Job Title: Operator I
Location: Irvine, CA 92614
Schedule: 5am - 1:30pm
Duration: 06+ months
Position Overview
- Responsible for producing high‑quality medical devices in a manufacturing cell
- Work performed under close supervision
- Tasks may include assembly, repair, and testing of:
- Pacemakers
- Implantable Cardioverter Defibrillators (ICDs)
- Leads and related medical device assemblies
- Perform routine assignments using standardized procedures
- Work is closely and continually reviewed
Key Responsibilities
- Follow all written and standardized manufacturing procedures
- Ensure job documentation is accurate and up to date
- Maintain accurate records for:
- Traveler documents
- Quality documentation
- Part traceability
- Communicate clearly (written and verbal) with all levels of manufacturing management
- Maintain a positive and professional attitude with internal teams and external visitors
- Follow all safety guidelines and use required safety equipment
- Participate in continuous improvement and quality initiatives
- Support Lean Manufacturing principles
- Assist in setting and monitoring:
- Individual goals
- Cell performance metrics
- Support Divisional initiatives, including:
- Quality Management Systems (QMS)
- Environmental Management Systems (EMS)
- Regulatory requirements
Required Skills & Abilities
- Ability to read, understand, and follow written procedures
- Ability to follow verbal instructions
- Basic understanding of Lean Manufacturing
- Ability to use:
- Electronic data collection systems
- Computer software applications
- Strong time management and prioritization skills
- Ability to sequence tasks based on importance and deadlines
- Ability to handle small components and parts
- Ability to make critical decisions with minimal supervision
Education Requirement
High School Diploma or equivalent required
Dress Code & Gowning Requirements (Interview & On‑the‑Job)
Clothing Guidelines
- Non‑shedding clothing; no frayed hems or loose threads
- No tassels, fringes, glitter, sequins, or loose fibers
- Sweaters, fleece, loose knit, or fiber‑shedding garments not allowed
- Clothing must be clean and free of contamination (lint, dirt, sand, etc.)
- All clothing must fit under lab coat/gown
- Sleeves and collars must not extend beyond gown
- Turtlenecks or high necks must not protrude above gown
Headwear
- No caps, hats, scarves, or bandanas under bouffant
- Cultural head wraps:
- Must be tightly woven
- Must be covered by bouffant and lab coat/gown
- Must be clean and laundered
Footwear Requirements
- Shoes must be always worn
- Socks or stockings required
- Heel height must be 2 inches or less
- No:
- Sandals
- Slippers
- Open‑toe or open‑heel shoes
- Shoes with visible toes
- No changing shoes in production area (except gowning room)
Personal Appearance & Safety
- Torsos, upper arms, and legs must be covered
- Not allowed:
- Sleeveless tops
- Short shirts (above navel)
- Pants or skirts above ankle
- Skirts with slits
- Skirts at ankle permitted only with leggings, stockings, or pants underneath
- No:
- Nail polish
- Acrylic or artificial nails
- Makeup
- Lip balm (stick form) allowed outside production area only
- No scented products (except deodorant)
- No lotion after hand washing
- Jewelry or piercings that cannot be covered or may pierce gloves are not allowed
- Cover all open or bleeding wounds with a bandage
- Do not wear anything offensive or inappropriate