Position Summary:
Provide leadership for projects of key strategic significance to the company in the areas of R&D product launches, value improvement programs, product improvements and product transfers between facilities. Facilitate 24-hour support of existing manufacturing operations. Provide interface between R&D and manufacturing for the introduction of new products into manufacturing. Oversee creation, monitoring and control of project schedules and budgets such that company objectives are met. Manage assigned Manufacturing and Industrial Engineering department employees in accomplishing these activities.
Position Responsibilities:
Provide direction, both short and long term, to direct reports and other members of the Project Engineering department.
Act as a technical advisor, both inside this group and to the rest of the Company in the responsibility areas outlined.
While leading and conducting projects, apply knowledge and remain current in the following areas: materials, process and equipment development, procurement and optimization, injection molding, medical product and packaging design, design for manufacturing, design of experiments, product development process, design controls, device master record generation, process validations.
Participate in cross-functional teams led by manufacturing or R&D engineers.
Lead cross-functional teams for value improvement projects, product transfers, new products, and manufacturing support projects.
Assure appropriate validations are conducted.
Conduct design reviews as required.
Project team selection and management.
Provide timely resolution of product, process and equipment problems in the form of creative short and long term solutions.
Provide technical support to manufacturing operations.
Provide timely resolution of product, process and equipment problems in the form of creative short and long term solutions.
Provide technical support to manufacturing operations.
Stay current with and ensure appropriate QA/RA SOP’s are followed on all projects, including: regulatory submissions, product development process, design controls, biocompatibility and bio safety testing, process and product validations, and CO system.
Conduct failure analysis on QRGA’s
Required Skills
Knowledge of automation, plastic injection molding, plastics assembly methods, CAD, Solidworks and six sigma methodologies preferable.
Required Experience
Minimum of a four year degree in engineering or a relevant science.
Minimum of ten years progressive experience in an engineering capacity. Experience in a medical device, pharmaceutical, plastics or related industry preferred.
Must be experienced in project management with a successful history of project implementation.
Previous supervisory experience preferable.
AngioDynamics, Inc. - 10 months ago
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