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Abbott · 3 hours ago

R&D Clinical Engineer

Menlo Park, CA

Full-time

Onsite

Mid Level

$82K/yr - $141K/yr

4+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking an R&D Clinical Engineer to define user needs and requirements, develop anatomical models, and perform verification and validation testing while collaborating with various cross-functional teams.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

Qualification

Medical product developmentClinical application understandingData analysisBiomedical engineeringRegulatory AffairsCommunicationProblem solvingLeadership capabilityOrganizational skills

Required

BS Degree in biomedical, mechanical, electrical, biological or physical science

Minimum of 4 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