This position provides senior-level manufacturing engineering support to a manufacturing operation. This may include implementing new manufacturing processes, improving existing manufacturing processes, repairing and coordinating the repair of production machinery, and providing technical guidance to manufacturing personnel.
Provide resources for product design and manufacturing processes for cost and cycle time reduction. Participate in budget discussions, cost savings strategies and planning, as well as project management oversight.
Lead and manage activities for CIPs/Maintenance of Business. Investigate, justify and implement automation and new technology opportunities. Provide make or buy rationale for components. Suggest product redesigns to reduce cost and cycle. Improve production processes, equipment and methods to reduce cost and cycle.
Manage the design transfer from the prototype stage to full production. Provide assistance with CAD documentation, SOP’s, Test Instructions, PFMEA. Manage the document package for the approval process. See that necessary validations or verifications are performed according to Quality Systems Regulations.
Work with the Operations, D+R and Quality departments to meet FDA Quality System Regulations. Manage the change control process for projects.
Scope of Position:
This position will be responsible for managing cross functional teams for projects through timely completion of the project and sustained effectiveness post launch.
This position will be responsible for managing the budget for these projects.
Manufacturing, D&R and Site and Global Quality.
This position will provide status reports to upper management on the projects they are managing.
Bachelor’s Degree in Engineering.
Master's Degree in Engineering.
Five or more years or progressively responsible manufacturing engineering experience. Ability to functional effectively independently and with other functions within the organization. Project management experience.
Medical device industry experience
Previous supervision experience
Project Management in manufacturing engineering. Data analysis, problem solving and communication skills.
Strong mechanical or electrical aptitude.
Six Sigma Green Belt or Black Belt, Project Management Certification