Medical Device Assembler - 2nd shift (CM2025)

Job Description

Job Description

Job Title: Operator I - 2nd Shift
Location (On-site, Remote, or Hybrid?): Irvine, CA (Onsite)
Contract Duration: Contract until 03/05/2027
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.

1. Working under close supervision, may perform a combination of assembly, repair, and test operations on medical Catheters.
2. Maintain Compliance and Quality while performing routine assignments according to standardized procedures.
3. Be able to clearly communicate ideas, problems and solutions.
4. Maintain a positive attitude when interacting with internal customers and external customers.
5. Follow safety guidelines while onsite.
6. As an FDA regulated company, maintaining accurate documentation ensures all parts are traceable and quality issues can be addressed.
7. Have the ability to read, comprehend, and follow written procedures; understand and follow verbal instructions.
8. Ability to handle and maneuver small components and parts under microscope.
9. Ability to seat and stand for long periods of time.
10. Able to perform repeated tasks such as grab, pinch, pull, twist.
11. Sought after experience:
12. 1. Manual Assembling of medical devices.
    2. Assemble and use tools under the microscope for long periods of time.
    3. Hand soldering.
    4. Cleanroom environment.
    5. 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.​​​​​​​