Process Engineer - Injection Molding (Medical Devices, Greensboro)

Gilero, A Sanner Group Company; Greensboro (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental & Vision

Life insurance

Disability insurance

401(k) with company match

LinkedIn Learning

Job summary

Gilero, a Sanner Group company, currently seeks a Process Engineer at our Greensboro, NC facility. You will establish and optimize high-precision injection molding processes for drug delivery and medical device components in ISO 13485/9001 environments, ensuring QA compliance and process validation.

You will lead DOE studies, drive lean initiatives, and collaborate with toolmakers, engineering, and suppliers to deliver high-quality manufacturing outcomes. Travel up to 5% may be required.

Qualifications

• 5+ years of hands-on injection molding experience and expertise in molding processes, tooling, materials, and optimization.
• Bachelor’s degree or equivalent in Engineering or related technical field; work experience may substitute.
• Experience troubleshooting molding processes, identifying root causes, and implementing improvements.
• Experience in a medical white room or ISO Class 7/8 cleanroom preferred.
• RJG Master Molder certification preferred and advantageous.
• Excellent cross-functional communication skills and technical writing abilities.
• Methodical, detail-oriented, and able to follow manufacturing protocols.

Responsibilities

• Develop and optimize injection molded processes; establish, validate, and maintain production processes.
• Ensure validation and compliance with quality protocols for molds, presses, and equipment; write and execute process capability protocols (IQ/OQ/PQ).
• Perform root cause analysis for molding defects and drive continuous improvement and lean initiatives.
• Collaborate with toolmakers on new molds, modifications, and repair needs.
• Write SOPs, validation reports, and manufacturing specifications.
• Comply with FDA and ISO standards; develop DOE-based capabilities for process qualification.
• Establish maintenance requirements for new equipment and assess impact of process changes.
• Support manufacturing investigations and CAPA resolutions; participate in quality audits.

Skills

Injection molding

Troubleshooting

Cross-functional communication

Technical writing

Process optimization

RJG Master Molder certification

Education

Bachelor’s degree or equivalent in Engineering

Tools

Precision hand tools

Job description

Gilero, a Sanner Group company, currently seeks a Process Engineer at our Greensboro, NC facility. You will establish and optimize high-precision injection molding processes for drug delivery and medical device components in ISO 13485/9001 environments, ensuring QA compliance and process validation.

You will lead DOE studies, drive lean initiatives, and collaborate with toolmakers, engineering, and suppliers to deliver high-quality manufacturing outcomes. Travel up to 5% may be required.