Manufacturing ​/ Production Operator, Manufacturing Production

Job Title: Operator I

Location: Irvine, CA 92614

Schedule: 5am - 1:30pm

Duration: 06+ months

• 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

• 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

• 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

High School Diploma or equivalent required

• 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

• 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

• 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)

• 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