Quality Engineer

Quality Engineer - DHF

Location: North Lake County, IL (Primarily onsite, with limited remote flexibility)
Pay: $58-$62/hr
Duration: 1 year with potential to extend/convert based on performance and budget
Schedule: Monday-Friday, 40 hours per week

Job Description
The Engineer III will support on-market medical device products through product lifecycle management, DHF, supplier change execution, and manufacturing support. This role will focus on maintaining product design documentation, ensuring regulatory compliance, and supporting product changes throughout the product lifecycle. The engineer will collaborate with cross-functional teams and external vendors to implement changes, resolve development challenges, and improve processes supporting marketed products.

Responsibilities

• Execute on-market product changes and support product lifecycle management activities.
• Maintain and manage Design History Files (DHF) and ensure appropriate documentation and traceability.
• Support supplier changes and product design updates for marketed medical devices.
• Review and execute testing activities, manage deviations, analyze data, and prepare technical reports.
• Ensure compliance with applicable global regulatory requirements and industry standards.
• Provide manufacturing and product design support throughout the product lifecycle.
• Collaborate with cross-functional teams and external vendors to communicate technical challenges and implementation strategies.
• Standardize and simplify team processes to improve efficiency in product development and ongoing product support.

Requirements

• Bachelor's degree in Bioengineering, Chemical Engineering, Mechanical Engineering, or a related technical field.
• 3+ years of experience in medical device or pharmaceutical development.
• Experience with Design History Files (DHF), product lifecycle management, and documentation traceability.
• Experience executing on-market supplier changes.
• Knowledge of applicable regulatory requirements and industry standards, including MDR, ISO 13485, ISO 14971, and ISO 10993.
• Proficiency in test execution, deviation management, data review, and technical report writing.

Preferred Qualifications

• Graduate degree in a technical or scientific field.
• Experience with combination medical device or pharmaceutical product development.

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