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Process Development Engineer II

2 months ago

Beverly Hills, California, United States Medtronic Full time
About This Role

We are seeking a highly skilled Extrusion Process Development Specialist to join our team at Medtronic. As a key member of our Product Development team, you will be responsible for developing and improving extrusion processes to meet the requirements of our delivery catheter systems.

Key Responsibilities
  • Develop new extrusion processes to meet delivery catheter system requirements, ensuring compatibility with processing methods and meeting quality standards.
  • Provide technical and sustaining engineering support in a manufacturing area, recommending and implementing equipment and process modifications to improve production efficiencies and yields.
  • Integrate equipment and material capabilities to meet process module target specifications and technology target specifications, reviewing product development requirements for compatibility.
  • Interact with product design and development personnel to ensure that processes and designs are compatible, leading the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures.
  • Develop manufacturing processes that are applicable to statistical process control, ensuring processes and procedures are compliant with regulations.
Requirements
  • Bachelor's degree in a relevant field, such as engineering or a related field.
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
  • Preferred hands-on-experience in extrusion process development, with 2-5 years of experience.
  • Extrusion experience in developing processes such as multi-lumen extrusion, vacuum forming extrusion, shrink tubing, intermittent/full A/B extrusion, braided catheter extrusion, extruded coating, multilayer co-extrusion, bump tubing, and experience in process validations, statistics, and SPC using Minitab software.
  • Familiarity with design controls, FDA regulation - ISO 13485, 21 CFR 820, and CGMP practices, good working knowledge of GD&T, and ability to generate and conduct validations independently.
What We Offer

As a member of our team, you will have the opportunity to work on cutting-edge projects, collaborate with experienced professionals, and contribute to the development of innovative medical devices that improve patient outcomes. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.