Senior R&D Clinical Engineer

Leading an active lifestyle is important to the many people we serve. Abbott’s Structural Heart division is a high growth business division working on MitraClip, TriClip Portfolios and novel Structural Heart therapies, allowing people to restore their health and get on with their lives.

Our location in Menlo Park, CA, currently has an opportunity for a Senior R&D Clinical Engineer.

We are seeking a Senior R&D Clinical Engineer with experience 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.

• →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.

• BS Degree in biomedical, mechanical, electrical, biological or physical science.
• Minimum of 6 years of relevant work 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.

• 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.