Process Engineer

Your Job

As a Process Engineer based in Costa Mesa, California, you will develop, validate, improve, and sustain manufacturing processes for injection-molded and over molded medical-device and cable-assembly products. You will serve as the technical owner for molding and over molding processes from concept through production release, helping deliver safe, capable, efficient, and compliant manufacturing operations.This role provides technical leadership for new product introductions, process transfers, tooling development, scientific molding studies, process validation, and continuous improvement. The primary focus is thermoplastic injection molding and component or cable over molding.

Our Team

You will collaborate 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 translating technical challenges into practical, production-ready manufacturing solutions.

What You Will Do

• 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, and 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 qualification, operational qualification, and performance qualification activities
• Author and review engineering protocols, 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

Who You Are (Basic Qualifications)

• Bachelor’s degree in mechanical engineering, manufacturing engineering, plastics engineering, industrial engineering, or another engineering discipline
• 5+ years of manufacturing or process engineering experience
• 3+ years of hands-on thermoplastic injection-molding or over molding 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

What Will Put You Ahead

• 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 qualification, operational qualification, 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

This role is not eligible for VISA Sponsorship.

For this role, we anticipate paying $105,000 - $120,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.

Our Benefits

Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.