Summary
Assemblers are primarily responsible for assembling and testing catheter-style medical devices according to documented manufacturing procedures. The catheters are assembled using various manual UV bonding, heat fusing, and hand-soldering techniques. The catheters are assembled using Good Manufacturing Practices (performing line clearance, following written procedures, completing manufacturing records) and Good Documentation Practices.
Lead Assemblers will need to be able to learn quickly, offer feedback for process improvements, and be able to flex between multiple process stations. Lead Assemblers must also comply with documented company policies and procedures, including quality, safety, and environmental policies. Lead Assembler is also expected to guide and organize other team members to achieve department goals.
PRINCIPAL DUTIES AND RESPONSIBILITIES
- 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
- A minimum of 5 years of medical device manufacturing or related experience.
EDUCATION REQUIREMENTS
- High school diploma or equivalent.
- 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.
OTHER QUALIFICATIONS
- 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.
