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Manufacturing Engineering Technician II
- Irvine, California, United States
- Irvine, California, United States
Über
Overview:
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.
Responsibilities:
The Manufacturing Technician II performs advanced production support and technical tasks to ensure consistent and efficient manufacturing of combination medical devices. This role assists with equipment setup, troubleshooting, process improvement, and validation support while maintaining compliance with all regulatory and quality standards.
As a Manufacturing Technician II, your responsibilities include:
- Perform advanced setup, operation, and maintenance of manufacturing equipment and tooling.
- Support process validation and qualification activities (IQ/OQ/PQ) under engineering guidance.
- Troubleshoot minor equipment and process issues to minimize downtime.
- Assist in implementing process improvements and corrective actions.
- Document production data, maintenance logs, and process changes in accordance with GDP.
- Support operator training and provide hands-on technical guidance as needed.
- Collaborate with Engineering, Quality, and Maintenance teams to ensure product quality and process control.
- Participate in material handling, line changeovers, and equipment calibration.
- Identify opportunities for improvement in workflow, safety, or quality.
Qualifications:
Required Qualifications
- High-school diploma or equivalent; technical training preferred.
- Minimum 2+ years of experience in a regulated manufacturing environment.
- Strong mechanical aptitude and familiarity with manufacturing equipment operation.
- Working knowledge of GMP, GDP, and cleanroom practices.
Preferred Qualifications
- Experience with combination products or catheter manufacturing.
- Familiarity with process validation or data collection tools.
- Basic understanding of lean manufacturing principles.
Working Conditions
- Cleanroom and production floor environments.
- Standing or sitting for extended periods.
- Light lifting (up to 25 lbs.)
- Must wear PPE and follow gowning, safety, and 5S procedures.
Pay / Compensation
The expected pre-tax pay rate for this position is $23.27 – $29.09 per hour. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
Preferred Qualifications:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.
Sprachkenntnisse
- English
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