry best practices and apply them to internal systems, processes, and standards. Implement Lean Manufacturing principles and drive continuous improvement initiatives across the production environment.

Maintain a high level of motivation within the area of responsibility and foster a culture of performance and accountability. Plan and organize layouts for line changes driven by volume changes or manpower adjustments. Maintain regular contact with interdepartmental leaders to provide feedback and alignment when dealing with process or material changes. Understand and execute all plant policies and procedures related to production, quality, safety, and employee relations.

Structure and implement area-specific policies and procedures to ensure safe, efficient operation and strong team performance. Develop and maintain positive team member relations based on mutual trust, dignity, respect, fairness, consistency, two-way communication, teamwork, and harmony. Apply root cause analysis techniques to identify, diagnose, and resolve process and equipment issues. Collaborate closely with production, quality, manufacturing engineering, and tooling teams in a hands-on environment.

Essential Skills Minimum of 5+ years of experience in an injection molding operation, preferably in a 24/7 manufacturing or molding environment. Strong plastic injection molding experience, including high precision plastic products and tool design for injection molding. Knowledge of scientific molding principles and proven ability to apply them to process development and optimization. Medical device manufacturing experience and familiarity with requirements for supporting large medical device OEMs.

Experience in manufacturing process engineering, including process development, validation, and improvement. Demonstrated ability to perform root cause analysis and implement effective corrective actions. Good written and verbal communication skills for interaction with internal teams and external customers. Basic knowledge of manufacturing equipment and advanced ability to read prints an