Medical Device DHF Specialist & Regulatory Engineer

Real Staffing Group; Northlake (IL); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Real Staffing Group in North Lake County, IL is seeking an Engineer III for medical device/product lifecycle support. The role is primarily onsite with occasional remote work, focusing on maintaining Design History Files, ensuring traceability, and supporting regulatory compliance.

You will execute tests, manage deviations, review data, prepare technical reports, and collaborate with cross-functional teams and external vendors to streamline development processes.

Qualifications

• BS in Engineering (Bioengineering, Chemical, Mechanical) required.
• 3+ years in medical device or pharmaceutical development.
• Experience with DHF management, supplier changes, tests, deviations, and regulatory compliance.
• Strong written and verbal communication skills.

Responsibilities

• Maintain DHF documentation and product traceability.
• Manage supplier and product changes for commercialized devices.
• Support compliance with MDR, ISO 13485, ISO 14971, ISO 10993.
• Execute testing, manage deviations, review data, and prepare technical reports.
• Collaborate with cross-functional teams and external vendors to support lifecycle activities and process improvements.

Skills

DHF management

Supplier changes

Regulatory compliance (MDR ISO 13485 ,

Technical reporting

Communication skills

Education

BS in Engineering (Bioengineering, Chemical, Mechanical)

Job description

Real Staffing Group in North Lake County, IL is seeking an Engineer III for medical device/product lifecycle support. The role is primarily onsite with occasional remote work, focusing on maintaining Design History Files, ensuring traceability, and supporting regulatory compliance.

You will execute tests, manage deviations, review data, prepare technical reports, and collaborate with cross-functional teams and external vendors to streamline development processes.