Demo

Manufacturing Engineer II, Selution (Second Shift)

Cordis
Irvine, CA Full Time
POSTED ON 2/22/2025
AVAILABLE BEFORE 5/18/2025
  • Overview
  • Cordis is a pioneering medical technology company specializing in groundbreaking 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 four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

    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 lets improve the wellbeing of millions, together.

    We are the people behind the people who keep saving lives.

    • 2nd shift 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.
    • 2nd Shift 2 : 00p.m. - 10 : 30p.m.
    • 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
    • Bachelors 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.

    • 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_
    • 2024-3118_
    • 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

    Salary : $73,700 - $100,000

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