Design Assurance Engineer II

Abbott • Plymouth, MN

3d • $61,300 - $122,700 • Onsite

About The Position

This position works out of our Plymouth, MN location in the Electrophysiology division. 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 an Engineer II, you will be providing development and sustaining support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Production/Process Controls with a focus in the disposable catheter. You will be a key contributor to the design, development and testing activities for complex medical devices.

Requirements

• Bachelor level degree in Engineering or Technical Field
• Minimum of 3 years engineering experience with new product development
• Minimum of 3 years quality engineering experience supporting disposable ablation catheter production
• Minimum of 3 years experience owning NCMRs, CAPAs, Stop Ships, and HHEs
• Working knowledge on design/process verification and design/process 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 approximately 10%, including internationally.

Nice To Haves

• Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971
• Prior medical device experience preferred.

Responsibilities

• Be a core team member to implement complex development projects including quality improvement initiatives.
• Cross-functional team member and driving towards compliant and efficient solutions to complex problems.
• Execute on Holistic & Strategic Design Verification/Validation, Process Verificaiton/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.
• Support design and process characterization activities for development projects
• Apply statistics to design/process and verification decisions.
• Support design/process test and inspection method development, and lead method validation activities.
• Lead root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.
• Ensure DHF, DMR, DHR content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps.
• Participate in internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level