Manufacturing Engineering Technician III

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.
 

Qualifications

• 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

Responsibilities: 

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

Equipment Maintenance & Calibration

• 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.

Process Support

• 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.

Quality Assurance

• 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.

Documentation & Compliance

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

Collaboration & Training

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

Continuous Improvement

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

The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process, Apply, and please feel free to reach out.