Production Operator

Job Description

Job Description

Department: Production

Reports To: Department Supervisor

Summary/Purpose:

Under general supervision the employee will mold, assemble and package various medical devices and other products.

Essential Functions:

1. Prepare and mix materials according to manufacturing procedures.

2. Set up equipment per procedure.

3. Prepare, and maintain molds.

4. Apply material to mold and cure.

5. Mold using injection molding machine.

6. Trim flash on molded parts

7. Produce product using laminating equipment

8. Clean and package product for sterilization or end user

9. Manufacture OEM products using outside designed processes

10. Work with complex equipment to fabricate component material.

11. Enter data into computer for product identification and traceability

12. Box product for end user.

13. Work in a harmonious manner with others in the company and throughout the organization

14. Work on special projects as assigned.

15. Complete lot traceability paper work.

16. Read, understand and follow procedures.

17. Ability to work independently to perform daily operating tasks.

18. Maintain workplace in a clean, safe and orderly manner.

19. Required to be present in the work place during scheduled work hours.

20. Perform required secondary operations.

Marginal Functions:

Participate in other work functions as directed.

Physical Demands:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job the employee will:

• Regularly be required to stand, walk and use hands to touch with fingers, handle or feel.

• Frequently be required to reach with hands or arms, and talk and hear.

• Frequently use either one or both hands to firmly grasp, push and/or pull.

• Occasionally reach overhead to grasp objects.

• Lift or carry up to 40 pounds.

• Be around equipment and machinery and work in a Clean room environment.

• Normal 20/20 vision ability (with corrective lenses, if needed) is required.

Qualifications and Requirements:

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required.

Education:

None Required

Skills:

1. Manual dexterity required.

2. Read, understand and accurately complete documentation in English.

3. Effectively communicate in English, information in one-on-one situations to other employees of the organization.

4. Function in a controlled environment regulated by FDA cGMPs.

5. Be flexible in changing daily workload priorities as directed.

6. Maintain accuracy, consistency and quality in a fast paced, multi-task environment.

7. Accurately perform detail oriented work.

8. Add, subtract, multiply, and divide and ability to perform these operations using units of American and metric

measurement.

Experience:

No prior experience or training. May train on job.

Training:

Training requirements for this position are called out in the Required Employee Training Matrix.