Senior Clinical Engineer

Job Description Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and Lexus 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 a great place to work for diversity, working mothers, female executives, and scientists.

This position can work out of our Menlo Park, CA or Plymouth, MN locations in the SH division.

Structural Heart Business Mission:
Why We Exist.

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

The Senior Clinical Engineer supports product development efforts as a key member of program teams by leading systems and clinical engineering tasks, defining, developing or validating a smaller program or several features on a major program.

• Gather, understand, and analyze input requirements from stakeholders for new medical devices while supporting the instrumentation/service infrastructure. Translate information into specific system features.
• Synthesize all gathered information together with technical and regulatory constraints in order to define a system and its behavior, resulting in a system specification.
• Assist in determining clinical priorities for new products.
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• Perform technical planning and performance evaluation studies, conduct technology assessment activities, analyze system integration issues, generate initial baseline interface specifications, estimate costs and risk, and evaluate customer satisfaction through end user testing (simulated use, pre‑clinical, and/or usability).
• Provide clinical, usability and system level technical guidance and leadership to teams as appropriate.
• Evaluate prototypes formally and informally through structured and ad‑hoc testing. Test aspects of new projects or sub‑systems to evaluate prototypes and validate output to meet intended use.
• Evaluate the system user interface (device tháng, spectac, training, etc.) formally and informally through structured and ad‑hoc testing. Test aspects to evaluate prototype usability with end users and validate that the user interface is safe and effective.
• Provide input into the development of clinical system validation plans and the conduct of those tests.
• Identify and resolve issues, escalating as appropriate.
• 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.

• Bachelor’s degree in Biomedical, Electrical, or Systems Engineering or related science.
• 4+ years of experience in a clinical engineering role.
• Experience working within a team and as an individual contributor in a fast‑paced, changing environment.
• Possesses excellent verbal and written communication skills, with ability to communicate to all levels of the organization.

• Medical device experience.
• Master’s Degree in Biomedical, Electrical, or Systems Engineering or equivalent.
• Possesses baseline clinical knowledge of cardiac function.
• Demonstrated ability to effectively integrate information from…