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Design Assurance Engineer Internship

2 months ago


Raleigh, North Carolina, United States Plexus Full time

About Plexus

Plexus is a global company that partners with customers to bring their products to life through inspired innovation and world-class customer service.

We are passionate about innovating, creating, and delivering products that change people's lives. From surgical devices and health monitors to warehouse robotics and space products, we partner with our customers to help create the products that build a better world.

Our Culture

We believe that our people create our best Plexus. At Plexus, we value the ideas generated by our collective uniqueness and recognize that the diverse backgrounds, life experiences, and perspectives of our team members enable us to create the innovative products that build a better world.

Job Summary

The Design Assurance Engineer will provide design qualification and engineering support throughout all stages of the product development and manufacturing lifecycle. The DA engineer will serve as the focal point for the project team and the customer on topics related to safety agency and regulatory compliance as well as the necessary quality system(s).

Responsibilities

  • Ensure that the planned project activities are compliant with Plexus' Standard Operating Procedures, ISO (i.e., quality systems, FDA Quality System Regulations (QSR), REACH and RoHS directives, and medical device standards (i.e., IEC as applicable for each unique product.
  • Direct the development and assembly of prototypes by authoring and reviewing product documentation in accordance with quality and change management procedures and guidelines. Provide documentation and technical assistance to design engineering staff and material procurement team to ensure high-quality prototypes are built in a timely manner.
  • Participate in the Plexus quality system development and maintenance.
  • Demonstrate proficiency using lab equipment and debug techniques to ensure electro-mechanical products meet design requirements.
  • Determine appropriate specifications to comply with regulatory and compliance requirements of intended markets, and facilitate documentation of such specifications.
  • Lead the development of the product Risk Management Plan, Design Failure Modes and Effects Analyses, and Fault Tree Analyses as necessary to comply with ISO 14971 requirements.
  • Participate in all Design Verification test activities, including generation of the Verification Plan, Procedures, Traceability Matrix, and Report documents, as well as prototype test execution.

Requirements

  • Student working toward a Bachelor's degree in Computer Engineering, Electrical Engineering, Biomedical Engineering, or Software Engineering for the entire duration of the internship.
  • Sophomore or Junior level status
  • GPA: 3.0 or higher is preferred