Operator I

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. Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable, and quality issues can be addressed.

<.>Operator I

Location: Irvine, CA
Duration: 12 Months
Pay Rate: $18.00 $19.00/hour
Shift: 5:00 AM 1:30 PM

Job Summary

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.

Key Responsibilities

• Ensure relevant job documentation for cell operations and functions is accurate and up to date.
• Clearly communicate ideas, problems, and solutions to all levels of manufacturing management in both written and oral form.
• Maintain a positive attitude when interacting with internal and external customers.
• Follow safety guidelines and utilize appropriate safety devices when performing all operations.
• Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality and profitability metrics.
• Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable, and quality issues can be addressed.
• Demonstrate a basic understanding of Lean Manufacturing.
• Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics.
• Support divisional initiatives and Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Required Qualifications

• Ability to read, comprehend, and follow written procedures.
• Ability to understand and follow verbal instructions.
• Ability to utilize electronic data collection systems and computer software packages.
• Ability to prioritize work based on precedence and importance.
• Ability to handle and maneuver small components and parts.
• Ability to make critical decisions and judgments with minimal supervision.
• High school diploma or equivalent required.

Production Area Dress & Safety Requirements

• Clothing must be non-shedding and free of frayed hems or loose threads.
• No tassels, fringes, glitter, sequins, or other items that could become dislodged.
• Sweaters, sweater vests, loose-fiber garments, loose-knit clothing, and fleece are not permitted.
• Clothing must be clean and free of visible contamination.
• Clothing must fit properly under the required lab coat/gown.
• Sleeves must not extend beyond the cuff of the lab coat/gown.
• Caps, hats, scarves, or bandanas must not be worn under the bouffant.
• Loose-fitting clothing is not permitted around machinery or soldering/brazing torches.
• Shoes must be worn at all times in the production area.
• Stockings or socks are required.
• Sandals, clogs, slippers, open-toe, or open-heel shoes are not permitted.
• Torsos, upper arms, and legs must be covered.
• Nail polish, acrylic, artificial nails, or similar nail coatings are not allowed.
• Jewelry or body piercings that cannot be covered under gowning materials are not allowed.
• Makeup is not permitted.
• Scented personal-use products are not permitted, except deodorant.
• Any open or bleeding wound must be covered with a bandage.
• Clothing and personal items must not create a safety concern or be offensive.