Design Assurance Engineer

Job Summary

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