Process Engineer

Clayens US LLCCrystal Lake, IL
Onsite

About The Position

The Process Engineer will be responsible for developing, implementing, maintaining, and improving current injection molding processes. This includes optimizing equipment, documentation, training, gages, and tooling/fixtures to enhance quality, productivity, and cost performance. The role involves planning, specifying, selecting, validating (IQ/OQ/PQ), and implementing new or existing molds and injection molding machines (IMMs) for manufacturing. The Process Engineer will monitor process parameters that may lead to non-conforming products, low yields, or quality issues, and will collaborate with Quality and Engineering Departments to resolve manufacturing production issues. Additionally, the position requires evaluating and improving manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling, and materials, while ensuring compliance with safety standards and legal regulations. Leadership and training responsibilities include mentoring other engineers and technical staff, providing training for Process Technicians, and developing technical training and documentation. The role also supports quoting activities, adheres to safety policies, and maintains a clean and organized work area. Other duties include evaluating quality control processes, analyzing production data for management reports, and planning workflow and equipment placement for efficiency.

Requirements

  • Degree in plastics, manufacturing, industrial, or mechanical engineering required.
  • Knowledge of Lean Manufacturing.
  • Knowledge working with IQMS or similar Enterprise Resource Planning (ERP) software.
  • Experience evaluating, performing root cause analysis, and troubleshooting manufacturing processes and machinery.
  • Strong organization and management skills.
  • Knowledge of ISO13485:2016 and FDA 21 CFR part 820 (CGMP).
  • High level of technical expertise.
  • Experienced with RJG technology and de-coupled molding techniques.
  • Strong analytical thinker.
  • Highly motivated & energetic with a strong work ethic
  • Proven ability to use Microsoft Office Suite – Excel, Word, PowerPoint.
  • Ability to read and understand blueprints.
  • Must have excellent attendance record.
  • Ability to work safely and with minimal supervision.
  • Ability to clearly communicate and interact with all levels of personnel professionally.
  • Ability to follow written and verbal directions and complete work independently.
  • Ability to adhere to workplace rules.

Nice To Haves

  • 4+ years of experience in manufacturing or industrial engineering preferred.

Responsibilities

  • Develop, implement, maintain, and improve current injection molding processes, including equipment, documentation, training, gages, and tooling/fixtures, to optimize quality, productivity, and cost performance.
  • Plan, specify, select, validate (IQ/OQ/PQ), and implement new/existing molds and IMMs for manufacturing.
  • Monitor performance of process parameters that produce non-conforming products, low yields, or product quality issues. Interfaces with Quality and Engineering Departments to resolve manufacturing production issues.
  • Evaluates, creates, and improves manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling, and materials.
  • Ensure manufacturing processes, equipment, and products comply with safety standards and legal regulations.
  • Provide leadership to a project team as assigned, mentor/lead other engineers and technical staff.
  • Provide leadership and training for Process Technicians on the Manufacturing floor.
  • Develop technical training and documentation for manufacturing new and existing products.
  • Assist in maintaining FDA/ISO Quality Standards plant-wide.
  • Engage with the appropriate personnel in the identification and resolution of Corrective/Preventative actions to address Safety, Quality, Technical, and Manufacturing issues.
  • Supports quoting activities for feasibility of manufacturing and cycle time estimates.
  • Adheres to safety policies and strives to maintain our outstanding safety record.
  • Keeps work area, tools, supplies and equipment clean and organized.
  • Performs other job-related and department-related duties as assigned.
  • Evaluate quality control processes and make recommendations for improvements in quality control.
  • Analyze production processes, schedules, methods, and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.
  • Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency.
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