This position is responsible for sewing and assembling small medical devices in accordance with the manufacturing schedule, inspecting components and finished product, maintaining accurate records, and managing the cleanroom environment.
- Sew and assemble very small medical devices to specification in a cleanroom environment.
- Read detailed manufacturing instructions and drawings.
- Inspect materials and components, in-process assemblies, and finished goods.
- Assist with inventory and cycle counts.
- Maintain production and inspection records.
- Assist with monitoring and testing cleanroom environment.
- Small assembly tools
- Measurement instruments such as micrometers, calipers, gages
- Two-year degree (or appropriate work experience) preferred
- High School equivalent
- 5 years of manufacturing experience (medical device preferred)
- Work in a cleanroom environment preferred
- Work in a regulated environment (FDA or ISO 13485)
Knowledge, Skills & Abilities
- Excellent sewing technique.
- Ability to sew and assemble very small medical devices.
- Ability to manipulate small parts and work under a microscope.
- Manual dexterity and good visual acuity.
- Knowledge of measurement instruments.
- Communicate in English (verbal and written).
- Working knowledge of cleanroom operations.
- Working knowledge of manufacturing methods such as finishing, cleaning and packaging.
- Familiarity with Microsoft Office tools.
- Ability to lift and carry 30 lbs.
- Ability to work in a cleanroom and follow gowning requirements.