Manufacturing Engineer I (second shift)

CordisIrvine, CA
2d$69,500 - $87,250

About The Position

Selution, 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. The Manufacturing Engineer I (second shift) is responsible for developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability, implements process improvements to reduce product cost, process cycle time and improved product quality.

Requirements

  • Bachelor’s degree in engineering (Mechanical, Biomedical, Robotics or equivalent) and 2+ years related work experience, preferably in a medical device manufacturing environment.
  • Excellent hands‐on communication and interpersonal skills.
  • Experienced in MS office tools (Word, Excel, PowerPoint, Project etc.).
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Nice To Haves

  • Experience in Design for Manufacturing (DFM), Design of Experiments (DOE), Design and Process Failure Mode and Effects Analysis (FMEA) is a plus.
  • Experience with CAD Software (Solid Works & AutoCAD) preferred.

Responsibilities

  • Create documentation to support new and improved manufacturing processes
  • Write and perform process validations
  • Make recommendations for equipment purchases based upon manufacturing needs
  • Perform IQ/OQ/PQ as required on equipment
  • Disposition NCR’s and CAPA’s as assigned
  • Perform experiments including but not limited to DOE’s to characterize and improve processes
  • Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis
  • Coordinate with suppliers and external resources needed in developing and implementing new processes
  • Work closely with R&D and Manufacturing to capture and interpret design intent in order to refine and improve processes
  • Facilitate excellent communications between all team members
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