The Sumter facility is a high-volume automated assembly and packaging operation for medical device products. This location makes many of the products used every day in hospitals, doctors offices, and other health organizations. This is an FDA regulated facility that utilizes GMP practices with a strong focus on safety and quality.
It offers and environment of continuous improvement and a constant pursuit of excellence. Additionally, the culture encourages professional development, teamwork and individual success, and daily challenges that will push you to be the best engineer you can be.
This position reports to the Engineering Supervisor. Responsible for the implementation of project and process support activities toward attainment of departmental and plant goals. Primary focus in areas of capacity expansion, quality/waste improvement and cost improvement programs. Required to handle multiple assignments of varying scope and complexity.
- Responsible for the design and implementation of machine improvements and capital equipment project management activities. Proficient in mechanical design and troubleshooting.
- Directs personnel in the troubleshooting and maintenance of cam driven mechanisms and pneumatic and hydraulic equipment used in the production process.
- Supports the plant manufacturing effort, with proven ability to identify problems and pursue plans toward their resolution. Specific focus will be in areas of improving upon chronic levels of quality, waste and equipment efficiencies.
- Has knowledge of proper Engineering practices and vendor relationships. Responsible for coordinating activities between equipment vendors, Division R & D and plant functional departments on his/her assignments.
- Ability to handle projects of a small to moderate scope. Will be required to handle several assignments (project & process duties) simultaneously.
- Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment.
- Establishes which elements comprising a job are suitable for in-house fabrication or revision and which items would be best contracted. Secure quotations and select contractors; direct the contractors efforts or the efforts of in-house forces to a satisfactory scheduled completion of the necessary work. Supervise and inspect all work in-process by contractors or plant forces; provide guidance where necessary.
- Responsible for the recommendation of capital equipment or process modifications, their physical installation, debugging and associated training of production personnel.
- As required within the scope of his/her duty, be responsible for all associated documentation, including; however not limited to, the following; validations, Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc.
- Accountable for spending (capital or expense) within approved limits on programs.
- Directs the efforts of support personnel such as machinists and technicians, etc. in the modification, adjustment, removal and installation of new or existing equipment as required.
- Bachelor degree in Mechanical Engineering.
- Minimum of 3 years of work experience in a manufacturing environment. Preferrably in the high-speed production of medical devices.
- Experience in the following areas:
- synchronous and asynchronous assembly platforms
- cam-operated equipment
- servo controlled assembly and AutoCad.
- Understanding of Lean Manufacturing initiatives with an emphasis in continuous improvement.
- Six Sigma certification (greenbelt or blackbelt) preferred.
Nationwide relocation provided