Process Engineer - Plastic Injection Molding
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.
Responsibilities:
- Serve as a Subject Matter Expert (SME) for injection molding systems.
- 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 Certification 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 prefered
- Occasional travel up to 15 percent based on assignments; domestic and international
- Ability to lift 55lbs