Tooling Engineer, Medical Device Manufacturing

Intellectt Inc; Tempe (AZ); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Benefits package

Job summary

Intellectt Inc. seeks a Tooling Engineer in Tempe, AZ to design, develop, qualify, and maintain tooling for medical device manufacturing, including injection molds, jigs, fixtures, and automation support.

The ideal candidate will have 5+ years of tooling engineering experience, a BS in Mechanical/Manufacturing/Plastics/Tooling, and proficiency with CAD tools (SolidWorks/Creo/AutoCAD); ISO 13485 knowledge and process validation experience are preferred.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Plastics, or Tooling Engineering.
• 5+ years of tooling engineering experience.
• Experience designing or supporting injection molds, precision tooling, and manufacturing fixtures.
• Proficiency with SolidWorks, Creo, AutoCAD, or similar CAD software.
• Strong understanding of GD&T, machining processes, materials, and precision tolerances.
• Experience supporting tooling qualification and manufacturing process validation.
• Medical device manufacturing experience preferred.
• Knowledge of ISO 13485 and regulated manufacturing change control.

Responsibilities

• Design and develop precision tooling, injection molds, jigs, fixtures, and manufacturing support equipment.
• Work with equipment suppliers and mold makers to develop tooling solutions.
• Review and approve tooling drawings, designs, specifications, and engineering changes.
• Support tool fabrication, testing, qualification, and production release.
• Troubleshoot tooling issues affecting dimensional accuracy, product quality, or production output.
• Conduct tooling design reviews and support design for manufacturability.
• Support mold flow analysis and tooling design improvements where applicable.
• Collaborate with Process Engineering and Quality Engineering teams on tool qualification and process validation.
• Apply GD&T, tolerance stack-up analysis, and precision manufacturing principles.
• Manage tooling maintenance strategies, lifecycle performance, and engineering improvements.
• Develop tooling technical documentation, specifications, and validation support records.

Skills

Tooling Design

SolidWorks

Injection Mold Design

CAD

GD&T

Precision Machining

Manufacturing Fixtures

IQ/OQ/PQ

Mold Flow

Education

Bachelor's degree in Mechanical, Manufacturing, Plastics, or Tooling Engineering

Tools

SolidWorks

Creo

AutoCAD

Job description

Intellectt Inc. seeks a Tooling Engineer in Tempe, AZ to design, develop, qualify, and maintain tooling for medical device manufacturing, including injection molds, jigs, fixtures, and automation support.

The ideal candidate will have 5+ years of tooling engineering experience, a BS in Mechanical/Manufacturing/Plastics/Tooling, and proficiency with CAD tools (SolidWorks/Creo/AutoCAD); ISO 13485 knowledge and process validation experience are preferred.