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Manufacturing Engineer II (First Shift)

Cordis - Irvine, CA

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Job Description

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 Engineer II will be responsible for the development, evaluation, and optimization of manufacturing processes and methods, utilizing knowledge of product design, materials, fabrication processes, tooling, equipment, and quality control standards. Key Responsibilities + Develop highly capable manufacturing processes for existing products in manufacturing. Ensure robust transition from product development thru full rate production ensuring process stabilization. + Develop, and qualify new tooling and equipment + Update FMEAu2019s and QCPu2019s for NPI. + Verification/Validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols. + Create and sustain routers and standards + Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans. + Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems Qualifications Required Skills + Bacheloru2019s Degree in Engineering or related science discipline _[required]_ + Minimum 5 years of experience in a manufacturing environment + Class III, IIb Implantable Medical Device experience + Previous experience working in a clean room environment + 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 take independent decisions + Own project level goals involving multiple engineers + Break down ambiguous tasks into clear milestones to ensure progress can be measured + Knowledge of Validation/Verification process, Gage R&R, and a clear understanding of FDAu2019s QSR and GMP + Strong analytical, problem solving, and project management skills + Fluent in English Pay / Compensation The expected pre-tax pay rate for this position is $76,450 - $102,300 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. Preferred Qualifications 1 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 oneu2019s identity. All our teammateu2019s 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. JOIN OUR TALENT COMMUNITY Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests. Job Locations _US-CA-Irvine_ ID _2025-12148_ 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

Created: 2026-03-07

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