The candidate for this position will be responsible for the coordination of all continuous improvement process within molding area: Production, Quality, Maintenance, Logistics, Packing and Engineering jobs on molding injection projects and other production areas related. Please don't apply if you don't have experience on Molding area.
Responsibilities
- Plan, develop, implement and coordinate new molding development activities as well as changes to existing manufacturing processes related to the molding area.
- Check and control the budget for molding projects.
- Coordinate the development of new molding processes by interfacing with internal and external personnel from R&D, technology, product design, product development, quality, production, manufacturing, process/assembly technology and outside mold/molding vendors.
- Coordinate with Quality qualification and validation activities for new products, processes, changes and transfers as per FDA regulations (IQ, OQ and PQ).
- Contribute to the specification of new equipment, molds and materials for new molding processes, existing processes, or changes ensuring part designs can be injection molded reliably.
- Install new equipment and molds to support new product development, existing molding/manufacturing process changes, replication or scale-up.
- Analyze new and existing manufacturing processes and recommend improvements to maximize quality and productivity. Implement approved recommendations by fabricating custom fixtures, creating necessary documentation, directing efforts of outside resources.
- Initiate Device History Record (documentation required for manufacturing)
Qualifications
*Bachelor’s degree in engineering or other technical discipline. Formal knowledge of CAD software (Solid Works and Master Cam).
*Knowledge of the injection molding process (practical is a plus), scientific molding theory and procedures, statistical techniques (DOE, SPC, Six Sigma), Minitab is a plus.
*Bilingual English/Spanish
*At least 2 years of experience in a manufacturing environment. Experience within the medical manufacturing industry.