Design Assurance Engineer

Virtual Vocations Inc

United States

United States

Über

Leading product development and ensuring compliance with design controls, the full-time remote Design Assurance Engineer will manage the creation and maintenance of design history files, oversee design verification and validation studies, and support regulatory submissions while collaborating with contract manufacturers. Key responsibilities
Lead product development and implement design controls for new products and changes Create and maintain design history files and related specifications Perform lot release and support post-market surveillance activities
Required qualifications
Bachelor's degree in life sciences, material sciences, engineering, or a related field Minimum 3 years of experience in the medical device industry Working knowledge of design controls and ISO 13485 standards Experience in a small company or start-up environment preferred Familiarity with QMS support software/document control systems is a plus

United States

Sprachkenntnisse

English

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