Sr Clinical Engineer - Draeger Medical Systems, Inc. - Job-ID V000004266

Company: Draeger
Location: Lynn
Posted on: November 19, 2020

Job Description:

What will you do 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 alphabeta testing) and clinical trials. Develops technical documentation including study protocolsreports, 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 CustomerUser 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 Who you are BS in engineering (biomedical or related), biosciences andor nursing required Master's degree preferred Minimum 5 years' experience in the medical device industry with relevant work experience including clinicaluser research, product validation, clinical studies 2 to 3 years if previously practiced as a nurse or clinician Experience developing medical device products in regulated industry, patient monitoring experience preferred Experience as a nurse, clinician, or clinical engineer in hospital environment is preferred Demonstrated experience in product validation Experience writing andor reviewing clinical documents required for EU MDDMDR, including Clinical Evaluation PlansReports is preferred Experience conducting clinical studies Understanding of relevant regulations for clinical trials including ICH guidelines, Google Cloud Platform, FDA and applicable international regulations and practices Knowledge of US and international regulations for medical device manufacturers, including EU MDDMDR as it relates to clinical evaluation International and domestic travel required (less than 20) Internal code LI-MC1 mon

Keywords: Draeger, Lynn , Sr Clinical Engineer - Draeger Medical Systems, Inc. - Job-ID V000004266, Other , Lynn, Massachusetts