Production Assembler

The Production Assembler contributes to the assembly of ventilators, which includes packaging and final labeling, in our regulated FDA-compliant manufacturing facility. This team member needs to be detail-oriented, skilled in fine assembly work, and able to follow instructions meticulously. This role requires adaptability, a strong work ethic, being on-time each workday, and a commitment to maintaining the highest standards of quality and compliance. 

Key Responsibilities: 

• Perform fine assembly tasks with precision, including handling small parts and components. 

• Perform final packaging and labeling processes per established work instructions. 

• Follow detailed instructions, standard operating procedures (SOPs), and work orders to assemble ventilator units. 

• Ensure compliance with FDA regulations and internal quality standards throughout the assembly process. 

• Perform quality checks and inspections to ensure all products meet exact specifications. 

• Maintain a clean, organized, and safe work environment in compliance with Lean 5S and safety standards. 

• Adapt to changes in production schedules, priorities, and processes as needed. 

• Communicate effectively with team members and supervisors to ensure production goals are met. 

• Document work activities accurately and promptly as required. 

Qualifications: 

• Education: High School Diploma or GED required. 

• Experience: Previous experience in a regulated medical device or FDA-compliant manufacturing environment is a preferred but not required. 

• Strong attention to detail and ability to work with small components. 

• Manual dexterity and comfort with repetitive tasks in a production environment. 

• Ability to follow written and verbal instructions precisely and consistently. 

• Strong organizational skills and the ability to adapt to process changes. 

• Excellent communication and teamwork skills. 

Preferred Qualifications: 

• Prior experience in medical device assembly or other highly regulated industries. 

• Familiarity with quality management systems (QMS) and FDA regulations. 

• Basic understanding of safety and gowning protocols. 

• • Process Improvement: 

• • • Identify and implement process improvements to enhance efficiency, accuracy, and safety in manufacturing/assembly, material handling, packaging, and labeling operations. 

• • • Collaborate with the engineering, quality and supply chain teams to resolve any issues related to manufacturing/assembly, packaging, labeling, or inventory control. 

Physical Requirements 

• Ability to sit, stand, and perform repetitive motions for extended periods. 

• Comfortable working with tools and small parts in a controlled environment. 

• Ability to occasionally lift up to 35 lbs. 

This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.