Senior Medical Device Quality Engineer: Design & Validation

Thornton Tomasetti; Plymouth (MN); Hybrid; USD 78,000 - 156,000; Full time

Job summary

Abbott Laboratories in Plymouth, MN is seeking a Senior Development Quality Engineer to lead development and sustaining activities for complex medical devices within the Electrophysiology group. You will guide design verification and validation efforts, apply statistics, and influence cross-functional teams to ensure compliant, robust products.

The role requires on-site collaboration, approximately 10% travel including international, and close liaison with regulators such as FDA and ISO

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 design of experiments, including statistical software tools such as Minitab.

Responsibilities

• Be a core team member to implement complex development projects including quality improvement initiatives.
• Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Train and develop other lower-level engineers.
• Lead design verification/validation activities with emphasis on technical analysis of requirements, specifications, and control strategy.
• Lead root cause investigations, including corrective and preventive actions.

Skills

Applied statistics

Design verification

Design validation

Design of experiments

Education

Bachelor degree in Engineering or Technical Field

Tools

Minitab

Job description

Abbott Laboratories in Plymouth, MN is seeking a Senior Development Quality Engineer to lead development and sustaining activities for complex medical devices within the Electrophysiology group. You will guide design verification and validation efforts, apply statistics, and influence cross-functional teams to ensure compliant, robust products.

The role requires on-site collaboration, approximately 10% travel including international, and close liaison with regulators such as FDA and ISO