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 as required.
- Complete required training and demonstrate the ability to consistently perform work according to established manufacturing procedures.
Required Skills / Qualifications:
- 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.
- Strong verbal and written communication skills.
- 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.
- High school diploma or GED required.
Preferred Qualifications:
- 1–2 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.
Sewing Experience Clarification:
- Prior sewing experience is preferred but is not required.
- Candidates with strong microscope experience, fine-motor dexterity, and the ability to learn precision medical-device sewing may be considered.
- Training on the specific sewing processes used in the role will be provided.
- This work differs from traditional machine or clothing sewing and involves precision work on medical-device and tissue components.
You should be proficient in:
- Fine Motor Skills & Manual Dexterity
- Medical Device Manufacturing
- Microscope Operation
- Precision Sewing & Assembly
- Hand-Eye Coordination