Manufacturing Assembler (LB2026)

Job Title: Operator I - 2nd Shift
Location: Irvine, CA (onsite)
Work Hours: 3pm - 11:30pm

Job Description
This is a non-exempt position. This position is responsible for the production of high quality medical devices within a cleanroom environment.

• Working under close supervision, may perform a combination of assembly, repair, and test operations on medical Catheters.
• Maintain Compliance and Quality while performing routine assignments according to standardized procedures.
• Be able to clearly communicate ideas, problems and solutions.
• Maintain a positive attitude when interacting with internal customers and external customers.
• Follow safety guidelines while onsite.
• As an FDA regulated company, maintaining accurate documentation ensures all parts are traceable and quality issues can be addressed.
• Have the ability to read, comprehend, and follow written procedures; understand and follow verbal instructions.
• Ability to handle and maneuver small components and parts under microscope.
• Ability to seat and stand for long periods of time.
• Able to perform repeated tasks such as grab, pinch, pull, twist.
• Sought after experience:
• • Manual Assembling of medical devices.
  • Assemble and use tools under the microscope for long periods of time.
  • Hand soldering.
  • Cleanroom environment.
  • Maintain written and electronic documentation.

This position is responsible for the production of high quality medical devices within a manufacturing cell.

• Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies.
• Performs routine assignments according to specified and/or standardized procedures.
• Work is closely and continually reviewed.
• Required dress code for tour during interview and on-the job: Clothing must be non-shedding and free of frayed hems or loose threads.
• Tassels, fringes, glitter, sequins (sewn or glued on), and any other items that could become dislodged are not allowed on clothing.
• To verify a fabric can be worn: pull at the fabric tightly with fingers, if fibers are dislodged, the garment may not be worn in the production area.
• Sweaters, sweater vests, loose fiber garments, loose knit, or fleece may not be worn.
• All clothing must be clean and free of visible contamination (sand, mud, dirt, lint, etc.).
• All clothing, from the waist up, must fit under the lab coat/gown.
• Turtle necks or high-necked clothing shall not stick out above the neck of the lab coat/gown.
• Sleeves shall not stick out beyond the cuff of the lab coat/gown.
• Caps, hats, scarves or bandanas shall not be worn under the bouffant.
• Head wraps/scarves worn to accommodate customs: Must be covered with the bouffant and the tail end of the scarf must be fully covered by the lab coat/gown.
• Must be of tightly woven fabric, be clean, and laundered.
• Loose fitting clothing shall not be worn around machinery or soldering/brazing torches.
• Shoes must be worn at all times in the production area. Stockings or socks are required.
• The heel of a shoe must not be pointed or higher than 2 inches.
• Sandals, clogs, slippers, open toe, or open heel shoes are not allowed.
• Shoes with straps or weave where toes can be seen are not allowed.
• Changing shoes in the production area, other than a gowning room, is not allowed.
• Torsos, upper arms, and legs must be covered.
• Pants (above the ankle), skirts (above the ankle), skirts with slits, short shirts (above the navel), and sleeveless tops are not allowed.
• Skirts at the ankle are allowed, but full-length stockings, leggings, or pants must be worn under them.
• Nail polish, acrylic, artificial nails, or similar nail coatings are not allowed.
• Jewelry or body piercings that can pierce gloves or cannot be covered under gowning materials will not be allowed in the production area.
• Makeup shall not be worn.
• Lip balm in stick form is acceptable, when applied outside of production areas and prior to hand washing.
• Scented personal use products shall not be worn, except deodorant.
• Lotions shall not be applied after hand washing.
• Cover any open or bleeding wound with a bandage.
• Don't wear anything that could be offensive.