Design Assurance Engineer II

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the Design Assurance Engineer II, you’ll represent Design Assurance on electrophysiology catheter and disposable sustaining engineering projects.

This role is responsible for maintaining a strong collaborative partnership with cross-functional engineering teams to ensure that devices are developed and maintained in accordance with product requirements, and that they meet their intended use delivering the safest experience possible to our patients.

This role will review requirements, specifications, and technical design documents to provide timely feedback aimed at improving product quality, safety, reliability, and manufacturability to sustaining engineering teams.

What You’ll Work On

Execute on Holistic & 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

Maintain DHF, design input / design output, external requirements, and risk management documentation.

Lead risk management meetings assessing the impact of product or supplier changes to risk profile.

Execute design verification and validation activities including test planning and execution, and creation of protocols and reports.

Interpret external standards and implement product requirements and testing to meet external standards.

Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps.

Support design, test, inspection method development, and lead method validation activities

Participate in root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.

Present to the manager level on significant matters

Serve as a back-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance.

Ability to work both within a team, and independently, in a geographically diverse business environment.

Strong verbal and written communications with effective communication at multiple levels in the organization

Perform other duties and responsibilities as assigned by functional management based on the current project / business objectives including 10% travel, including international travel and regular predictable attendance.

Required Qualifications

Bachelor level degree in an Engineering or Science.

1.5+ years’ experience.

Strong technical writing skills.

Experience with root cause identification and problem solving.

Preferred Qualifications

Degree in Material Science, Mechanical, Biomedical, Electrical, or Chemical Engineering.

Engineering experience and demonstrated use of Quality tools / methodologies.

Knowledge of FDA, GMP, ISO 13485, and ISO 14971.

Prior medical device experience.