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Principal Manufacturing Engineer, Selution
4 days ago
Cordis Irvine, United StatesOverview: · 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 healt ...
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Sr. R&D Engineer, Selution
1 week ago
Cordis Irvine, United StatesOverview: · 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 healt ...
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Principal Manufacturing Engineer, Selution
2 weeks ago
Cordis Irvine, United StatesOverview · 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 healthc ...
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Principal R&D Engineer, Selution
3 weeks ago
Cordis Irvine, United StatesOverview: · 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 healt ...
-
Principal R&D Engineer, Selution
3 weeks ago
Cordis Irvine, United StatesOverview · 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 healthc ...
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Quality Assurance Director, Selution
2 weeks ago
Cordis Irvine, United StatesOverview: · 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 health ...
Sr. Manufacturing Engineer, Selution - Irvine, United States - Cordis
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Description
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).
The Sr. Manufacturing Engineer 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.
Draft design of a workspace, including materials and equipment, using computer drafting programs.
Update FMEAs and QCPs 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.
Work with vendors to identify operational equipment and automation solutions.
Develop and manage project plans for major operational improvement activities.
Bachelors degree in engineering or related science discipline [required]
5+ years of experience in a manufacturing environment [required]
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 work effectively in a team environment
Must be able to work under minimal supervision
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 FDAs QSR and GMP
Working knowledge of process flow, value stream analysis, operations demands and operator requirements.
Ability to compose thorough and detailed technical documentation, job aids, procedures manuals, etc.
Strong analytical, problem solving, and project management skills
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
Pay / Compensation
The expected pre-tax pay rate for this position is $99,000 $123,750
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.
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 ones 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.