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Sr. Design Assurance Engineer
Job summary
Work model
Job Summary
This is an exciting contract opportunity for a Sr. Design Assurance Engineer, with a duration of 3-6 months. The role offers a hybrid working schedule, requiring some initial onsite presence in Libertyville, IL, followed by a flexible hybrid arrangement. Interviews can be conducted virtually next week, with a potential start date within two weeks.
Responsibilities
The primary focus of this role is to perform a structured, end-to-end Design History File (DHF) audit and gap assessment. Key areas of review include:
- Design & Development Plan
- User Needs
- Design Inputs
- Design Outputs
- Design Verification
- Design Validation
- Risk Management Files (ISO 14971)
- Design Reviews and Traceability
- Linkage across DHF elements
Qualifications
- Medical device design controls expertise (21 CFR 820.30 / ISO 13485)
- Experience reviewing and auditing DHFs
- Knowledge of ISO 14971 risk management
- The role emphasizes analysis and gap identification, not document rewriting.
Job Type & Location
- Contract position
- Location: Libertyville, IL
- Workplace Type: Hybrid
Pay and Benefits
- Pay Range: $50.00 - $65.00/hr
- Eligible benefits may include: Medical, dental & vision, Critical Illness, Accident, and Hospital, 401(k) Retirement Plan, Life Insurance, Short and long-term disability, Health Spending Account (HSA), Transportation benefits, Employee Assistance Program, Time Off/Leave (PTO, Vacation or Sick Leave). Eligibility requirements apply.
Application Deadline
- Anticipated closing date: Apr 23, 2026
Diversity, Equity & Inclusion
Actalent is committed to fostering diversity, equity, and inclusion. We strive to hire diverse talent, maintain an inclusive environment, build a culture of care and recognition, and ensure growth opportunities for our people. Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services with over 40 years of experience. Headquartered in the United States, we have 150 offices across North America, EMEA, and APAC, and four delivery centers in India. We serve over 4,500 clients, including many Fortune 500 brands, across various industries. Learn more at actalentservices.com.