Tooling Engineer

Automated Systems, Inc.; Buffalo Grove (IL); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading company in the Pharma/Biotech sector is seeking an Injection Molding Engineer to manage the lifecycle of injection molds for medical devices. This hands-on role involves leading engineering efforts from design to fidelity, ensuring quality and compliance with industry standards while collaborating across teams. Candidates should have a Bachelor's degree in Engineering and substantial experience in high-volume injection molding.

Qualifications

• 5+ years of related experience in industrial manufacturing.
• Experience in qualification of complex and tight tolerance injection molding.
• Knowledge of cGMP / ISO 13485 compliant environments preferred.

Responsibilities

• Lead development, installation, and validation of injection molds.
• Prepare tooling specifications and vendor selection analysis.
• Coordinate mold qualification activities with internal and external teams.

Skills

Communication

Problem Solving

Lean Manufacturing

Statistical Methods

Education

Bachelor's Degree in Engineering

Technical degree or equivalent experience

Job description

Full time | Automated Systems, Inc. | United States

Posted On 06/06/2025

Job Information

Pharma/Biotech/Clinical Research

$100-$130k

State/Province

Illinois

City

Buffalo Grove

60089

Job Description

ONSITE - Full Time

This is a “hands-on” engineering position responsible for leading the development, installation, validation, ramp-up, and life cycle management of injection molds and molding solutions for medical device components.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

• Responsible for preparing tooling specifications for supporting requests for quotes and supporting vendor selection activities, including the analysis of mold design/build costs.
  
• Responsible for ensuring that injection molds can produce parts that meet customer requirements while providing for internal manufacturing robustness.
  
• Coordinate implementation of cost-effective mold design changes.
  
• Collaborate with internal and external team members in completing mold qualification activities (DQ/FAT/IQ/OQ/PQ).
  
• Ensure that cost, quality, timelines, and internal & external customer expectations are managed appropriately.
  
• Perform Design for Manufacturability reviews with the mold supplier and customer
  
• Coordinate tool repair and refurbishment activities as needed.
  
• Investigate and benchmark new tooling, peripherals, and molding technologies
  
• Support tool maintenance to investigate and fix major issues on existing tools. Consultant on complex tooling issues.
  
• Track equipment performance metrics and manage ramp-up action plan to achieve operational performance targets.
  
• Seek feedback from the floor on what works/doesn’t work and develop improvement action plans
  
• Ensure compliance with industry standards and corporate engineering guidelines.
  
• Serve as Subject Matter Expert supporting general business needs as required.
  
• Lead root cause investigations and corrective action implementation.
  
• Support lean and continuous improvement initiatives.
  
• Follow all safety procedures, including the use of Personal Protective Equipment as required.
  
• Other duties as assigned
  

Requirements

• Bachelor's Degree in Engineering,Technical degree, or equivalent experience
  
• Industrial manufacturing experience working in high-volume injection molding
  
• 5+ years of related experience
  
• Experience in the qualification of complex and tight tolerance injection molding
  

PREFERRED KNOWLEDGE/SKILLS:

• Must have clear and well-organized oral and written communication
  
• Knowledge of statistical methods (Six Sigma, SPC, DoE)
  
• Excellent problem-solving skills using DMAIC methodology
  
• Experience working in a cGMP / ISO 13485 compliant manufacturing environment
  
• Mold Maker Certification or similar is a plus