Operators/Assembly-Medical Device-RWC or Santa Clara, Ca-Contract
Work in a clean room environment building multiple catheter products by following relevant Manufacturing Process Instruction (MPI). Follow a lean manufacturing process to achieve a daily build goal. Assist in building the next generation catheter products.
Core Job Responsibilities
- Build catheters to meet the company sales goals
- Meet catheter manufacturing yield and productivity goals
- Assist manufacturing/process/R&D engineers in resolving product and process problems
- Complete documentation such as Lot History Records per GMP requirements
- Support the introduction of new products onto the manufacturing line
- Follow GMP guidelines
Required Knowledge/Skills, Education, And Experience
- High school diploma
- Able to perform multiple assembly processes for complex design. Processes involves combination of multiple disciplines and skill sets.
- Able to handle and stuff multiple delicate components into shaft and assembly and glue small parts for integration.
- Train other operators
- Trouble shoot a failure
- Able to perform complicated test, which involves using computational equipment, device setup/ alignment, and understand test results.
- Support engineering group to resolve line issues and able to provide improvement ideas.
- Able to use common software for data collection or documentation such as MS excel and word.
- Redline MPI’s and LHR’s for accuracy
- Flexible and have multiple skill sets to be able to work in pilot lines to support new product development.
- Package product using pouch sealer and print labels using zebra printer.
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.
Position Type and Expected Hours of Work
This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 6:00am to 2:30pm or 2:30-11pm.
Please send resume to firstname.lastname@example.org