Job Description

Design Assurance Engineer

At Plexus, our vision is to help create the products that build a better world. Driven by a passion for excellence, we partner with leading Aerospace/Defense, Healthcare/Life Sciences and Industrial companies to design, manufacture and service some of the world's most transformative products, including advanced surgical systems, diagnostic instruments, healthcare imaging equipment, mission critical aerospace systems, and electric vehicle (EV) charging solutions.

When we invest in our people, we invest in building a better world. With a vision rooted in the wellbeing and inclusive engagement of our team members, our customers, their end users and our communities, people are the heart of what we do and who we are. It is our values that unite us and guide us in everything that we do, including how we operate, behave and interact to foster a workplace where every team member feels valued and empowered to contribute their best.

Our values include: Growing our People, Building Belonging, Innovating Responsibly, Delivering Excellence and Creating Customer Success. As a team member, you will engage in impactful work through global collaboration and the use of emerging technologies, join an inclusive culture where every team member is valued and working toward a greater purpose, and be empowered to reach your full potential through various development programs designed to accelerate your growth.

Our commitment to pay range transparency fosters an equitable workplace, where everyone can feel valued. The annual compensation range for this position is stated below. The salary offered within this range will be based upon the geographic location, work experience, education, licensure requirements and/or skill level. Salary Range:

$36,700.00 - $55,100.00

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

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.

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 GHQ.TA@plexus.com. Please include your contact information and clearly describe how we can help you. This email is for accommodation requests only and cannot be used to inquire about the status of applications.

We are an Equal Opportunity Employer (EOE) and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Some offers of employment are contingent upon successfully passing a drug screen and/or background check.

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