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Design Assurance Engineer II
Job in
Burlington, Chittenden County, Vermont, 05405, USA
Listed on 2026-06-05
Listing for:
Sci.bio Recruiting
Full Time
position Listed on 2026-06-05
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
We are seeking a Design Assurance Engineer II to serve as the key QA partner on product development projects from concept through manufacturing transfer. In this role, you will lead core Design Assurance activities, support risk management, and drive product improvements through cross-functional complaint investigations, metrics and data analysis, and CAPA management.
Job Responsibilities- Lead Design Assurance activities for new product development (risk management, V&V planning and execution, statistical analysis, design reviews, and R&D testing)
- Drive product improvements through cross-functional complaint investigations and root cause analysis
- Support complaint metrics and data visualization (Excel, Tableau)
- Manage and execute CAPAs
- Review document and design changes
Skills & Qualifications
- Minimum of 3-5 years of experience in design assurance/engineering roles within the medical device industry.
- Experience with risk management methodologies (e.g., FMEA, fault tree analysis) and risk management tools.
- Comfortable with basic statistics and data analysis
- Knowledge of FDA regulations and ISO 13485 standards for medical devices
- Experience with project management is a plus
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