Sr Clinical Engineer - Draeger Medical Systems, Inc. - Job-ID V000002708

  • Draeger,
  • Andover, MA
  • 11 hours ago
Engineer, Risk Management, Management, Engineering, Surveillance, Quality, System, User Interface, ISO, Engineers, ANSI, FDA
Full Time
Work from home not available Travel not required

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 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

Who you are
BS in engineering (biomedical or related), biosciences and/or nursing required; Master's degree preferred

Minimum 5 years' experience in the medical device industry with relevant work experience including clinical/user 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 and/or reviewing clinical documents required for EU MDD/MDR, including Clinical Evaluation Plans/Reports is preferred

Experience conducting clinical studies

Understanding of relevant regulations for clinical trials including ICH guidelines, GCP, FDA and applicable international regulations and practices

Knowledge of US and international regulations for medical device manufacturers, including EU MDD/MDR as it relates to clinical evaluation

International and domestic travel required (less than 20%)

Internal code #LI-MC1 *mon*
Dice Id : RTX123184
Position Id : J000005487
Originally Posted : 2 months ago
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