Senior Engineer, Design Assurance

About the role

The Senior Engineer, Design Assurance is responsible for providing critical quality engineering support throughout the product lifecycle, ensuring medical device designs remain safe, effective, compliant, and aligned with user needs and business objectives.

What you'll do

• Responsible for providing critical quality engineering support throughout the product lifecycle, ensuring medical device designs remain safe, effective, compliant
• Manage and maintain the Design History File (DHF)
• Perform routine DHF audits to ensure continuous compliance
• Review and approve design requirements (PDR/Requirements Matrix) and design changes (Change Orders) to ensure appropriate validation and verification (V&V) requirements…
• Collaborate cross-functionally to create and maintain risk management files and documents

What you need

• 3–6 yrs of experience
• Risk management
• Compliance
• GD&T
• Six Sigma
• Audit
• FMEA
• B.Tech or B.E.

Good to have

• Root cause analysis