Manufacturing Operator II (Microspheres)

Cordis • Irvine, CA • 8h ago

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 Operator II (Microspheres) supports the preparation, mixing, inspection, filtration, and documentation of solutions used in the production of drug-loaded polymer microspheres. This role performs controlled manufacturing activities following approved Manufacturing Instructions, work instructions, and GMP requirements to ensure product quality, safety, and compliance.

Key Responsibilities

Prepare solutions (weighing, mixing, heating, cooling, sampling, filtration)

Operate mixers, jacketed tanks, TCU, peristaltic pumps, ultrasonic baths, bottle rollers, balances

Perform in-process inspections and environmental controls

Complete batch records and control documentation accurately

Follow line clearance, cleaning, PPE, and safety requirements

Escalate deviations or out-of-spec results to supervision/engineering

Operating machinery to produce medical devices to meet the specifications.

Following manufacturing instructions and updating the relevant job documentations accurately for traceability.

Product packing and sterilization preparation.

Product inspection using microscope.

Perform setup, verification of, and teardown of equipment before and after processing.

Prepare solutions and production materials.

Perform manufacturing tasks, including fabrication, in-process testing, and packaging.

Document production activities in manufacturing lot history records.

Clean up production equipment and production area.

Perform analysis of data (as needed)

Troubleshoot product/process related issues.

Work with chemicals and powders in a lab environment.

Other duties may be assigned

Qualifications

Required Qualifications

High-school diploma or equivalent.

Minimum 2 years of experience in a regulated manufacturing environment, preferably medical devices.

Proficiency in reading and following manufacturing instructions and drawings.

Strong attention to detail, manual dexterity, and visual acuity for small-part assembly.

Basic computer skills for data entry and documentation.

Adequate eyesight to ensure effective inspection of product, labeling and packaging. (Use of corrective lenses is acceptable).

Ability to work with potentially hazardous chemicals and safe handling of chemicals

Ability to work overtime and/or weekends, according to business need.

Fluent in English.

Preferred Qualifications

Experience with drug-coated balloons or catheter production.

Experience with solution preparation, filtration, and sampling

Familiarity with cleanroom/controlled environments

Familiarity with cleanroom protocols and quality documentation systems (e.g., QMS or ERP platforms).

Key Competencies

Dependable, punctual, and quality-focused.

Excellent teamwork and communication skills.

Ability to multitask and maintain accuracy under time constraints.

Positive, solution-oriented attitude toward process improvement.

Commitment to safety, cleanliness, and regulatory compliance.

Working Conditions

Cleanroom and controlled manufacturing environment.

Standing and/or sitting for extended periods.

Frequent use of microscopes, small tools, and measuring equipment.

Light lifting (up to 25 lbs.).

Must wear required PPE and adhere to EHS policies.

Pay / Compensation

The expected pre-tax pay rate for this position is $26.00 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

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 teammates' 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.

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Job Locations US-CA-Irvine

ID 2026-12791

Category Manufacturing

Position Type Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com

Cordis

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