Design Assurance Engineering Intern

Location

Maple Grove, MN | United States

Job description

SUMMARY: This role aims to provide a comprehensive understanding of design assurance engineering to support the life cycle of medical devices. Design Assurance Engineers collaborate with the development, manufacturing, and quality teams to ensure that devices are designed in compliance with product requirements, ISO 13485, and 21 CFR 820. They are responsible for developing and maintaining risk management plans, sterilization plans, auditing the Design History File (DHF) requirements, and providing feedback on product requirements, risk assessments, and verification methods.

DUTIES AND RESPONSIBILITIES:

• Assist in guiding the design control process for product development projects.
• Review and provide feedback on project design and development deliverables for assigned projects.
• Assist in creating verification plans, reports, and test procedures for design verification deliverables.
• Participate in design verification testing.
• Perform data analysis for characterization and verification testing.
• Collaborate with the R&D team to conduct risk assessment for product design and manufacturing processes.
• Ensure clear documentation in the DHF regarding the trace relationships between design inputs and design outputs.
• Collaborate with engineers in troubleshooting test anomalies and non-conformances in development builds.

Requirements

To be considered for this position, you must:

• Be currently enrolled in a bachelor's or master's degree program in electrical engineering, software engineering, mechanical engineering, biomedical engineering, or a related field.
• Have a cumulative GPA of 3.0 or above.
• Possess excellent attention to detail, organization, time management, and accuracy.
• Demonstrate strong problem-solving and analytical skills.
• Have excellent written and verbal communication abilities.
• Be familiar with statistical software, such as Minitab (preferred).
• Have intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook).

Job tags

Salary