Associate Sewer / Precision Assembly Associate

Job Title: Associate Sewer

Job Type: Full-Time
Shift: Second Shift (2:45 PM 11:15 PM)

Education: High School Diploma or GED

Job Summary:
The Associate Sewer is responsible for performing precision sewing and assembly of tissue and non-tissue components used in medical device manufacturing. This role requires excellent fine motor skills, hand-eye coordination, attention to detail, and the ability to perform intricate tasks under a microscope for extended periods.

The Associate Sewer works in a cleanroom manufacturing environment and follows established work instructions, Good Manufacturing Practices (GMP), quality standards, safety requirements, and documentation procedures to ensure product quality and compliance.

Key Responsibilities:

• Perform precision sewing and assembly of medical device components, including biological and tissue materials, using needles, scissors, forceps, microscopes, and specialized tools.
• Perform detailed, repetitive tasks under a microscope while maintaining accuracy, consistency, and productivity.
• Follow standard operating procedures (SOPs), written work instructions, manufacturing specifications, and quality requirements.
• Conduct inspections and quality checks on completed components and perform verification checks on work completed by team members.
• Accurately complete device history records (DHRs) and other required manufacturing documentation.
• Maintain compliance with cleanroom requirements, Good Manufacturing Practices (GMP), safety procedures, and environmental standards.
• Maintain a clean, organized, and orderly work area.
• Complete required training and demonstrate proficiency in assigned manufacturing processes.
• Collaborate with team members and supervisors to meet production and quality objectives.
• Follow established procedures for handling materials, tools, and medical device components.

Required Qualifications:

• High school diploma or GED.
• Strong fine motor skills, manual dexterity, and hand-eye coordination.
• Excellent attention to detail and the ability to perform precise, repetitive tasks.
• Ability and willingness to work under a microscope for extended periods.
• Ability to read, understand, and follow written instructions and manufacturing procedures in English.
• Ability to work in a cleanroom environment and comply with gowning requirements and cleanroom restrictions.
• Ability to work independently with limited supervision and contribute effectively to a team.
• Commitment to quality, safety, accuracy, and compliance with manufacturing procedures.

Preferred Qualifications:

• 0 2 years of experience in manufacturing, production, assembly, or a related field.
• Previous experience in precision sewing, hand sewing, or detailed assembly.
• Experience using microscopes for inspection, assembly, or laboratory work.
• Experience in medical device manufacturing, cleanroom operations, or GMP-regulated environments.
• Experience handling delicate materials or performing intricate manual tasks.

Sewing Experience:
Previous sewing experience is preferred but not required. Candidates with strong manual dexterity, microscope experience, attention to detail, and the ability to learn precision assembly techniques are encouraged to apply. Training will be provided on the specific sewing processes used in medical device manufacturing.

This role involves specialized precision sewing of medical device and tissue components and differs from traditional garment or machine sewing.

Work Environment and Schedule:

• Full-time position in a cleanroom manufacturing environment.
• Second shift: 2:45 PM 11:15 PM.
• Requires extended periods of microscope-based work and repetitive fine-motor activities.
• Requires adherence to cleanroom gowning, safety, quality, and documentation procedures.