Manufacturing Engineering Technician III

Overview

Manufacturing Engineering Technician III — Contract / Full-Time | Onsite - Or visiting suppliers in the area 5-days/week | 8:30am-5pm PST |

Location:

Huntington Beach Office, CA (Must be local to the Orange County area)

Join a medical device company. They are creating one of the world’s most advanced artificial hearts — a fully implantable titanium device powered by a magnetically levitated rotor — aimed at replacing human heart function permanently or serving as a bridge-to-transplant.

• Associate degree or certification in Engineering Technology, Mechanical Engineering, Biomedical Engineering, or a related field; or equivalent hands‑on experience.
• 3 years of experience in manufacturing, assembly, or production—preferably in medical devices, pharmaceuticals, or other regulated industries.
• Valid driver s license.
• Ability to work independently and collaboratively in a regulated environment.
• Perform light material handling tasks, including lifting up to 35 pounds for short durations.
• Ability to sit for extended periods, including 8+ hour shifts. Frequent keyboard and computer use.
• Willingness and ability to wear full cleanroom attire (gown, gloves, mask, etc.) for entire shifts
  .

• Supporting the development, improvement, validation, troubleshooting, and scaling of assembly, equipment, and test processes for a Class III medical devices

• Set up, operate, and maintain production and test equipment in accordance with manufacturing instructions and quality standards.
• Support equipment qualifications (IQ/OQ/PQ), process validations, and test method validations.
• Perform routine maintenance and calibration to ensure optimal equipment performance.
• Troubleshoot and resolve equipment issues to minimize downtime.
• Build products in compliance with environmental controls, hygiene requirements, procedures, and work instructions.
• Develop and support assembly and test fixtures per approved documentation.
• Inspect incoming supplier components against quality inspection requirements.
• Test, inspect, and measure finished products, components, and devices to verify compliance with functional specifications.
• Troubleshoot, adjust, repair and perform root‑cause analysis on finished products and components.

• Assist in the development, optimization, and documentation of manufacturing processes.
• Support engineers in implementing process improvements to enhance efficiency, quality, and cost.
• Assist Quality and Purchasing teams with inventory tracking and documentation.
• Support the creation, modification, review, and execution of work instructions, assembly drawings, manufacturing processes, protocols, reports, records, and engineering change documentation.

• Conduct in‑process and final inspections to ensure products meet quality and regulatory requirements.
• Document and report nonconformances and defects.
• Support failure analysis, root‑cause investigations, and corrective and preventive actions (NCRs, CAPAs).
• Maintain cleanroom and controlled‑manufacturing environments in compliance with housekeeping, ESD, and 5S standards.

• Maintain accurate records related to equipment maintenance, calibration, and process changes.
• Ensure compliance with FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP).

• Provide technical support, training and collaborate with manufacturing operators, quality personnel, and production teams on equipment and processes.

• Identify opportunities for process, equipment, and workflow improvements.
• Participate in Lean Manufacturing, Six Sigma, and other continuous improvement initiatives as required.

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