Sr. Manufacturing Engineer, Cordis Innovation

4 weeks ago

Irvine, California, United States Cordis Full time
Job Summary

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

Responsibilities

Develop highly capable manufacturing processes for existing products in manufacturing, ensuring robust transition from product development to full-rate production and process stabilization.
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 risk documents (FMEAs) and Quality Control Plans for New Product Introduction.
Verify and validate processes, machines, and equipment to meet requirements of Company procedures, including IQ/OQ/PQ protocols.
Create and sustain routers and standards.
Troubleshoot product/process-related issues, perform root cause analysis, and develop and implement corrective and preventative action plans.
Actively participate in complaint investigations.
Interface with all internal organizations to support 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.

Requirements

Bachelor's degree in mechanical engineering, biomedical engineering, or a related science discipline.
5+ years of experience in a manufacturing environment.
Class III, IIb Implantable Medical Device experience.
Knowledge of balloon catheters, including mechanical properties and manufacturing processes.
Experience in complaint investigations and an understanding of the complaints handling process.
Previous experience working in a clean room environment.
Strong verbal and written communication skills, with the 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.
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.

What We Offer

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. We strive to create and maintain working and learning environments that are inclusive, equitable, and welcoming. Join us and be part of a team that is dedicated to improving people's lives.

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