Manufacturing Engineer

Role: Manufacturing Engineer

Location: Irvine, CA, 92614

Duration: 10 Months (W2)

Work Arrangement: Onsite

Key Skills and Requirements:

• At least 3 years of hands-on experience in medical device manufacturing.
• Strong troubleshooting skills to resolve issues with manufacturing equipment and devices.
• Proven experience conducting equipment and process qualifications in a regulated environment.
• Familiarity with Design of Experiments (DOE) and Statistical Process Control (SPC) is an added advantage.
• Experience working with SAP and Windchill systems is preferred.
• Ability to work autonomously, managing tasks and responsibilities efficiently without direct supervision.

Responsibilities:

• Provide critical support during the production process, ensuring efficient ramp-up and smooth operation of manufacturing lines.
• Address and resolve issues affecting production flow, including troubleshooting device and equipment malfunctions.
• Conduct comprehensive qualifications for manufacturing equipment and processes to meet regulatory and operational requirements.
• Collaborate with cross-functional teams to validate and optimize manufacturing processes.
• Manage and oversee equipment installations, ensuring proper setup and functionality.
• Implement and monitor preventive maintenance schedules to minimize downtime and maintain product quality standards.
• Ensure compliance with product quality standards by closely monitoring manufacturing processes and addressing any deviations.
• Document findings and provide detailed reports to stakeholders.

Qualifications:

• Bachelor’s Degree in Engineering (Mechanical or Biomedical preferred).
• Strong analytical, problem-solving, and communication skills.
• Proactive and self-motivated, with the ability to manage multiple priorities effectively.

Top Skills Required:

• Process Qualification
• Equipment Qualification
• Troubleshooting
• Manufacturing Line Support