Intern - Design Assurance Engineer (Summer 2026) at Plexus

Neenah, Wisconsin, United States

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Not SpecifiedCompensation

InternshipExperience Level

InternshipJob Type

UnknownVisa

Aerospace, Defense, Healthcare, Life Sciences, IndustrialIndustries

Requirements

Knowledge of 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
Ability to author and review product documentation in accordance with quality and change management procedures and guidelines
Proficiency using lab equipment and debug techniques for electro-mechanical products
Ability to determine appropriate specifications to comply with regulatory and compliance requirements of intended markets
Ability to lead development of product Risk Management Plan, Design Failure Modes and Effects Analyses, and Fault Tree Analyses per ISO 14971
Ability to participate in Design Verification test activities, including generation of Verification Plan, Procedures, Traceability Matrix, and Reports

Responsibilities

Ensure 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
Direct the development and assembly of prototypes by authoring and reviewing product documentation; provide documentation and technical assistance to design engineering staff and material procurement team for high quality, timely prototypes
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 Reports
Provide design qualification and engineering support throughout all stages of the product development and manufacturing lifecycle
Serve as the focal point for the project team and the customer on topics related to safety agency and regulatory compliance as well as necessary quality system(s)

Skills

Plexus

Manufactures and repairs medical devices

About Plexus

Plexus Corp. offers engineering and manufacturing services tailored for medical device manufacturers, focusing on aftermarket repair and maintenance for drug delivery devices. Their services lead to a 50% improvement in turnaround times and a 25% reduction in service costs, while also minimizing quality issues. Plexus stands out by providing end-to-end solutions, utilizing tools like the Strategic Mitigation Action Response Tracker (SMART) to enhance supply chain efficiency. The company's goal is to deliver specialized, high-quality solutions that improve operational efficiency and reduce costs for their clients.

Oradea, RomaniaHeadquarters

1979Year Founded

IPOCompany Stage

Robotics & Automation, HealthcareIndustries

5,001-10,000Employees

Benefits

Professional and personal development

Plexus Global Mentor Program

Accessible Resources

Risks

Closure of Portland facility may indicate operational challenges affecting workforce stability.

Partnership with Simbe Robotics could strain resources if demand exceeds production capabilities.

Integration with Gate Web3 Wallet may expose Plexus to cybersecurity risks.

Differentiation

Plexus offers end-to-end solutions from design to maintenance in multiple sectors.

The company specializes in aftermarket repair for medical devices, improving efficiency and cost.

Plexus's Strategic Mitigation Action Response Tracker aids in predictive risk management.

Upsides

Partnership with Simbe Robotics expands Plexus's role in the growing retail automation market.

Acquisition of a new office building suggests potential for expanded design and development services.

Collaboration with Arch Systems enhances Plexus's Industry 4.0 capabilities for better efficiency.

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