Process Engineer

Craftech•Ontario, CA
•$75,000 - $100,000

About The Position

The Process Engineer develops and implements stable molding processes and controls to ensure consistent parts and compliance with quality standards. The role maximizes process efficiency and supports plastics manufacturing and secondary processes. It performs mold validations, investigates and resolves work-in-process problems, and contacts suppliers to help correct equipment problems. The position supports the Engineer, Production, and Program Manager teams and promotes a self-motivated, teamwork-oriented environment. The Process Engineer provides engineering support for product design and development, manufacturing processes, and material characteristics. The role leads and participates in process improvement, coordinates mold validations and testing, evaluates opportunities for automation and efficiency, supports tooling improvements, trains and mentors technicians and operations personnel, and works across Engineering, Production, Quality, Maintenance, Tool Room, customers, and suppliers. It also helps ensure preventive maintenance, project deadlines, customer requirements, documentation accuracy, and workplace safety.

Requirements

  • Bachelor of Science degree or equivalent experience.
  • More than 5 years of engineering experience in a medical manufacturing environment.
  • RGJ Master Molder 1 Certification.
  • Advanced knowledge of engineering plastics, resins, and polymers.
  • Good verbal, written, and presentation skills, with the ability to work in a cross-functional team environment.
  • Extensive knowledge of injection molding machines and accessory equipment, including robots, grinders, water systems, and water treatment.
  • Mechanical skills; ability to read part prints and use measuring equipment such as calipers and comparators.
  • Good communication skills and basic computer skills.
  • In-depth knowledge of multi-component molding, design of experiments, basic statistics, insert molding, mold-flow analysis, and process monitoring tools and techniques.
  • Awareness of, agreement with, and support for company values and goals.
  • Knowledge of general safety, IQMS, electrical equipment operation, document and records control, compliance management, blueprint reading, and customer service.

Nice To Haves

  • RGJ Master Molder 2 Certification.
  • FimmTech Certification.
  • Experience and knowledge of Statistical Process Control (SPC) principles, Multi-variable Analysis (MVA), and injection molding process data collection and analysis systems.

Responsibilities

  • Develop, design, and set up robust molding processes using scientific and decoupled molding, including SMPD, DOE, OQ, and PQ runs.
  • Create documentation for molding setups, processes, and workflows.
  • Quantify process capabilities to establish a foundation for evaluating and improving processes and products.
  • Improve production efficiency by reducing cycle times and scrap, improving setup time, workstation layout, and yield, and implementing cGMP.
  • Troubleshoot defects, determine root causes, and identify process or mold changes to prevent recurrence.
  • Audit processes to verify that documented processes match actual practices.
  • Ensure Setup and Process Technicians process jobs correctly.
  • Maintain current Part Number Info in the database.
  • Respond to customer complaints and implement corrective actions when needed.
  • Provide advanced engineering support for product design, manufacturing processes, and material characteristics.
  • Lead process improvement teams using methods such as Lean, Kaizen, Six Sigma, and cGMP.
  • Coordinate mold validations and tests with Scheduling, Molding, Tool Room, and Quality; evaluate processes for automation, cycle efficiency, and labor reduction.
  • Work with the Tool Room to improve the manufacturing capabilities of new and existing tooling.
  • Train and mentor Process Technicians, setup personnel, and key operations personnel.
  • Work with Engineering, Production, Quality, and Maintenance to establish, execute, and monitor preventive maintenance programs.
  • Support the Program Manager in meeting project deadlines.
  • Lead, participate in, or support continuous improvement activities.
  • Work with vendors, suppliers, customers, and outside technical resources to improve manufacturing methods, reduce product cost, and improve product performance.
  • Collaborate with internal and external customers during product development to ensure products meet part-print and functional requirements.
  • Work with the Tool Development Engineer, Tool Room Manager, Production Manager, Maintenance Manager, and Quality Manager to maintain teamwork.
  • Help ensure a safe work environment and participate in safety programs.
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