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Senior Clinical Engineer

Senior Clinical Engineer

The Job Responsibilities


The Sr. Clinical Engineer plays a critical role in product design and development by contributing to the definition, development and validation of multi-parameter patient monitor and system solutions. Serves as clinical application subject matter expert that will work with clinical end users and Key Opinion Leaders to gain understanding of clinical requirements and workflows and translate to development teams. Responsible for managing and executing clinical evaluations (including alpha/beta testing) and clinical trials. Develops technical documentation including study protocols/reports, clinical implementation guides, Clinical Evaluation Plans and Reports, and PMCF Plans and Report. Works closely with Risk Management, Product Management, UI Designers, Engineering, Post Market Surveillance, Product Qualification, Quality and Regulatory.

Serves as the clinical engineering representative on a product cross functional team responsible for planning and executing project deliverables according to the project plan

Supports the definition of design inputs including Customer/User Requirements, Technical System Requirements, and User Interface Specifications for patient monitoring and system products

Participates in the product risk analysis to identify clinical risks, including usability hazards that may result due to normal use, reasonably foreseeable misuse, or abnormal use in collaboration with the risk manager and other engineering disciplines in accordance with internal processes and standards (ISO 14971)

Develops, maintains and expands collaborations with clinical experts to gain understanding of clinical needs, product opportunities, and technology direction to translate to product development teams

Overall responsibility for validation testing and clinical trials including planning, preparing test protocols, managing test sites, gathering clinical data, performing data analysis, and generating summary reports

Works with Human Factors Engineers on usability evaluation activities in conformance with current standards (IEC 62366, ANSI HE75, ISO 14971), and FDA guidance

Generates and maintains clinical documents including Clinical Evaluation Plans and Reports using literature techniques and clinical data analysis, including evaluating post-market data, and PMCF Plans and Reports

Performs other duties as assigned

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