Design Assurance Engineer II | Medical Device Quality

Abbott; Saint Paul (MN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

Health Savings Account

401(k)

Job summary

Abbott is seeking a Design Assurance Quality Engineer II to ensure new or modified medical device products meet requirements and quality system standards. The role supports development, manufacturing, and cross-functional teams to protect patient safety and align with business needs in the Vascular division.

You will lead Design Assurance deliverables, support risk management, and assist design verification/validation, process validation, and CAPA activities in a fast-paced, onsite setting at

Qualifications

• Bachelor’s degree in Engineering and 2+ years of engineering experience with quality tools/methodologies.
• Experience with design control, risk management, and regulatory compliance is required.
• Excellent communication and teamwork across matrixed, global teams.

Responsibilities

• Lead on-time completion of Design Assurance deliverables.
• Support definition of customer and product requirements.
• Lead risk management activities from concept through commercialization.

Skills

Quality tools/methodologies

Strong communication

Cross-functional collaboration

Problem solving

Adaptability

Education

Bachelor’s degree in Engineering

Advanced degree in Mechanical or Biomedical Engineering

Tools

CAPA process

Risk management tools

Job description

Abbott is seeking a Design Assurance Quality Engineer II to ensure new or modified medical device products meet requirements and quality system standards. The role supports development, manufacturing, and cross-functional teams to protect patient safety and align with business needs in the Vascular division.

You will lead Design Assurance deliverables, support risk management, and assist design verification/validation, process validation, and CAPA activities in a fast-paced, onsite setting at