Manufacturing Engineer II

4 weeks ago

Irvine, California, United States Cordis Full time
Overview

Cordis, a pioneering medical technology company, is seeking a highly skilled Manufacturing Engineer II to join our team in Irvine. As a key member of our manufacturing team, you will be responsible for developing, evaluating, and optimizing manufacturing processes and methods for our groundbreaking medical devices.

We are committed to delivering transformative medical solutions that improve the lives of millions. Our team is passionate about innovation, collaboration, and excellence, and we are looking for a talented individual who shares our values.

Responsibilities
  • Develop highly capable manufacturing processes for existing products in manufacturing, ensuring robust transition from product development to full-rate production.
  • Develop and qualify new tooling and equipment, ensuring compliance with quality control standards.
  • Draft design of a workspace, including materials and equipment, using computer drafting programs.
  • Update FMEAs and QCPs for NPI, ensuring accurate and timely documentation.
  • Verify and validate processes, machines, and equipment to meet company procedures, including IQ/OQ/PQ protocols.
  • Create and sustain routers and standards, ensuring efficient and effective manufacturing operations.
  • Troubleshoot product/process-related issues, perform root cause analysis, and develop corrective and preventative action plans.
  • Interface with internal organizations to support new product development, introductions, technologies, and supporting systems.
  • Work with vendors to identify operational equipment and automation solutions, ensuring optimal manufacturing performance.
  • Develop and manage project plans for major operational improvement activities, ensuring timely and effective implementation.
Qualifications
  • Bachelor's degree in engineering or a related science discipline.
  • 2+ years of experience in a manufacturing environment, with a focus on medical devices.
  • Class III, IIb Implantable Medical Device experience, with a strong understanding of FDA regulations and GMP standards.
  • Previous experience working in a clean room environment, with a focus on quality and compliance.
  • Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels in the organization.
  • Strong organization and follow-up skills, with attention to detail and a focus on delivering high-quality results.
  • Ability to work effectively in a team environment, with a focus on collaboration and mutual respect.
  • Ability to own project-level goals, with multiple engineers, and break down ambiguous tasks into clear milestones.
  • Knowledge of Validation/Verification process, Gage R&R, and a clear understanding of FDA regulations and GMP standards.
  • Working knowledge of process flow, value stream analysis, operations demands, and operator requirements.
  • Proficiency in CAD software, such as Solidworks, for 3D modeling, design analysis, and manufacturing drawings.
  • Understanding of statistical analysis, with a focus on data-driven decision-making.
  • Ability to compose thorough and detailed technical documentation, job aids, procedures manuals, and other relevant materials.
  • Strong analytical, problem-solving, and project management skills, with a focus on delivering high-quality results.
What We Offer

Cordis is proud to offer a competitive salary range of $73,700 - $100,000, depending on skills, education, experience, job-related knowledge, and location. We also offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

We are an equal opportunity employer, committed to fostering an inclusive work environment that values diversity and promotes belonging. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated, and encouraged to be their authentic selves.

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 us.

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