R&D Clinical Engineering Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

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 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.

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.

We are seeking a R&D Clinical Engineering Manager with experience managing a team of engineers 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

• Manage clinical engineers to compete deliverables per define milestones.
• Define team and individual development plans, goals, and complete performance reviews; manage functional budget.
• 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