Process Engineer

Koch • Costa Mesa, CA

18d

About The Position

The Process Engineer, based in Costa Mesa, California, develops, validates, improves, and sustains manufacturing processes for injection-molded and overmolded medical-device and cable-assembly products. The role is the technical owner for molding and overmolding processes from concept through production release, helping establish safe, capable, efficient, and compliant manufacturing operations. It provides technical leadership for new product introductions, process transfers, tooling development, scientific molding studies, process validation, and continuous improvement, with a primary focus on thermoplastic injection molding and component or cable overmolding.

The engineer collaborates with manufacturing operations, quality, project engineering, tooling and equipment suppliers, customers, technicians, and other cross-functional partners. The team supports new-product development and existing production by turning technical challenges into practical, production-ready manufacturing solutions.

Requirements

• Bachelor’s degree in mechanical engineering, manufacturing engineering, plastics engineering, industrial engineering, or another engineering discipline.
• At least 5 years of manufacturing or process engineering experience.
• At least 3 years of hands-on thermoplastic injection-molding or overmolding experience.
• Experience with scientific molding, thermoplastic material behavior, material drying, process-window development, design of experiments, capability analysis, root-cause analysis, or process validation.
• Experience developing or sustaining manufacturing processes in a production environment.

Nice To Haves

• Experience in medical-device or another regulated manufacturing environment.
• Experience with cable-assembly molding and overmolding.
• Experience with silicone molding or silicone overmolding.
• Experience with insert molding, multi-shot molding, automation, robotics, or vision-inspection systems.
• Experience with installation, operational, and performance qualification validation activities.
• Experience with SolidWorks or equivalent computer-aided design software.
• Experience applying Lean or Six Sigma methods to improve scrap, cycle time, yield, capacity, or manufacturing cost.

Responsibilities

• Develop and optimize thermoplastic injection-molding and overmolding processes using scientific molding principles, design of experiments, capability studies, and data-driven analysis.
• Lead molding process development for new product introductions, product transfers, prototype builds, validation activities, production launches, and sustaining products.
• Establish robust process windows and resolve molding defects, including flash, short shots, sink, voids, burns, flow lines, delamination, cosmetic issues, and overmold bonding failures.
• Support mold design reviews and design-for-manufacturability activities; coordinate mold fabrication, qualification, debugging, acceptance, and production readiness.
• Specify and qualify molding machines, fixtures, automation, auxiliary equipment, material-handling systems, and inspection equipment.
• Develop and execute engineering and validation studies, including equipment qualification and installation, operational, and performance qualification activities.
• Author and review engineering and validation protocols, final reports, process documentation, risk assessments, process failure mode and effects analyses, control plans, and process-change assessments.
• Lead root-cause analysis, corrective actions, and improvements related to scrap, defects, cycle time, overall equipment effectiveness, yield, capacity, cost, and recurring process disruptions.
• Train technicians, operators, and engineering personnel on new or revised processes and monitor sustained process capability after implementation.

Benefits

• Medical, dental, and vision insurance.
• Flexible spending and health savings accounts.
• Life insurance, accidental death and dismemberment coverage, and disability coverage.
• Retirement benefits.
• Paid vacation/time off.
• Educational assistance.
• May include infertility assistance, paid parental leave, and adoption assistance, subject to eligibility and applicable policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level