In this role, you will be in on the ground floor as we develop a strong operations team in a newly renovated production facility for a Class III combination device. The Assembler III performs a variety or repetitive and non-repetitive assembly operations in the catheter production of medical devices. Work is performed following established standards using diagrams, drawings or other assembly procedures.
Essential Functions:
Operates within standard operating procedures (SOPs) and assembly drawings
Cleans and maintains work area
Properly turns off and lock out equipment when not in use
Measures and records process parameters and report results to supervision
Adheres to production schedules and reports material shortages
Accurately documents all required entries in the Lot History Record
Complies with G.M.Ps with regard to material labeling, SOPs and proper segregation of material in the production process
Demonstrates an understanding of the SPNC Quality System
Ensures all training requirements are in a current status
Education and/or Experience:
Basic reading, writing and arithmetic skills required. This is normally acquired through a high school diploma or equivalent
Minimum of 2 years clean room production assembly experience
Certified to all stations and/or sequences within a major product family
Competencies:
Incumbent will be required to work in conditions normal for a manufacturing environment
Work involves standing for extended periods of time
Work involves frequent lifting of materials and product up to 30 pounds
Operations may require the use of safety equipment to include but not limited to: eye safety glasses, gowning, masks and hearing protectors
Good hand to hand and hand to eye coordination
Experience and ability to routinely use a microscope