Operator 1, Other Production

Katalyst CRO; Irvine (CA); On-site; USD 42,000 - 64,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Technician to perform assembly, testing, and maintenance of medical devices on production lines in Irvine, CA. The role emphasizes adherence to safety policies, GMPs, and fast, accurate execution on multiple lines.

You will work with hand and small power tools, calibrate parts, and support R&D builds while maintaining a clean, compliant production area and a collaborative team environment.

Qualifications

• High school diploma or equivalent preferred.
• Experience level may vary by role level.
• Familiar with standard concepts, practices, and procedures.

Responsibilities

• Follow safety policies and procedures.
• Work on assembly lines including cartridge filling, applicator assembly and packaging operations.
• Follow GMPs and manufacturing procedures.
• Assemble units using hand tools and small power tools.
• Test and calibrate parts to meet tolerances and specifications.
• Assist manufacturing engineering with equipment maintenance.
• Support R&D builds.
• Maintain organization of production area.
• Ensure a safe work environment.
• Support FDA/ISO/CMDR compliance requirements.
• Perform inspections, tests, and operations to ensure quality.
• Clean production area (cleanroom and packaging) as described in cleaning schedule.
• Perform other duties as assigned.

Skills

Communication skills

Reading & interpreting specs

Measurement tools

Teamwork

Flexibility / overtime

Safety awareness

Education

High school diploma or equivalent

Tools

Microscopes

Hand tools

Small power tools

Job description

Job Description

Performs any combination of tasks involved in the manufacture and assembly of medical devices as well as setting up, operating, performing maintenance on and troubleshooting equipment.

Responsibilities

• Responsible for following safety policies and procedures.
• Work on various assembly lines including but not limited to: cartridge filling, applicator assembly and packaging operations.
• Responsible for following all required GMP's and applicable manufacturing procedures.
• Builds product per production schedules using hand tools and small power tools to assemble units.
• Tests and calibrates parts and mechanisms to meet tolerances and product specifications.
• Assists manufacturing engineering with equipment maintenance.
• Supports R&D builds.
• Maintains organization of production area.
• Ensures that a safe work environment is maintained.
• Supports requirements necessary to establish and maintain FDA, ISO and CMDR compliance.
• Performs a variety of inspections, tests, and operations as required, to ensure the quality of manufactured product while adhering to company procedures.
• Performs production area (Cleanroom and packaging) cleaning as described in pertinent cleaning schedule.
• Performs special projects and other duties as assigned.

Requirements

• High school diploma or equivalent Preferred.
• Level I: Six (3) months to three (3) years experience in a directly related field.
• Level II: Three (3) to five (5) years experience in a directly related field.
• Level III: Five (5) or more years experience in a directly related field.
• Familiar with standard concepts, practices, and procedures within the field.
• Effective communication skills at a level co-workers and Team Lead/Supervisor can understand.
• Ability to read, write, interpret and comprehend specifications written in English and perform basic math calculations.
• Ability to use basic tools of measurement, such as microscopes.
• Must be able to work flexible and/or extended hours and report to work on a regular, punctual basis.
• Ability to get along with people and be able to work in a team environment.
• Willingness to rotate into different tasks and responsibilities.

Work Environment / Demands Of The Position

Travel No travel is expected with this position.

Physical Demand

While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Occasionally the employee may be required to lift or move at least 50 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mental Demand

Moderate to high degree of concentration due to volume, complexity, and/or "pressure of work. Expected to meet project deliverables that may require significant time commitments and support.