Senior Design Assurance Engineer - Med Devices QA

Bracco Medical Technologies; Eden Prairie (MN); On-site; USD 112,000 - 120,000; Full time

Benefits offered by this job

Paid Time Off

Company Holidays & Paid Family Leave

Annual incentive plan

401k savings plan

Job summary

Bracco Medical Technologies in Minnesota is seeking a Sr. Design Assurance Engineer to support design verification/validation and maintain design control procedures for medical devices and SaMD products.

You will lead risk management, QA deliverables, and collaborate with development teams to ensure regulatory compliance. The role involves ensuring testability, traceability to requirements, and upholding ISO 13485 and FDA 21 CFR 820 standards across the product lifecycle.

Qualifications

• B.S. in Computer Science, Engineering (electrical or mechanical), or comparable science discipline.
• Minimum 5 years of Quality Engineering experience in medical device industry.
• Extensive knowledge of quality tools (Six Sigma, DOE, process analysis, FMEA, FTA).
• Extensive knowledge of ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820.
• Extensive knowledge of risk management and ISO14971.
• Ability to travel domestically and internationally.

Responsibilities

• Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements.
• Drive the Design Control process and develop the Design and Development File (DDF) within regulatory requirements.
• Ensure specifications are relevant, capable, and testable; verify through tests and documentation.
• Support design verification activities, assess protocols, and ensure test robustness and traceability.
• Own risk management activities from planning through verification and acceptance.
• Generate QA deliverables to meet project scope and plan.
• Review and approve project-related deliverables and change orders.
• Coordinate with external design/test organizations to fulfill Design Control requirements.

Skills

Quality Engineering

Risk management

Six Sigma

DOE

FMEA

FTA

ISO 13485

FDA 21 CFR 820

Communication skills

Project management

Travel

Education

B.S. in CS/Engineering

Job description

Bracco Medical Technologies in Minnesota is seeking a Sr. Design Assurance Engineer to support design verification/validation and maintain design control procedures for medical devices and SaMD products.

You will lead risk management, QA deliverables, and collaborate with development teams to ensure regulatory compliance. The role involves ensuring testability, traceability to requirements, and upholding ISO 13485 and FDA 21 CFR 820 standards across the product lifecycle.