Manufacturing Engineer II, Selution

4 weeks ago


Irvine, California, United States Cordis Full time
Overview
Cordis is a pioneering medical technology company that specializes in innovative solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases.

With a strong focus on delivering transformative medical solutions, Cordis is leading the way in improving the lives of millions. If you are passionate about making a difference and have a strong background in manufacturing and engineering, then this is the perfect opportunity for you.

We are seeking a highly skilled Manufacturing Engineer II to join our team. The successful candidate 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.

Qualifications
Bachelor's degree required, engineering or related degree preferred
2+ 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
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.
Proficiency in CAD software (e.g. Solidworks) for 3D modeling, design analysis and manufacturing drawings.
Understanding of statistical analysis
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 $73,700 - $100,000
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.

Why Work at Cordis

Cordis is a company that values diversity, equity, and inclusion. We believe that our differences are what make us stronger and more innovative. If you are passionate about making a difference and have a strong background in manufacturing and engineering, then this is the perfect opportunity for you.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. 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



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