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
Assembler III/IV:
- 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.
Lead Assembler:
- Train new technicians on assembly techniques, safety protocols, quality control, and equipment usage. Monitoring of their training and progress is required.
- Collaborate with Production Manager to align on build plan, identify inventory control issues, and identify assembly and test issues.
- 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 and analysis.
- Record process and product measurement data for quality control purposes, as required.
- Monitor equipment parameters and results of in-process inspection(s); as necessary, make adjustments according to documented procedures to ensure product meets appropriate quality specifications.
- Sign/date records to verify completion of procedures.
Experience Requirements:
Assembler III: A minimum of 3 years of medical device manufacturing or related experience.
Assembler IV/Lead: A minimum of 5 years of medical device manufacturing or related experience.
Education Requirements
- High school diploma or equivalent.
Other Qualifications:
Assembler III:
- 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.
Assembler IV:
- Able to assemble and test medical devices using gluing, laser welding, and heat fusing techniques.
- Able to assemble using microscopes and electrical test measurement equipment (multimeter).
- Able to hand-solder 30 AWG wire.
- Able to read and understand written instructions.
Lead Assembler:
- Able to assemble and test medical devices (catheters) using gluing, laser welding, and heat fusing techniques.
- Able to assemble using microscopes and use test measurement equipment.
- Able to read and understand written instructions.
Salary Range:
Assembler III: $30.00 - $39.10
Assembler IV: $34.58 - $45.68
Lead Assembler: $36.45 - $47.00
