Project Engineer

This position reports to the Manager of Research & Development. General responsibilities include development of new products and processes, maintenance or improvements and cost reduction of existing products and processes, and assurance of compliance with federal regulations and ISO standards.RESPONSIBILITIES:
·Assurance of compliance with FDA regulations, ISO standards, and customer specifications.
·Design, development, evaluation, validation, and transfer to manufacturing of new products and processes, and improvement of existing products and processes.
·Management of projects from initial concept through manufacturing startup to calculate development and production costs, create schedules and task assignments, produce specifications and documentation, interface with customers and vendors, and purchase manufacturing materials.
·Management of design history file and all associated deliveries.
·Provide engineering/technical support to Quality Control.
·Provide engineering/technical support to Manufacturing.
·Provide engineering/technical support to Customers.
·Provide quotations to new and existing customers for new products and
changes to existing products.
·Assist in setups and assembly of products.
·Assist in testing of products.
·Assist in machine design and build.
·Support product complaints analysis.
REQUIREMENTS
B.S. Degree in Math, Science, Engineering, or related field and the ability to design and develop products and processes, manage projects, and lead project teams.