Job Description

• To fabricate inserts, support set-up, inspect fixtures, and perform assemblies’ operations, following Cooper Vision Inc. procedures and policies.

• To prioritize work to maintain production in the manufacturing areas. Support Leader in priorities and schedules to achieve require delivery dates.

• The use of advanced metrology to ensure machined components are exceptionally high quality in surface finish, (sub-micro) and within critical (sub 10 microns) dimensional.

• Utilizing experience in advanced insert production to help develop more efficient methods of manufacture.

• Ensuring that the business schedules, production requirements and quality, cost and safety outcomes are always achieved.

• To carry out any duties the Inserts and workshop leader requires in aid of advancing the company, department or individual.

• Use and operate metrology and inspection equipment to obtain excellent quality results.

• Adhere to SOP’s and working instructions.

• Able to have effective communication with workshop leader, coordinator, and fellow insert makers.

• To be health and safely conscious.

To be flexible to best serve company’s needs.

1. Perform 100% inspection of work at the assigned manufacturing stage.

2. Receive new design specifications for inserts tooling, review the data sheet and load the relevant information onto manufacturing (batch control) system, so that the part being manufactured is allocated to a specific product and product cell and is individually traceable.

3. Fabricates inserts according to Cooper Vision quality systems, procedures, and policies - Sets up and operates Optoform machine: Assemble the material on the lathe, refer to the cutting program list, determine the cutting data, set the machine, and machine the required part, remove, clean, and inspect the surface using a radioscope to confirm that it matches the desired specification or adjust settings as required to ensure that the required specification is achieved.

4. Conduct radius and surface form metrology using interferometers and visual inspection equipment (shadowgraph) to micro accuracy.

5. For all new inserts enter the relevant data into the manufacturing data base to ensure that the accurate records of all activity are maintained.

6. To be accountable for inserts and sleeve quality before releasing the final part to production. Use the laser marking system to engrave parts and/or cavity identification information.

7. Ensure calibration of all equipment is up to date.

8. Perform or support repairs and refurbishment of equipment.

9. Execute maintenance of Optoform lathes.

10. Support movement of machinery.

11. Continuously look for areas of improvement within the working environment and communicate them to supervisors

12. Look to recycle and refurbish parts.

13. Participate in all training required within the role requirement/development.

14. To be able to make all inserts and plugs for all BU.

15. Attend and participate in company meeting when requested to do so.

16. Support development of documentation (ex. SOP/WI)

17. Reworks and repairs of parts (whenever applicable).

18. Reads mechanical drawings and blueprints.

19. Able to construct and/or modify parts following a mechanical drawing or blueprint.

20. Maintains insert shop equipment in optimal conditions.

21. Ensures the cleanness of the insert shop area.

22. Verifies dimension of parts and installation of components.

23. Follows LOTO procedures.

As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime. A willingness to be flexible with working hours to meet business needs when required.

• Graduated, one or more years of experience in medical devices/pharmaceutical industry with similar responsibilities.

• Setting and operation of the Optoform lathe.

• Manufacture inserts and plugs to within 0.250 Micron.

• Visual and measurements inspection

• Setting and operation of laser etcher

• Operation of laser radioscope

• Operation of radioscope and being able to decide on a visual image quality.

• Optoform validations

• Using precision measurements instrument such as micrometers, gauges and vernier calipers to check the part dimension.

• Using hand tool such as files and grinders

• Operation of shadowgraph

• Operating and interpreting results from the Fisba interferometer, to within 1 micron.

• Calibrating the interferometer, to within 1 micron

• Operating the EDM machine for the Toric scribe line process

• Setting and operation of the Optoform lathe and fast tool servo.

• Fitting, assembly, and pneumatic systems.

• Compiling reports.

• Strong communication Skills.

• Self-reliant, dependable, and able to use own initiative.

• Strong attention to detail.

Experience:

• Experiences of working in a high technology engineering company involved in the production of high-quality tooling.
• Computer literate, particularly Microsoft word, Excel, PowerPoint, and Outlook.
• Knowledge of FDA current GMP/QSR regulation.
• Able to execute responsibilities with minimum assistance and periodic supervision.
• Good written and oral communication skills.
• Ability to read and use micrometer, caliper, profile projectors, edge finders, height gage, toolmaker microscope, and others.
• Uses insert shop equipment produces inserts in specifications according to Cooper Vision procedures.

Education:

• Technical School Graduate or associate degree in Tool & Die Maker or equivalent experience.