Limiting Uncertainty For The Busiest Surgeons
Senior Molding EngineerMansfield, MA
The Senior Molding Engineer will provide technical solutions for all molded / extruded components that are used in Integra products and ensure that designs are optimized for manufacturability and cost.
•Specify, develop, purchase and qualify tooling, fixtures and equipment used in molding operations
•Select and validate new polymer materials for molding and extrusion applications
•Manage the execution of all validation activities associated with new molded/extruded components and assemblies
•Manage the activities performed by Integra’s molding and extrusion suppliers
•Manage and serve as project leader for base business projects that involved polymer materials and molded components, including resolution of quality-related problems with released product that require analysis and implementation of corrective actions
•Research new molding and extrusion suppliers and processes
•Travel as needed to domestic and international vendor sites and company locations
•Other duties as assigned
•Demonstrated expertise in molding technologies and their application in the medical device field.
•A thorough knowledge of medical device design control process.
•Demonstrated expertise in 3D CAD software and molding simulation tools
•Ability to communicate effectively with colleagues, teams, management and external partners.
•Ability to collaborate with and mentor technical staff in molding engineering discipline.
•Ability to serve as project leader for molding related projects
•Minimum of a Bachelor’sdegree in Mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required. Plastics Engineering degree / Master’s degree preferred.
•Minimum 5-7 years’ industry experience in molding and plastics engineering with a B.S. degree OR
•Minimum 3-5 years’ industry experience in molding and plastics engineering with a M.S. degree
•Medical industry product design and molding knowledge required
•Demonstrated expertise in mold and extrusion tooling specifications, design and construction
•Demonstrated expertise in material characteristics and molding processes of medical-grade polymers
•Demonstrated experience in writing and executing molding equipment validations and process validations
•Demonstrated knowledge of ISO13485 Design Control and its application to molded / extruded components
•Demonstrated experience in molding supplier selection, qualification and management
•Experience with hands-on operation of molding machines in an academic or production environment
•Statistical analysis knowledge required, including an understanding of how to execute Design of Experiments (DOE). Six Sigma certification preferred.
•Ability to complete financial analyses for tooling and equipment purchases, estimate processing costs and estimate component costs
•Experience working in integrated cross-functional product development teams
•Strong technical communication skills
•Excellent verbal, written and presentation skills