Design Assurance Engineer II

About the role

The opportunity exists within Abbott's Electrophysiology (EP) business, focusing on the advancement of heart disease treatments through innovative medical technologies, particularly in atrial fibrillation.

Responsibilities

• Lead and implement complex development projects including quality improvement initiatives.
• Set strategies for cross-functional teams and drive towards compliant and efficient solutions to complex problems.
• Execute on holistic and strategic design verification/validation strategies with emphasis on:
• Technical analysis of requirements, specifications, and control strategy
• Efficient and cost-effective execution of validation and verification
• Alignment of design outputs to production and process controls
• Proper verification techniques including inspection, demonstration, test, etc.
• Lead design characterization activities for development projects.
• Influence design and verification decisions through use of applied statistics.
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicate & resolve gaps.
• Support and ensure internal & external audit responses and on-time product re-certifications.
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

Requirements

• Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Mechanical Engineering preferred.
• 2-3 years Engineering experience with new product development.
• Strong 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.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to collaborate on-site on a regular basis.
• Ability to travel up to 5-10%, including internationally.
• Knowledge of FDA, GMP, ISO 13485, IEC 60601, ISO 14971.
• Prior medical device experience, especially electrophysiology or cardiovascular devices preferred.
• AQS certification (CQE, CQA) or similar is a plus.