Plexus Corp. partners with Aerospace/Defense, Healthcare/Life Sciences, and Industrial companies to design, manufacture, and service transformative products. The Intern - Design Assurance Engineer will provide design qualification and engineering support across the product development and manufacturing lifecycle, focusing on safety agency, regulatory compliance, and quality systems. The role also supports prototype development, risk management, design verification, and product compliance activities.
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
Evaluate a product’s Bill of Materials to determine any lifecycle or environmental compliance concerns and investigate alternative solutions to meet the project needs
Qualification
Required
Student working toward a Bachelor's degree in Computer Engineering, Electrical Engineering, Biomedical Engineering, or Software Engineering for entire duration of internship
Preferred
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
Benefits
Medical insurance
Dental insurance
Vision insurance
Paid time off
Retirement savings
Opportunities for professional development
Various development programs designed to accelerate your growth
A variety of perks to enhance the team member experience
Since 1979, Plexus has been partnering with companies to create the products that build a better world.
