Senior Development Quality Engineer — Medical Device, Design Verification

Abbott Laboratories; Plymouth (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is seeking a Senior Engineer to join the Electrophysiology division in Plymouth, MN. You will provide development and sustaining support on complex medical devices, leading design verification/validation activities and cross-functional collaboration.

The role emphasizes statistical analysis, regulatory compliance, and mentoring of junior engineers within a multidisciplinary team, with travel as needed and on-site collaboration.

Qualifications

• Bachelor-level degree in engineering or technical field.
• Minimum of 6 years engineering experience in new product development.
• Knowledge of design verification and design validation techniques.
• Applied statistics and design of experiments; familiarity with Minitab.
• Strong organizational skills and attention to detail.
• Willingness to travel ~10%, including international.
• Knowledge of FDA, IEC 60601, GMP, ISO 13485, ISO 14971.
• Medical device experience preferred.

Responsibilities

• Lead complex development projects and quality improvement initiatives.
• Set strategies for cross-functional teams and drive compliant solutions.
• Train and develop junior engineers.
• Execute holistic design verification/validation strategies with focus on requirements analysis, validation, and verification.
• Lead design characterization activities and influence verification decisions.
• Support and lead method validation and inspection method development.

Skills

Design verification

Design validation

Applied statistics

On-site collaboration

Regulatory awareness

Education

Bachelor degree in Engineering or Technical Field

Tools

Minitab

Job description

Abbott is seeking a Senior Engineer to join the Electrophysiology division in Plymouth, MN. You will provide development and sustaining support on complex medical devices, leading design verification/validation activities and cross-functional collaboration.

The role emphasizes statistical analysis, regulatory compliance, and mentoring of junior engineers within a multidisciplinary team, with travel as needed and on-site collaboration.