Operator I

Job Title: Operator I
Location: Pleasanton, CA
Duration: 12 Months
Pay Rate: $20.50 $21.50/hour (W2)
Shift: 5:00 AM 1:30 PM

Position Summary
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Under close supervision, the Operator I performs a combination of assembly, repair, and testing operations on medical device assemblies and related components.
The role requires performing routine manufacturing assignments according to established procedures and maintaining accurate production documentation. Work is reviewed regularly to ensure compliance with quality standards, regulatory requirements, and company procedures.
The operator must be able to communicate ideas, problems, and solutions clearly with manufacturing teams and management through both written and verbal communication. The position requires maintaining a positive attitude when interacting with internal teams and external visitors.
Key Responsibilities

• Perform assembly, repair, and testing operations on medical device components following approved procedures.
• Ensure all production documentation, records, and quality documents are accurate and up to date.
• Maintain product traceability and support resolution of quality issues.
• Follow safety guidelines and properly use required safety equipment.
• Participate in continuous improvement and quality initiatives to improve production processes, efficiency, and product quality.
• Support Lean Manufacturing initiatives and process improvement activities.
• Work with supervisors and managers to establish and monitor individual goals and cell performance metrics.
• Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Maintain accurate electronic and written production records.
• Prioritize tasks based on production schedules, job importance, and workflow requirements.

Required Skills & Qualifications

• Ability to read, understand, and follow written procedures and verbal instructions.
• Ability to use electronic data collection systems and basic computer software applications.
• Ability to handle and maneuver small components and parts with precision.
• Ability to make decisions and judgments with minimal supervision.
• Basic understanding of Lean Manufacturing principles.
• High school diploma or equivalent required.

Production Area Dress Requirements
Employees must follow strict clean manufacturing area requirements:

• Clothing must be clean, non-shedding, and free of loose threads, frayed hems, glitter, sequins, tassels, or materials that may create contamination.
• Sweaters, fleece, loose-knit garments, and loose-fiber clothing are not permitted.
• All clothing must fit completely under required lab coats/gowns.
• Sleeves, scarves, and other items must not extend beyond gowning requirements.
• Head coverings must comply with gowning procedures.
• Clothing must be free from visible contamination such as dirt, lint, sand, or debris.
• Shoes must be worn at all times in production areas.
• Socks or stockings are required.
• Open-toe, open-heel shoes, sandals, slippers, clogs, or shoes that expose toes are not allowed.
• Shoes must have a heel no higher than 2 inches and may not have pointed heels.
• Changing shoes is only permitted in designated gowning areas.
• Arms, legs, and torso must remain covered.
• Shorts, sleeveless tops, short shirts above the navel, and inappropriate clothing are not permitted.
• Skirts must meet production area requirements and require appropriate coverage underneath.
• Nail polish, artificial nails, acrylic nails, and similar nail coatings are not allowed.
• Jewelry or body piercings that may damage gloves or cannot be covered by gowning materials are prohibited.
• Makeup is not permitted in production areas.
• Only approved personal care products may be used.
• Open wounds must be properly covered with a bandage before entering the production area.
• Clothing and personal items must comply with safety and contamination control requirements.