Design Assurance Engineer

Medline Industries, LP • Northfield, IL

123d • $79,560 - $115,440

About The Position

The Design Assurance Engineer provides critical oversight and governance of our Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements. This role is essential for guiding and approving design controls, facilitating design transfer, and managing risk files. It ensures that all processes and documentation meet the high standards appropriate for our various product lines, including Class I, and Class II 510k devices. The Design Assurance Engineer ensures that our products are developed and transferred to manufacturing with the highest level of quality and regulatory compliance, and ensuring design changes are appropriately documented and kept current.

Responsibilities

• Oversee the creation, maintenance, and review of DHFs to ensure completeness, accuracy, and compliance with regulatory standards.
• Support R&D/QA/RA teams in new product development and remediation activities, providing guidance and approval for design control documents.
• Collaborate with cross-functional teams to ensure design control activities are integrated into the product development lifecycle.
• Sign off on appropriate design control files as independent reviewer as needed.
• Review and govern the design transfer process, ensuring documentation and knowledge from development to manufacturing is accurately communicated.
• Contribute to the assembly, maintenance, and tracking of Design History Files, ensuring they are appropriately managed.
• Ensure DHF procedures are relevant, thorough, and unambiguous.
• Provide guidance and training to the Medline R&D and Quality team regarding DHF procedures and best practices.
• Provide governance on design change process and documentation.

Benefits

• Health insurance
• Life and disability insurance
• 401(k) contributions
• Paid time off
• Access to Employee Assistance Program
• Access to Employee Resource Groups
• Access to Employee Service Corp

What This Job Offers

• Number of Employees: 5,001-10,000 employees