Design Assurance Engineer II

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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 a Design Assurance Engineer II based in Plymouth, MN, you will play a critical role in ensuring the safety, efficacy, and compliance of cutting-edge electrophysiology products. You will be providing development support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Controls with focus on ablation and diagnostic catheters. You will be a key contributor to the design, development and testing activities for complex medical devices.

• Lead and implement complex development projects including quality improvement initiatives.
• Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• 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
  • 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 communicating & resolving 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.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

• 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.
• ASQ certification (CQE, CQA) or similar is a plus. 

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