Intern - Design Assurance Engineer - Fall 2024

Plexus Corp.

2mo ago

Internship
Full-time
Summer Internship
Software Engineering
Engineering
Neenah
Quick Apply

AI generated summary

You must be a sophomore or junior student studying engineering with a 3.0+ GPA. Knowledge of medical device safety standards and regulatory requirements is essential.
You will ensure compliance with quality systems and regulations, assist in prototype development, maintain design documentation, conduct testing and analysis, and contribute to risk management and verification activities in a dynamic engineering environment.

Requirements

Student working toward a Bachelor’s degree in Computer Engineering, Electrical Engineering, Biomedical Engineering, or Software Engineering for entire duration of internship.
Sophomore or Junior level status
GPA: 3.0 or higher is preferred
Working knowledge of medical device and similar safety standards (i.e. IEC 60601-1, IEC 61010-1)
Understanding of regulatory requirements

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.

Plexus Corp.

We help create the products that build a better world.

Manufacturing & Electronics

Industry

10,001+

Employees

1979

Founded Year

Mission & Purpose

Since 1979, Plexus has been partnering with companies to create the products that build a better world. We are a team of over 25,000 individuals who are dedicated to providing Design and Development, Supply Chain Solutions, New Product Introduction, Manufacturing and Aftermarket Services. Plexus is a global leader that specializes in serving customers in industries with highly complex products and demanding regulatory environments. Plexus delivers customer service excellence to leading companies by providing innovative, comprehensive solutions throughout a product’s lifecycle