Senior Systems Engineer (Medical Device
Job in
Bloomington, McLean County, Illinois, 61791, USA
Listed on 2026-08-13
Listing for:
Staftonic LLC
Full Time
position Listed on 2026-08-13
Job specializations:
-
Engineering
Systems Engineer, Biomedical Engineer, Quality Engineering, Medical Device Industry
Job Description & How to Apply Below
Senior Systems Engineer (Medical Device)
Long-Term Project
Responsibilities:
- Lead and facilitate Use-Related Risk Analysis (URRA) activities.
- Coordinate with Human Factors, Quality, Clinical, Medical Safety, Manufacturing, and R&D teams.
- Develop and maintain Design Control documentation and Design History Files (DHF).
- Support Systems Engineering activities including requirements management, traceability, system architecture, and change management.
- Participate in Design FMEA, Process FMEA, and product risk assessments.
- Ensure compliance with FDA Design Controls and applicable regulatory standards.
- Drive project schedules, risk mitigation, and documentation readiness.
Required Qualifications:
- BS in Engineering, Science, or related discipline with 10+ years of experience (or MS with 8+ years).
- 5+ years of experience in Medical Device, Combination Products, Pharmaceutical, or other regulated industries
.
Position Requirements
10+ Years
work experience
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