
Sr. Design Assurance Engineer
Actalent, Mundelein, IL, United States
SR Design Assurance Engineer
Exciting project opportunity for 3-6 months! This role can interview virtually next week and start within 2 weeks. Hybrid working schedule after a couple weeks onsite.
Responsibilities
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
Reviewing and auditing DHFs
Focus is analysis and gap identification, not document rewriting
Qualifications
Medical device design controls expertise (21 CFR 820.30 / ISO 13485)
Knowledge of ISO 14971 risk management
Job Type & Location
Contract position based out of Mundelein, IL. Hybrid schedule after a couple weeks onsite.
Pay and Benefits
Pay range: $50.00 - $65.00/hr
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Actalent is an equal opportunity employer.
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Exciting project opportunity for 3-6 months! This role can interview virtually next week and start within 2 weeks. Hybrid working schedule after a couple weeks onsite.
Responsibilities
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
Reviewing and auditing DHFs
Focus is analysis and gap identification, not document rewriting
Qualifications
Medical device design controls expertise (21 CFR 820.30 / ISO 13485)
Knowledge of ISO 14971 risk management
Job Type & Location
Contract position based out of Mundelein, IL. Hybrid schedule after a couple weeks onsite.
Pay and Benefits
Pay range: $50.00 - $65.00/hr
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Actalent is an equal opportunity employer.
#J-18808-Ljbffr