Senior Design Assurance Engineer Medical Devices; ISO/FDA
Job in
Plymouth, Hennepin County, Minnesota, USA
Listed on 2026-07-14
Listing for:
Novozen Healthcare LLC
Full Time
position Listed on 2026-07-14
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Novozen Healthcare LLC seeks a Senior Design Assurance Engineer to lead quality engineering for design controls, DHFs, and risk management across the product lifecycle. This role guides ISO remediation, FDA QSR/ISO 13485 compliance, and collaboration with Engineering, Regulatory, and Manufacturing to drive inspections readiness and continuous improvement.
The ideal candidate has 10+ years in medical device Design Assurance or Quality Engineering, strong leadership, and hands-on experience with
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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