Process Engineering Manager

Leads process engineering, validation, and manufacturing improvement activities for medical products, with emphasis on injection molding and Liquid Silicone Rubber processes.

Job Requirements

• Bachelor of Science degree or equivalent relevant experience in process development using scientific principles
• At least 5 years of plastics injection molding experience
• Experience developing and validating manufacturing processes for medical products
• Knowledge of Liquid Silicone Rubber molding processes
• Expertise in scientific molding principles
• Proficiency with Statistical Process Control
• Proficiency with Design of Experiments
• Experience supporting IQ, OQ, and PQ activities
• Knowledge of ISO 13485 requirements
• Experience maintaining records in IQMS or another MRP system
• Experience with engineering document control
• Experience leading a process engineering department
• Project management experience involving manufacturing or process engineering initiatives

Preferred Skills

• RJG Master Molder I or II certification
• Paulson ProMolder certification or equivalent scientific molding certification
• At least 5 years of manufacturing experience
• Experience qualifying processes at one facility and transferring them to additional manufacturing plants
• Experience developing tooling and piece-part cost estimates
• Experience sourcing manufacturing equipment and vendors
• Experience training Process Engineers and Process Technicians

Job Responsibilities

• Lead and manage the Process Engineering team
• Develop, validate, and improve manufacturing methods for medical products
• Apply scientific molding principles to establish capable and repeatable processes
• Develop processes, work instructions, and manufacturing techniques supporting IQ, OQ, and PQ
• Ensure process development, validation, and documentation comply with ISO 13485 and applicable regulatory requirements
• Lead process qualification activities at the primary manufacturing facility
• Transfer standardized processes to additional plants
• Establish standard work, training materials, and sustainment plans for transferred processes
• Compile and organize engineering and design specifications
• Prepare cost estimates and quotations for piece parts and tooling
• Coordinate process information with manufacturing, tooling, quality, material control, and commercial departments
• Prepare and validate manufacturing data for electronic processing
• Perform engineering calculations and monitor processing outputs for accuracy
• Develop production processes and standards that meet quality specifications
• Provide technical support for manufacturing, quality, application engineering, and commercial operations
• Investigate and resolve manufacturing and customer processing issues
• Create development plans for Process Engineers
• Support technical training and skill development for Process Technicians
• Prepare engineering reports and maintain process records, files, and procedural documentation
• Identify, evaluate, and source vendors and manufacturing equipment
• Track safety, quality, delivery, and cost performance

Pay Details: $140,000.00 to $150,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

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