Manufacturing Engineering Technician I (First Shift)

Selution, in partnership with Cordis, specializes in the development of groundbreaking 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.

As a Manufacturing Engineer Technician I, 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

• HS diploma or GED 
• 2+ years related work experience in the medical device or pharmaceutical field, or associate’s 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 $21.95–$27.50 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.