Senior Design Assurance Engineer – Med Device & SaMD

Bracco; Eden Prairie (MN); Sur place; USD 112 000 - 120 000; Plein temps

Résumé du poste

Bracco Medical Technologies is seeking a Sr. Design Assurance Engineer in Eden Prairie, MN. You will lead design assurance activities, support design verification/validation, and ensure conformity with ISO 13485 and FDA 21 CFR 820.

The role requires hands-on quality engineering across product lifecycles and collaboration with development teams. Responsibilities include developing test strategies, managing risk, and preparing regulatory documentation to support global submissions.

Qualifications

• BS in Computer Science, Engineering or related field required.
• Minimum 5 years of Quality Engineering experience in medical devices.
• Extensive knowledge of quality tools (Six Sigma, DOE, FMEA, FTA) and ISO 13485 / FDA 21 CFR 820.

Responsabilités

• Provide direction on quality characteristics and conformance to requirements for medical devices or SaMD.
• Drive Design Control and develop the Design and Development File (DDF) per regulatory standards.
• Lead risk management activities across planning, analysis, and verification.
• Prepare regulatory submission documentation and maintain traceability to requirements.

Connaissances

Quality Engineering

Regulatory knowledge

Risk management

Project management

Formation

B.S. in Computer Science, Engineering, or related field

Advanced degree preferred

Description du poste

Bracco Medical Technologies is seeking a Sr. Design Assurance Engineer in Eden Prairie, MN. You will lead design assurance activities, support design verification/validation, and ensure conformity with ISO 13485 and FDA 21 CFR 820.

The role requires hands-on quality engineering across product lifecycles and collaboration with development teams. Responsibilities include developing test strategies, managing risk, and preparing regulatory documentation to support global submissions.