Design Assurance Engineer II - Medical Devices

Abbott; Plymouth (MN); On-site; USD 61,300 - 122,700; Full time

Job summary

Abbott in Plymouth, MN seeks a Design Assurance Engineer II to lead development projects and ensure design verification/validation for medical devices. The role requires coordinating cross‑functional teams and aligning outputs to regulatory expectations and production controls.

Responsibilities include establishing verification strategies, leveraging statistics, and supporting audits and re‑certifications while maintaining DHF integrity and compliance with FDA regulations.

Qualifications

• Bachelor’s degree in Engineering or a Technical Field; advanced degree preferred.
• Experience with design verification/validation in medical devices.
• Familiarity with regulatory standards (FDA, GMP, ISO 13485).
• Knowledge of statistical methods and software (Minitab).
• Ability to travel up to 5–10%, including international.

Responsibilities

• Lead complex development projects and quality improvement initiatives.
• Set cross‑functional strategies and drive compliant, efficient solutions.
• Develop and execute design verification/validation strategies with emphasis on controls.

Skills

Design verification

Design validation

Applied statistics

Minitab

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in engineering or technical field

Advanced degree in Biomedical/Mechanical Engineering preferred

Tools

FDA/ISO standards knowledge

Job description

Abbott in Plymouth, MN seeks a Design Assurance Engineer II to lead development projects and ensure design verification/validation for medical devices. The role requires coordinating cross‑functional teams and aligning outputs to regulatory expectations and production controls.

Responsibilities include establishing verification strategies, leveraging statistics, and supporting audits and re‑certifications while maintaining DHF integrity and compliance with FDA regulations.