Manufacturing Engineering Technician 1 - Microsphere Lab
3 Days Old
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 Engineering Technician will be responsible for aiding in the development, evaluation, and optimization of manufacturing processes and methods, utilizing knowledge of product design, materials, fabrication processes, tooling, equipment, and quality control standards.
As a Manufacturing Engineer Technician, your responsibilities include:
Assist in the development of highly capable manufacturing processes for existing products in manufacturing
Ensure robust transition from product development through full rate production ensuring process stabilization.
Develop, and qualify new tooling and equipment.
Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols.
Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans.
Help execute the transfer, storage, and disposal of hazardous waste in strict compliance with CAL-OSHA, EPA, and Federal Hazardous Waste Regulations.
Assist in developing and overseeing detailed fabrication schedules for manufacturing runs, optimizing workflow efficiency while balancing resource availability and operational timelines.
Help manage end-to-end inventory control, including purchase order requests, while maintaining safety stock levels and contingency supplies for all fabrication module components, including specialized tools and chemical excipients.
Perform in-process sampling, microscopic visual inspection, and particle analytical testing to ensure adherence to rigorous manufacturing and safety standards.
Maintain compliance and execute the processing and packaging (vialing) of both internal and external microsphere batches, ensuring compliance with GMP and Cordis quality requirements.
Qualifications:
Qualifications
HS diploma or GED
2+ years related work experience in the medical device or pharmaceutical field, or associates degree and equivalent work experience.
Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization
Strong organization and follow-up skills, as well as attention to detail
Ability to make independent decisions
Knowledge of validation verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP
Basic proficiency in SolidWorks and computer-aided design a plus
Strong analytical, problem solving, and project management skills
Fluent in English
Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA, and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards
You must be able to lift and carry up to 25 lbs. .
Pay / Compensation
The expected pre-tax pay rate for this position is $21.15 $26.44 per hour. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Preferred Qualifications:
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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.
- Location:
- Irvine, CA, United States
- Category:
- Architecture And Engineering Occupations