Assembler III

SUMMARY

Assemblers are primarily responsible for assembling and testing catheter-type medical devices according to documented manufacturing procedures. The devices are assembled using various manual UV bonding, heat fusing, and hand-soldering techniques. The devices are assembled using Good Manufacturing Practices (performing line clearance, following written procedures, completing manufacturing records) and Good Documentation Practices.

The assembly work scope covers both Commercial and Pilot life cycles. Therefore, the assemblers are expected to be flexible across process stations and product lines. Additionally, assemblers are expected to learn quickly, offer feedback for process improvements. Assemblers shall comply with documented company policies and procedures, including quality, safety, and environmental policies.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Clean workstations and perform line clearance per documented procedures.
• Setup equipment and obtain materials as required by the manufacturing record.
• Build subassemblies and/or final assemblies per manufacturing procedures.
• Perform in-process inspections of components/materials, subassemblies, and final assemblies to ensure that specifications are met and/or for data collection.
• Record process and measurement data for quality control purposes, as required.
• Monitor equipment parameters and results of in-process inspection(s).
• Sign/date records to verify completion of procedures.
• Assists supervisor and/or lead with inventory management.

EXPERIENCE REQUIREMENTS

• A minimum of 3 years of medical device manufacturing or related experience.

EDUCATION REQUIREMENTS

• High school diploma or equivalent.

OTHER QUALIFICATIONS

• Able to assemble medical devices using adhesives, soldering iron, and hot box.
• Able to assemble devices while using a microscope.
• Able to read and understand written instructions.