Process Engineer

Essential Job Functions:

• 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.
• Apply Scientific Injection Molding principles to new/current processes by directly running Injection molding machines when needed.
• 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.

Other Job Functions:

• 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.

Experience, Knowledge, Skills, and Abilities required:

• Degree in plastics, manufacturing, industrial, or mechanical engineering required.
• Knowledge of Lean Manufacturing.
• Knowledge working with IQMS or similar Enterprise Resource Planning (ERP) software.
• 4+ years of experience in manufacturing or industrial engineering preferred.
• 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 in operating Injection Molding Machines. 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.
• Processing skills required for Injection Molding and Secondary Operations
• 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.

Work Environment/Physical Requirements:

• Ability to stand for long periods of time.
• Ability to work at desk for extended periods of time.
• Able to push, pull, lift, and carry up to 50 pounds.
• Standing, walking, bending, reaching, kneeling.
• Possibility of exposure to noise, uncontrolled temperatures, and chemicals

Job Summary

Responsible for determining and implementing best manufacturing practices for current and future production related to set-up, start-up, processing, and maintenance of injection molding machines to satisfactorily accomplish quality and on-time delivery of products to customers. Adheres to all plant and OSHA safety policies and regulations.