Sewing Machine Operator; Assembler

Position: Sewing Machine Operator (Assembler 2)
Assembler II - 1st Shift

Hours:

Monday - Thursday 5:30 AM - 4:00 PM, occasional OT Fridays

Status:
Full-Time

Reports to:

Assistant Supervisor

Position

Description:

Assembles basic medical devices in a controlled ISO 13485 environment, using documented procedures. Maintains high quality and throughput levels that support medical device finished goods manufacturing.

Position Authority:
This position has the authority to stop production at his/her work station if there is a question or concern about the acceptability of materials, assemblies, or processes that affect the quality or safety of Viant products. Freedom to act, under close supervision, in semi-structured assignments that normally require adherence to defined procedures and/or specific, detailed instructions with limited originality. Solves problems of limited scope and complexity.

Essential Job Functions:

Performs assembly and/or packaging operations per approved documentation and training.
Applies acquired knowledge of company's quality system to complete and review required documentation
Inspects product and paperwork for compliance to production and quality standards
Performs daily cleaning of workstation and work areas per quality systems requirements
Maintains high standards in quality, throughput, and attendance
Performs equipment set-ups and minor equipment troubleshooting
Assists in training other operators on procedures in which employee has received training
Identifies areas for process improvement, and makes recommendations to supervisors
Achieves acceptable level of proficiency on trained operations
Other duties as assigned by supervisor

Knowledge and

Education:

High school education or equivalent. Working knowledge of quality system requirements.

Job

Experience:

Must have completed training for assigned work area. 1+ year of experience is preferred; previous experience in a regulated environment is highly preferred.

Skills and

Competencies:

Possesses communication skills sufficient to read and write clearly and distinctly in English
Demonstrates understanding of the product and process flow for assigned work area
Qualified to operate equipment in assigned work area as necessary
Working knowledge of various production machines / equipment
Maintains a positive attitude with respect to changes in processes, methods, and work assignments
Detail- and quality-oriented
Once trained, able to work with little supervision
Performs basic arithmetic calculations. Handles multiple tasks simultaneously
Projects a positive example for others to follow in the workplace; demonstrates Viant Values

Equipment Used:

Solvent Dispenser
Solvents and Adhesives
Tube Stretcher
Small precision instruments
Tube cutter
EFD dispenser
UV Light cure
Arbor Press
Pneumatic Press
Go/No-Go Gauge
Bar / Tray Sealer
Stretch Wrapper
Pallet Jack
Air Gun
Heat Gun
Rivet Gun
Leak Tester
Automatic Bartacker
Single- and Double-Needle industrial sewing machines
Auto-labeler

Physical Requirements:

Light physical activity performing non-strenuous, day-to-day activities of a primarily productive nature.
Moderate lifting (20 lbs.), carrying (10 lbs.), bending, and prolonged sitting. Requires the ability to sit and stand for extended periods.
Manual dexterity sufficient to reach/handle items; work with fingers, hands, and arms; and perceive attributes of objects and material
Intensive, repetitive handwork for prolonged periods
Requires good eyesight with or without corrective lenses and the ability to identify and distinguish colors
Well-lighted, air-conditioned, indoor laboratory/production setting with adequate ventilation