Senior Design Assurance Engineer — Medical Device QA Lead

Acist Medical Systems Inc.; Eden Prairie (MN); Hybrid; USD 112,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Company holidays

Paid family leave

Annual incentive plan

401(k) plan

Medical/dental/vision insurance

Employer HSA contributions

Employee assistance program

Tuition reimbursement

Job summary

Bracco Medical Technologies is seeking a Sr. Design Assurance Engineer to support design assurance activities for medical devices and SaMD products. You will guide quality characteristics, drive design control, and ensure regulatory compliance across the product lifecycle.

The role emphasizes verification/validation planning, test method validation, and change management, with collaboration across internal teams and external partners. Domestic/international travel is expected.

Qualifications

• Minimum B.S. in Computer Science, Engineering, or comparable science discipline.
• Minimum 5 years of Quality Engineering experience in medical device industry.
• Extensive knowledge of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, FTA).
• Extensive knowledge of ISO 13485 and FDA QSR 21 CFR 820.
• Extensive knowledge of risk management and ISO14971.
• Strong written and verbal communication skills.
• Ability to travel domestically and internationally.

Responsibilities

• Provide direction and technical expertise to product development teams on quality characteristics and conformance to requirements.
• Drive the Design Control process and develop the Design and Development File (DDF).
• Ensure requirements are testable, verifiable, and aligned with standards.
• Support design verification activities and assess test robustness and traceability.
• Own risk management from planning to acceptance for assigned areas.

Skills

Quality engineering

Regulatory compliance

Design control

Risk management

Communication

Travel willingness

Education

Bachelor's in CS/Engineering or related science

Advanced degree preferred

Tools

Six Sigma

DOE

FMEA

FTA

ISO 13485

FDA 21 CFR 820

Job description

Bracco Medical Technologies is seeking a Sr. Design Assurance Engineer to support design assurance activities for medical devices and SaMD products. You will guide quality characteristics, drive design control, and ensure regulatory compliance across the product lifecycle.

The role emphasizes verification/validation planning, test method validation, and change management, with collaboration across internal teams and external partners. Domestic/international travel is expected.