Our people create our best Plexus.
WHAT WE DO AT PLEXUS
We’re a global team of over 19,000 engineering, manufacturing, supply chain and aftermarket service experts who partner 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.
At Plexus, you are more than just an intern. We embrace your innovative ideas and collaborative thinking. You play a critical role in our success as we continue to grow as a global organization.
WHY WE LOVE IT
Engaging and challenging projects that fulfill and develop you. People that inspire and empower you to realize your full potential. A workplace centered on inclusion and collaboration. At Plexus, we’re at our best when opportunities are met with passion, open communication and teamwork.
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. Because of this, we encourage people of all backgrounds to apply to our positions, and will look at candidates holistically, balancing work, education and additional experiences.
HOW YOU WILL DO IT
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 Computer Engineering, Electrical Engineering, Biomedical Engineering, or Software Engineering for entire duration of internship.
PREFERRED QUALIFICATIONS
- 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
Some offers of employment are contingent upon successfully passing a drug screen and upon completion of a confidentiality agreement.
Our Values and How We Lead behaviors guide our processes. Plexus does not make employment decisions based on race, color, religion, national origin, sexual orientation, gender identity, disability, or veteran status. We are proud to be an Equal Opportunity Employer (EOE) and encourage all to apply today!
We are pleased to provide reasonable accommodations to individuals with disabilities or special requirements. If you need an application accommodation, please contact us by email at [email protected]. Please include your contact information and clearly describe how we can help you.
The email address above is for accommodation requests only and cannot be used to inquire about the status of applications.
