Tooling Engineer

Position Purpose: 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 Expect 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  

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 a plus

WORK ENVIRONMENT: 

Works in an office and clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel  

Occasional travel up to 15% based on assignments