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  POSITION REQUIREMENTS:  Bachelors Degree in Engineering, Technical degree or equivalent experienceIndustrial 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 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