Senior Medical Device Quality Engineer - R&D & Validation

Regulatory Jobs; Plymouth (MN); Sur place; USD 78 000 - 156 000; Plein temps

Avantages offerts par ce poste

HIP PPO medical coverage

Tuition reimbursement and FreeU

High employer retirement contribution

Résumé du poste

Abbott in Plymouth, MN, is seeking a Senior Engineer for the Electrophysiology (EP) division. You will contribute to development and sustaining activities for complex medical devices, leading verification/validation efforts and collaborating across functions to ensure design controls compliance.

The role emphasizes statistics, root-cause investigations, and regulatory readiness for FDA/ISO standards, with a base pay range of $78,000 to $156,000 annually. On-site position with some travel.

Qualifications

• Bachelor level degree in Engineering or Technical Field.
• Minimum of 6 years engineering experience with new product development.
• Working knowledge on design verification and design validation techniques.
• Working knowledge of applied statistics, sampling strategies, and DOE including Minitab.
• Strong organizational and follow-up skills with attention to detail.
• Ability to travel approximately 10%, including internationally.

Responsabilités

• Be a core team member to implement complex development projects including quality improvement initiatives.
• Set strategies for cross-functional teams and drive compliant, efficient solutions to complex problems.
• Train and develop other lower-level engineers.
• Execute holistic and strategic Design Verification/Validation strategies with emphasis on technical analysis, validation and verification.
• Lead design characterization activities for development projects.
• Influence design and verification decisions through applied statistics.

Connaissances

Design verification

Design validation

Statistical analysis

Minitab

Regulatory compliance

Cross-functional collaboration

Formation

Bachelor level degree in Engineering or Technical Field

Outils

Minitab

Description du poste

Abbott in Plymouth, MN, is seeking a Senior Engineer for the Electrophysiology (EP) division. You will contribute to development and sustaining activities for complex medical devices, leading verification/validation efforts and collaborating across functions to ensure design controls compliance.

The role emphasizes statistics, root-cause investigations, and regulatory readiness for FDA/ISO standards, with a base pay range of $78,000 to $156,000 annually. On-site position with some travel.