Required more than 4 years of experience in Plastic Injection Molding, Process development and Manufacturing for ISO regulated manufacturing Medical Device environment. Prior Mold Making, and/or Design experience- required.
Leads tooling projects to ensure alignment with project deliverables. Will manage tooling workload including all new tool designs, tool modifications, and mold troubleshooting.
Lead Design Review meetings for their tools, and insure that all design standards are followed, and documented.
Represents tooling in DFM meetings to communicate any product design requirements that pertain to robust tool design and build. Provides quotes for price and lead time for all tool design and build requirements for composites, injection molding, and elastomers.
Utilizes, monitors and recommends improvements or changes to all systems for the production of Tool Designs required and ensures compliance with structured internal Quality Systems as measured by routine system audits. Properly utilize and maintain digital file storage system to protect and control the electronic data generated
Good knowledge with regulatory requirements (e.g. ISO 13485, ISO 14971, CE & FDA, GMP)
Understanding and implementation in six-sigma manufacturing, green-belt certified, FMEA, control plan, Process automation, Process capability improvement, 5S, kaizen, kanban, poka-yokes, etc.
Ability to prioritize and work independently, Oral and written communication skills