Senior IVD Design & Reliability Engineer; Regulatory Focus
Job in
Bethesda, Montgomery County, Maryland, 20811, USA
Listed on 2026-09-06
Listing for:
Tunnell Government Services
Full Time
position Listed on 2026-09-06
Job specializations:
-
Engineering
Job Description & How to Apply Below
Tunnell Government Services seeks a senior engineering/regulatory leader to drive end-to-end IVD development, from concept through FDA clearance, under BARDA guidance. You will review technical and regulatory documents, provide expert opinions to government officials, and lead risk analysis, design controls and manufacturing considerations.
The role requires 15+ years in IVD and related fields, with strong knowledge of cGMP, ISO 13485, and regulatory filings.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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