
Job Information
Cordis Manufacturing Engineer II (Selution) in Irvine, California
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).
If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you. Join us, and let’s improve the wellbeing of millions, together.
We are the people behind the people who keep saving lives.
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
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.
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 2025-3494
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
-
- Cordis Jobs