Lead the engineering functions in support of the design, development and manufacturing scale-up of medical and pharma products.
Identification and selection of plastic materials for ongoing development and material obsolescence.
Identification, selection and installation of primary and secondary processing equipment.
Critique of part designs for Design for Manufacturability and optimum molding performance including use of simulation software to assess manufacturability.
Critique new tool designs for robust mechanical design and optimum molding performance.
Ability to trouble-shoot tooling and process issues with established platforms.
Coordinate activities with external suppliers, molders, tool makers, and material suppliers.
Support tooling debug and process development with suppliers.
Responsible for development of processes that consistently yields parts conforming to specifications.
Create and execute design of experiments to establish robust manufacturing process performance.
Conduct technology transfer of new products and processes.
Evaluate new plastics and processing technologies.
Lead process qualifications and validations with generation of appropriate documentation.
Scope of Position:
Function as the US Engineering representative in a matrix organization across development teams, manufacturing scale-up, and maintenance of business function.
An individual contributor responsible for the technical direction of the team in areas of plastics engineering. Can provide daily direction to technical team members and processing technicians if required.
Ability to work as a member of a cross-function team for both development and manufacturing scale-up activity.
Drive activities with external suppliers, molders, tool makers, and material suppliers.
Responsible for communication will engaged manufacturing sites
BS Plastics Engineering, Chemical or Mechanical Engineering, 7-12 years in Engineering.
Design software (SolidWorks or AutoCad).
Mold flow simulation software
[ISO-9000, GMP, Six sigma, DOE]
Experience in direct support of development and manufacturing.
Demonstrated skills in plastic components design, injection mold tooling expertise, tight tolerance process development and validation.
Project / team management and familiarity with FDA regulated products.
Strong troubleshooting and analytical capabilities with experience in DOE.
Experience with Design for Manufacturing concepts, working knowledge of materials and injection molding fabrication methods.
Position requires strong communication and interactive skills, capable of working independently or on project teams as required.
Familiar with Product & Process Development Phase/Gate Methodology.