Cleanroom, Clothes Making, Continuous Improvement, Detail Oriented, Hand Tools, Maintain Compliance, Manufacturing, Manufacturing Requirements, Microscopic Analysis, Procedure Development, Production Support, Quality Management, Quality Metrics, Regulatory Compliance, Regulatory Requirements, Requirements Management, Test & Measurement Equipment, Test Design, Test Fixtures, Validation Testing
Title: Tissue Specialist I
Location: Plymouth, MN
Hours: Mon - Thur | 3:30 PM - 2:00 AMDescription:
This role is responsible for the precise assembly of sewn structural heart devices in a cleanroom manufacturing environment. The position requires exceptional attention to detail and the ability to perform fine sewing tasks using a microscope.
Key Responsibilities
- Assemble sewn structural heart devices in accordance with approved manufacturing procedures
- Perform precision sewing using suture and needle under a microscope
- Utilize small hand tools, calibrated instruments, measuring equipment, microscopes, and test fixtures
- Ensure all materials used in device manufacturing meet design specifications and quality standards
- Support activities related to design, testing, verification, and validation for both new and existing products
- Follow established procedures and maintain compliance with quality and regulatory requirements
- Collaborate with team members to support production goals and continuous improvement efforts
Required Skills & Qualifications
- Ability to perform extremely detailed, precision-oriented work
- Experience working in a cleanroom environment (preferred)
- Strong fine motor skills and hand-eye coordination
- Ability to sew using suture and needle, ideally under magnification
- Comfortable using microscopes for extended periods
- Familiarity with small tools and measurement equipment
Education
- High School Diploma or GED preferred (or equivalent experience)
Work Environment
- Cleanroom setting requiring strict adherence to contamination control practices
- Repetitive fine motor tasks and extended periods of focused, detailed work
A
Axelon Services Corporation