Senior Project Engineer

3 weeks ago

Subang Jaya, Selangor, Malaysia ECRI Full time

ECRI is a non-profit organization dedicated to advancing cost-effective, safe, quality healthcare across the continuum of care. We fulfill our mission through independent research on healthcare technologies and patient safety, providing access to our extensive database, customized consultation, and delivery of specialized training programs.

Summary

To evaluate and develop key specifications for medical devices, provide technical consultation to the healthcare community on general health device topics and to apply broad judgment and experience to Device Evaluation activities. To participate in diverse ways, such as helping to plan new programs, sharing knowledge, and assisting in ongoing projects.

Responsibilities

General

  • Provide logically structured report drafts based on Device Evaluation Group templates.
  • Present and discuss research findings to ECRI staff.
  • Document all research results, internal reviews, and member consultations as defined in Device Evaluation Group Quality documentation.
  • Manage assigned projects to meet scheduled deadlines and update supervisors on projects and problems on a regular basis.
  • Present and discuss research findings in a variety of formats, including written, graphical, and video.
  • As assigned, may assume leadership of major projects, and coordinate these activities with Device Evaluation Group Management.

Product Evaluation for Publication

  • Perform preliminary research leading to the development of evaluation criteria and test protocol, which will be used to determine the extent to which devices under evaluation meet clinical needs.
  • Perform vendor scouting and establish contacts with device manufacturers to obtain information on devices and obtain test samples.
  • Establish contacts with device users to obtain insight into medical technologies.
  • Conduct appropriate laboratory, clinical, or field tests according to the test protocol.
  • Prepare a preliminary draft of an article to guide hospital personnel on the selection, use, and maintenance of the device under evaluation.
  • Provide draft reports to be reviewed by ECRI personnel, outside experts, and manufacturers, and incorporate appropriate changes.
  • Participate in the development of project schedules.
  • Manage projects to meet scheduled deadlines.

Development of Key Specifications Pertinent for the Selection of Medical Devices and Supplies

  • Perform preliminary research to develop project scope.
  • Identify key product attributes and how they contribute to purchasing decisions.
  • Review data for quality and deliver data for publication.

Development of Additional Material for Publication

  • Device inspection and preventive maintenance procedures for clinical engineering personnel.
  • Determine key specifications pertinent for the selection of medical devices.
  • Instructional articles for clinical personnel on equipment use and technology.
  • Prompt evaluation of Problem Reports and development of Hazard Reports or User Experience Network Articles with recommendations for corrective measures.
  • Special articles on topics such as equipment control, technology assessment, and codes and standards.

Consultation and Investigation

  • Review reports, abstracts, and drafts according to expertise.
  • Provide telephone and written consultation replies to personnel at member facilities.
  • Perform comparative testing and analysis of medical products, including development and completing laboratory tests, literature review, and providing final report for customers.
  • Assist other ECRI personnel by providing information in areas of specialized experience or knowledge.
  • Provide contract services to healthcare facilities for equipment planning acquisition and management projects, or other topics, usually including site visits to the facility and preparation of a final report with conclusions.
  • Perform and assist with accident or forensic engineering investigations involving healthcare technology incidents associated with actual or potential threats to the life or safety of patients or personnel.
  • Critically review technical materials from outside sources (e.g., project proposals, journal articles, standards, reports) for engineering and scientific soundness.
  • Provide feedback to internal authors on the quality, clarity, and accuracy of their research.
  • Identify potential issues with the research methodology or conclusions.
  • Suggest improvements to the manuscript to enhance its publication potential.
  • Collaborate with co-authors to finalize manuscripts for submission to ECRI systems.

Community Education and Training

  • Responsible for training new employees, interns, and students in various issues of healthcare technology or ECRI processes.
  • Assist in developing and maintaining policies, objectives, and means to ensure the scientific validity of the work, group efficiency, and timely, marketable, and competitive products.
  • Prepare and present seminars on selected topics for seminar series, training programs, and special healthcare facility requests.
  • Interact with other organizations to the benefit of ECRI and the community.
  • Provide technical guidance and evaluation support to other ECRI colleagues.

Administrative

  • Assist in supervising the day-to-day operation of the IRC team.
  • Maintain complete records for all assigned projects, including meticulous electronic documentation of test methods and data in project files.
  • Read relevant technical journals and literature related to activities and maintain information files on designated topics.
  • Participate in recruiting and applicant interviewing processes.
  • Update supervisors on projects and problems on a regular basis.
  • Maintain an effective personal filing system and observe institutional filing procedures.
  • Review reports, abstracts, and drafts according to expertise.
  • Other duties as assigned.

Requirements

  • Bachelor's Degree Required, in biomedical and/or electrical engineering. Master's Degree in biomedical and/or electrical engineering preferred.
  • Minimum 8 years' work experience in clinical science, engineering or related discipline.
  • Ability to communicate effectively and concisely both orally and in writing.
  • Proven track record of dependable, reliable, and thorough performance and ability to manage changing priorities for multiple simultaneous tasks.
  • Proficient with Microsoft Office 365 Suite of products (e.g., Word, Excel, and PowerPoint).
  • Demonstrate independent thinking with a clear, logical line of reasoning; issues must be well thought out and clearly presented.
  • Demonstrate strong problem-solving abilities with good engineering/scientific judgment.
  • Recognize areas of concern and/or controversy and bring these to the attention of appropriate ECRI staff with recommended solutions.
  • Remain current with technological and regulatory developments within fields of major medical experience and interest.
  • Innovation and creativity are expected in developing effective, timely, and economical methods to complete assignments.
  • Ability to participate in and manage multiple simultaneous activities in an effective manner is expected.
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