General Assembler I

CooperCompanies•North Tonawanda, NY

3d•Onsite

About The Position

This position supports the assembly and production of medical devices in compliance with FDA, GMP, and ISO 13485 standards. The assembler ensures all components are built and documented according to company quality and safety requirements. Basic, repetitive assembly tasks under close supervision. Follow the product method sheet to understand the manufacturing process. Use hand tools, fixtures, or simple machinery as specified in the method sheet. Performs visual inspections for obvious defects. Requires minimal technical knowledge. Typically, it needs 0–2 years of experience.

Requirements

Basic understanding of manufacturing and assembly processes.
Strong manual dexterity and attention to detail.
Ability to read and follow written instructions and SOPs.
Good teamwork, communication, and problem-solving skills.
Basic computer and documentation skills.
Ability to work in a cleanroom environment and wear required PPE.
Consistent focus on quality and productivity.
Willingness to learn manufacturing processes and documentation.
Ability to work in a team environment.
Good communication and reliability.
High school diploma or equivalent required.

Nice To Haves

Knowledge of GMP and ISO 13485 standards
Medical device experience
Technical or vocational training in manufacturing

Responsibilities

Perform basic assembly operations following approved procedures, drawings, and SOPs.
Follow GMP, ISO 13485, and cleanroom standards to ensure product safety and compliance.
Maintain clean, organized, and safe work areas in accordance with company policies.
Operate hand tools, fixtures, and light equipment as required.
Communicate effectively with team members and supervisors to meet production goals.
Participate in training and continuous improvement activities.
Meets all production requirements and performance standards as defined by area Supervisor