Senior R&D Clinical Engineer

Abbott•Menlo Park, CA

2d•$90,000 - $180,000•Onsite

About The Position

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. This position works out of our Menlo Park, CA location 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 R&D 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.

Requirements

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.
Experience working within quality system catered to medical device design controls.
Possesses excellent verbal and written communication skills, with ability to communicate to all levels of the organization.

Nice To Haves

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 varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs.
Previous experience working in a highly matrixed and geographically diverse business environment.
Experience in Human Factor Engineering.
Knowledge of statistical techniques and design of experiments.

Responsibilities

Gathers, understands, and analyzes input requirements from stakeholders for new medical devices while supporting the instrumentation/service infrastructure.
Translates information into specific system features.
Synthesizes all gathered information together with technical and regulatory constraints in order to define a system and its behavior resulting in defining a system specification.
Assists in determining clinical priorities for new products.
Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyzes system integration issues, generates initial baseline interface specifications, estimates costs and risk, and evaluates customer satisfaction through end user testing (simulated use, pre-clinical, and/ or usability), analysis and studies.
Provides clinical, usability and system level technical guidance and leadership to teams as appropriate.
Evaluates 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 requirements.
Evaluates the system user interface (device controls, IFU, training, etc.) formally and informally through structured and ad hoc testing.
Test aspects of the system user interface to evaluate prototype usability with end users and validate user interface is safe and effective.
Provides input into the development of clinical system validation plans and the conduct of those tests.
Identifies and resolves issues, escalating as appropriate.
Supports 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.

Benefits

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.

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