Manufacturing Engineer II (United States)

Cordis • Irvine, CA • 6h ago

Overview

MedAlliance, 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. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

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.

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 FMEA's and QCP's 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

Bachelor's Degree in Engineering or related science discipline [required]

3-5 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 FDA's 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

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.

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Job Locations US-CA-Irvine

ID 2025-12070

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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