Heart Valve Sewer

About the Role

This long-term temporary (12-18 months) position involves detailed, precision sewing and assembly of tissue and non-tissue components for medical devices. The role requires strong hand-eye coordination, fine motor skills, patience, and the ability to perform highly detailed work using a microscope for extended periods in a cleanroom manufacturing environment. Adherence to established procedures, quality standards, safety requirements, and documentation practices is essential.

Key Responsibilities

• Perform precision sewing and assembly of medical-device components, including biological/tissue materials, using needles, scissors, forceps, microscopes, and other specialized tools.
• Perform detailed work under a microscope for extended periods while maintaining accuracy and consistency.
• Follow written work instructions, procedures, specifications, and quality requirements.
• Perform required inspections and verifications of completed work and successive checks on work completed by team members.
• Accurately document required information within device history records and other production documentation.
• Maintain established cleanroom, GMP, safety, and environmental requirements.
• Maintain an organized work area and perform general housekeeping duties.
• Complete required training and demonstrate the ability to consistently perform work according to established manufacturing procedures.

Requirements & Tech Stack

• Strong fine-motor skills and hand-eye coordination.
• Ability to perform precise, repetitive work requiring patience and sustained attention to detail.
• Ability and willingness to work extensively with a microscope.
• Ability to read, understand, and follow written procedures and manufacturing instructions in English.
• Ability to work effectively in a cleanroom environment and comply with applicable cleanroom restrictions and gowning requirements.
• Ability to work effectively in a team environment with limited supervision.

Qualifications

• High school diploma or GED required.
• 0-2 years of related manufacturing or production experience preferred.
• Previous experience with sewing, precision assembly, microscope-based work, cleanroom manufacturing, GMP environments, medical-device manufacturing, laboratory work, or similar detailed production work is preferred.

Note: Prior sewing experience is preferred but not required. Training on specific medical-device sewing processes will be provided.