Assembler I (Medical Device/GMP)

Job Summary

We are seeking a detail-oriented Assembler to assemble and package medical devices in cleanroom and non-cleanroom manufacturing environments. The ideal candidate will have strong manual dexterity, attention to detail, and the ability to follow manufacturing procedures, quality standards, and safety requirements.

Responsibilities

• Assemble and package medical devices according to specifications, procedures, and GMP requirements.
• Perform visual and in-process quality inspections of devices and packaging materials.
• Conduct required testing, including airflow testing, as applicable.
• Accurately document manufacturing activities, data, and results in accordance with GDP requirements.
• Follow cleanroom gowning, sanitation, PPE, safety, and manufacturing procedures.
• Handle small components and tools with precision to prevent defects, damage, and scrap.
• Maintain clean and organized work areas, equipment, tools, and supplies.
• Identify and immediately report product defects, process issues, and deviations.
• Rotate between manufacturing operations and assigned training modules as required.
• Work effectively with team members, leads, and supervisors.
• Work scheduled hours and overtime as required.

Requirements

• High School Diploma, GED, or equivalent.
• Ability to read, understand, and follow manufacturing procedures and work instructions.
• Strong manual dexterity, hand-eye coordination, and attention to detail.
• Ability to meet 20/20 corrected visual acuity requirements and pass required testing/certification.
• Ability to work on-site, follow GMP/GDP, PPE, quality, and safety requirements.

Preferred Qualifications

• Previous experience in medical device, pharmaceutical, manufacturing, assembly, or cleanroom environments.

Physical & Work Environment

• Frequent use of hands, fingers, and wrists for precision and repetitive assembly tasks.
• Requires close visual inspection of small parts and defects.
• Ability to handle components and materials weighing up to approximately 10 lbs.
• Must be comfortable working in a cleanroom environment and wearing required PPE, including gowns, gloves, eye protection, face protection, and shoe coverings.
• May be exposed to manufacturing equipment, noise, moving machinery, electrical hazards, heat, and/or chemicals depending on the work area.