Operator I – Medical Device Manufacturing/SS NEW

Irvine, California
Techlink Systems
Job Description Job Description

ob Summary – Operator I (2nd Shift)

Location: Irvine, CA (Onsite)
Contract Duration: Until 02/17/2027
Shift: 3:00 PM – 11:30 PM

Position Overview:
Seeking an Operator I to support the manufacturing of high-quality medical devices in a cleanroom environment. The role involves performing assembly, repair, testing, and documentation activities while maintaining strict compliance with FDA regulations and quality standards.

Key Responsibilities:

• Perform manual assembly, repair, and testing of medical devices such as catheters, pacemakers, ICDs, leads, and related components.
• Work under close supervision while following standardized manufacturing procedures.
• Maintain accurate production records and documentation for product traceability.
• Perform repetitive tasks including grasping, pinching, pulling, and twisting of small components.
• Operate tools and handle small parts under a microscope for extended periods.
• Follow cleanroom procedures, safety guidelines, and quality requirements.
• Communicate issues, solutions, and updates effectively with team members.

Required Skills & Experience:

• Medical device manufacturing or cleanroom experience preferred.
• Experience with manual assembly of small components.
• Comfortable working under a microscope for long periods.
• Experience with hand soldering or precision tools is a plus.
• Ability to read and follow written procedures and verbal instructions.
• Strong attention to detail and ability to maintain quality standards.
• Ability to sit and stand for extended periods while performing repetitive tasks.

Work Environment Requirements:

• Must comply with strict cleanroom gowning and dress code requirements.
• No jewelry, makeup, artificial nails, nail polish, or scented products allowed in production areas.
• Must wear appropriate closed-toe footwear and clean, non-shedding clothing.
• Must be comfortable working in an FDA-regulated manufacturing environment.

Company Description TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. Company Description TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.