Processing Lead

This is a “hands on” lead engineering position responsible for both individual assignments and managing a team of Process Engineers in the development, installation, validation, ramp-up, and life cycle management of injection molds and molding solutions for medical device components.

Responsibilities:

• Serve as a Subject Matter Expert (SME) for injection molding systems.
• Manage and organize the activity of the Process Engineer’s: planning, organization of work, definition and monitoring of workloads, monitoring and communication of its indicators.
• Develop a robust and repeatable process window based on scientific process engineering principles.
• Implement statistical process analysis on new and existing molds.
• Document all injection molding system set-up requirements in Process Information Books and one-point lessons.
• Trouble shoot process related issues through a structured DOE.
• Support the development of new injection molds by participating in mold design reviews and mold factory acceptance trials.
• Support the production ramp-up phase for new products and train appropriate personnel as needed.
• Lead Factory Acceptance Testing (FAT) at domestic and European mold vendors.
• Track process performance metrics and manage ramp-up action plan to achieve operational performance targets.
• Manage multiple programs with continuous collaboration with the project teams.
• Investigate and benchmark new tooling, peripherals, and molding technologies.
• Contribute to the development of specifications for the procurement of new injection molding machines and auxiliaries.
• Perform the initial set-up and establish the standards for injection molding systems.
• Implement safety, productivity, and yield improvements.
• Provide continuous development of manufacturing techniques that will improve in-house capabilities.
• Participate with 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.
• Maintain good housekeeping of both office and factory workspaces.

Work in ISO7 and ISO8 controlled environments with cGMP gowning requirements.

Preferred/Required Education/Skills:

• Engineering, technical degree or equivalent
• RJG Master Molder I & II Certification strongly preferred
• Process Engineering experience working in high-volume plastic injection molding
• Industrial manufacturing experience working in high-volume injection molding
• Experience in the qualification of complex, tight tolerance injection molds (2-shot Cube mold technologies)
• Must have clear and well organized oral and written communication
• Knowledge of statistical methods (6 Sigma, SPC, DoE)
• Excellent problem solving skills using DMAIC methodology
• Experience working in a cGMP / ISO 13485 compliant manufacturing environment
• Occasional travel up to 15 percent based on assignments; domestic and international
• Ability to lift 55lbs

ADDITIONAL NOTES

This Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee and may be revised at any time by the Company.