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Abbott · 21 hours ago

Senior Clinical Engineer

United States - California - Menlo Park

Full-time

Onsite

Mid, Senior Level

4+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Clinical Engineer supports product development efforts by leading systems and clinical engineering tasks, defining, developing, or validating features on major programs.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

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

Qualification

Biomedical EngineeringClinical EngineeringMedical Device ExperienceHuman Factor EngineeringStatistical TechniquesVerbal CommunicationWritten CommunicationTeam Collaboration

Required

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

Preferred

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