Operator/ Machine Operator/ Assembler/ Cleanroom

Follow Quality Management Systems (QMS), Environmental Management Systems (EMS) , safety procedures, and regulatory requirements. Key Responsibilities: Perform assembly, repair, testing, and production operations on medical device components and assemblies.

Operator I Medical Device Manufacturing
Pleasanton, CA, 94588
Shift: 1st Shift | 5:00 AM 1:30 PMJob Summary:
We are seeking an Operator I to support the production of high-quality medical devices within a manufacturing cell. The position performs routine assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies while following established procedures and quality standards. Key Responsibilities:

• Perform assembly, repair, testing, and production operations on medical device components and assemblies.
• Follow written procedures, standardized work instructions, and verbal instructions.
• Maintain accurate production, traveler, and quality documentation to ensure full part traceability.
• Use electronic data collection systems and computer software for production activities.
• Inspect components and identify quality issues, defects, or process concerns.
• Follow Quality Management Systems (QMS), Environmental Management Systems (EMS), safety procedures, and regulatory requirements.
• Participate in Lean Manufacturing, continuous improvement, and quality initiatives.
• Support production goals related to quality, productivity, and profitability.
• Communicate production issues, ideas, and solutions effectively with supervisors and manufacturing management.
• Prioritize work based on job sequence, timing, and production requirements.
• Handle and maneuver small components and parts with precision.
• Maintain a clean, safe, and compliant manufacturing environment.
• Support manufacturing tours and interact professionally with internal and external customers.

Required Qualifications:

• High School Diploma or GED required.
• Ability to read, understand, and follow written procedures and verbal instructions.
• Basic understanding of Lean Manufacturing principles.
• Ability to use computers and electronic data collection systems.
• Strong attention to detail and documentation skills.
• Ability to handle small components and parts.
• Ability to prioritize tasks and make decisions with minimal supervision.
• Strong written and verbal communication skills.
• Ability to follow strict safety, quality, and gowning requirements.