Role: Operator I
Location: Irvine, CAJob Summary:The Operator I role is responsible for supporting the production of high-quality medical devices in a manufacturing environment. Under close supervision, candidates will perform assembly, repair, and testing operations on pacemakers, ICDs, leads, and related medical device components while following standardized procedures and quality guidelines.
Key Responsibilities:- Assemble, repair, and test medical device components
- Follow detailed written and verbal work instructions
- Maintain accurate production and quality records
- Support Lean Manufacturing and continuous improvement initiatives
- Ensure compliance with Quality Management Systems (QMS) and safety procedures
- Communicate effectively with supervisors and team members
- Handle small components with precision and attention to detail
- Utilize electronic data collection systems and computer software
Required Qualifications- High school diploma or equivalent
- Ability to read, understand, and follow procedures and instructions
- Basic computer skills and electronic documentation experience
- Strong attention to detail and ability to work in a regulated manufacturing environment
- Ability to prioritize tasks and work with minimal supervision
- Good manual dexterity for handling small parts/components
Work Environment- Medical device manufacturing environment with strict cleanroom/gowning requirements
- Candidates must follow detailed dress code, hygiene, and contamination-control standards
- PPE and production-area compliance required at all times
Preferred Skills- Medical device manufacturing experience
- Assembly or production line experience
- Knowledge of Lean Manufacturing principles
- Experience in regulated environments (FDA/GMP)