Job Description

Operator I

Location: Pleasanton, CA Role Overview:
Entry-level manufacturing role focused on assembling, testing, and repairing high-quality medical devices (e.g., pacemakers, ICDs) in a controlled production environment, following strict quality and regulatory standards. Key Responsibilities

• Perform assembly, repair, and testing of small medical device components
• Follow standard operating procedures (SOPs) under close supervision
• Maintain accurate documentation and ensure traceability
• Use tools like tweezers, epoxy dispensers, calipers, microscopes
• Ensure compliance with GMP, QMS, and safety standards
• Support quality initiatives and continuous improvement (Lean Manufacturing)
• Communicate effectively with team and supervisors

Requirements

• High School Diploma or equivalent
• 6 months 2 years of relevant experience
• Soldering experience preferred
• Familiarity with GMP, IPC standards, and documentation practices

Key Skills

• Strong attention to detail (small component handling)
• Basic computer and data entry skills
• Ability to follow instructions and prioritize tasks
• Good communication and teamwork skills
• Ability to work in a cleanroom-like, regulated environment

Additional Notes

• Strict cleanroom dress code and hygiene standards
• Requires manual dexterity and handling of delicate parts
• Work is closely supervised and quality-driven

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