Manufacturing Engineer, Medical Devices & DFM

I3 INFOTEK INC; Plano (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

I3 INFOTEK INC is seeking a Manufacturing Engineer with 3–4 years of experience in medical devices manufacturing. You will develop and optimize production processes, validate processes (IQ/OQ/PQ), and contribute to continuous improvement initiatives.

The role requires collaboration across teams in a fast-paced environment, strong communication skills, and adherence to FDA, ISO 13485, and GMP requirements. This position is on-site in Plano, TX.

Qualifications

• Bachelor’s degree in mechanical or manufacturing engineering or equivalent.

Responsibilities

• Develop and optimize manufacturing processes and technologies.

Skills

Manufacturing process development

Lean Manufacturing

Process Validation & FMEA

Root Cause Analysis

Tooling & Equipment design

Design for Manufacturability

Production troubleshooting

Quality systems knowledge

Education

Bachelor’s in mechanical engineering or manufacturing engineering or equivalent

Tools

Minitab

Job description

I3 INFOTEK INC is seeking a Manufacturing Engineer with 3–4 years of experience in medical devices manufacturing. You will develop and optimize production processes, validate processes (IQ/OQ/PQ), and contribute to continuous improvement initiatives.

The role requires collaboration across teams in a fast-paced environment, strong communication skills, and adherence to FDA, ISO 13485, and GMP requirements. This position is on-site in Plano, TX.