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Design Quality Engineer - Medical device
Job in
St. Cloud, Saint Cloud, Stearns County, Minnesota, 56301, USA
Listed on 2026-07-14
Listing for:
Intellectt Inc
Seasonal/Temporary
position Listed on 2026-07-14
Job specializations:
-
Engineering
Biomedical Engineer, Medical Device Industry, Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Title:
Design Quality Engineer - Medical device
Location:
Maple Grove, MN (Hybrid – 3 to 4 Days Onsite)
Duration: 12 Months Contract
Job SummaryWe are seeking an experienced Medical Device Design Assurance Engineer to support design assurance and quality activities for medical device products. The ideal candidate will have strong experience in Design Controls, Design Verification, Design History Files (DHF), Risk Management, and ISO standards within an FDA-regulated medical device environment.
Required Skills- 5–10 years of Medical Device Design Assurance experience
- Hands‑on experience with Design Controls
- Experience with Design Matrices and Engineering Prints
- Design History File (DHF) documentation
- Knowledge of ISO 14971 Risk Management
- Experience working in FDA-regulated medical device environments
- Cross‑functional collaboration with R&D, Quality, Regulatory, and Manufacturing teams
- Experience supporting audit readiness and regulatory compliance
- Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related field.
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