Medical Device DHF & Lifecycle Engineer — Onsite IL

Real; Orland Park (IL); Hybrid; USD 95,000 - 130,000; Full time

Job summary

Specialist Staffing Group is seeking an Engineer III for medical device/product lifecycle support in North Lake County, IL, primarily onsite with occasional remote work depending on project requirements. You will maintain Design History Files (DHF), oversee supplier changes, and support regulatory compliance across MDR and ISO standards.

The role requires a BS in Engineering (bioengineering, chemical or mechanical) with 3+ years in medical device or pharmaceutical development, strong written and

Qualifications

• Experience with DHF management and regulatory compliance.
• Familiarity with MDR, ISO 13485, ISO 14971, ISO 10993 requirements.
• Strong written and verbal communication skills.

Responsibilities

• Maintain DHF documentation and product traceability.
• Manage supplier and product changes for commercialized devices.
• Support MDR/ISO regulatory requirements and related standards.
• Execute testing, manage deviations, review data, and prepare technical reports.
• Collaborate with cross-functional teams and external vendors on lifecycle activities.

Skills

DHF management

Supplier changes

MDR requirements

ISO 13485

ISO 14971

ISO 10993

Education

Bachelor's degree in Engineering (Bioengineering, Chemical, Mechanical, or related)

Advanced degree in technical/scientific field

Job description

Specialist Staffing Group is seeking an Engineer III for medical device/product lifecycle support in North Lake County, IL, primarily onsite with occasional remote work depending on project requirements. You will maintain Design History Files (DHF), oversee supplier changes, and support regulatory compliance across MDR and ISO standards.

The role requires a BS in Engineering (bioengineering, chemical or mechanical) with 3+ years in medical device or pharmaceutical development, strong written and