Staff R&D Clinical Engineer

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 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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.

The Opportunity

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.

As the Staff R&D Clinical Engineer, you'll have the chance to define user needs and requirements, develop anatomical models and perform verification and validation testing. In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams, including Marketing, R&D, Risk Management, Medical Affairs, Quality and Regulatory Affairs. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques.

What You’ll Work On

• Owns pre-defined tasks within a larger effort such as user need and feature definition, validation or product development of a sub-system, and drives them to on-time, high quality completion.
• Investigates and defines clinical requirements for new product/feature development and facilitates the translation into new projects through clinical review and evaluation. Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features.
• Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications.
• Simulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyzes data collected from the field or from research studies.
• Develops and directs preclinical evaluation protocols, data analysis, and reports.
• Contributes to the evaluation and validation of a specific subsystem or project as necessary to conduct feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies.
• Provides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
• 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.

Required Qualifications

• BS Degree in biomedical, mechanical, electrical, biological or physical science.
• Minimum of 8 years of relevant work experience in medical product development and/or an equivalent combination of a graduate degree with relevant project experience.
• Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
• Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs.
• Strong analytical, problem solving skills.
• Demonstrated leadership capability in team settings.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communication ability.
• Meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.
• Ability to maintain regular and predictable attendance.

Preferred Qualifications

• Master’s or Doctoral Degree in biomedical, mechanical, electrical or biological or physical science or medicine.
• Advanced credential in a relevant discipline/concentration, including Biomedical Sciences, preferred.
• Medical device experience preferred.

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