Intern – Design Assurance Engineer

OVERVIEW

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. 13485) quality systems, FDA Quality System Regulations (QSR), REACH and RoHS directives, and medical device standards (i.e. IEC 60601) 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.

MINIMUM QUALIFICATIONS

• Student working toward a Bachelor’s degree in Industrial Engineering, Electrical/Electronic Engineering, Biomedical Engineering for the entire duration of internship.

PREFERRED QUALIFICATIONS

• Last 2 semesters of Engineering degree
• Average of 8 or higher is preferred
• Good English writing and communication skills is desired
• Working knowledge of medical device and similar safety standards (i.e. IEC 60601-1, IEC 61010-1)
• Understanding of regulatory requirements

This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform.