Principal Project Officer I

at  ECRI

WHY CHOOSE ECRI?

ECRI is an inspiring place to work. We share a common mission to help healthcare organizations make smart, compassionate, and ethical decisions for patients. Consider these additional benefits of joining the ECRI team:

• Industry leadership: We have a long history and proven reputation in patient safety and medical technology research.
• On-the-job-learning: You will have the opportunity to work with specialists across medical science, patient care, healthcare management, and technology.
• Comprehensive healthcare benefits: We offer medical, dental, vision, life insurance, accidental death and dismemberment, and disability coverage.
• Retirement Savings: Our employees can participate in an employer-matching 403(b) Retirement Savings Plan.
• Additional benefits: ECRI offers additional benefits to our employees, including paid time off and holiday pay, paid leave for parents, tuition assistance, employee assistance program, access to LinkedIn Learning, and other voluntary benefit programs (e.g. accident insurance, identify theft insurance, flexible spending accounts).
• Volunteer Program: ECRI Cares, our employee volunteer program, provides a framework for us to work together and make a difference in the lives of others. All employees are provided 16 hours annually of paid time to volunteer at preapproved ECRI Cares charities during normal business hours.

POSITION SUMMARY

To evaluate cybersecurity and interconnectivity of medical devices, provide technical consultation and risk assessment to the healthcare community, apply broad judgment and experience to multiple Device Safety activities. To participate in diverse ways, such as helping to plan new programs, selecting and training staff, and assisting in managing ongoing internal and external projects. To serve as a key information security expert within the Device Safety team.

EXPERIENCE:

• 10 years work experience in a clinical setting or in a relevant technical field.
• Experience with NIST cybersecurity framework, or similar framework, required.
• Experience with medical device manufacturer disclosure statements for medical device security preferred.
• Ability to communicate very effectively and concisely both orally and in writing.
• Must have proven track record of dependable, reliable, and thorough performance and be able to manage changing priorities for multiple simultaneous tasks.

EDUCATION:

• Bachelors degree required, preferably in computer or biomedical engineering, information security, or a related clinical science field. Masters or doctoral degree preferred, preferably in computer or biomedical engineering, information security, or a related clinical science field.

COMPUTER SKILLS:

• Proficient with Microsoft Office 365 Suite of products (e.g., Word, Excel, and PowerPoint).

Community Education:

• Presents externally to regulators, accreditors, providers, media outlets, and other healthcare stakeholders.
• Prepares and presents seminars on selected topics for seminar series, training programs, and special healthcare facility requests.
• Provides training and assistance to Device Safety staff.
• Interacts with other professional organizations to the benefit of ECRI and the community

ESSENTIAL FUNCTIONS STATEMENT(S):

General:

• Must be a leader who thinks strategically and has the long-range goal of excellence of Device Safety initiatives.
• Must remain current with technological and regulatory developments within fields of major experience and interest serving as an expert in those fields.
• Must be able to conduct all projects and responsibilities with minimal supervision and at a senior level.
• Ability to manage and ensure modern ECRI laboratory network infrastructure with ECRI IT to enable Device Safety information security initiatives is expected.
• Manages assigned projects to meet scheduled deadlines and updates supervisors on projects and problems on a regular basis.
• Ability to participate in and manage multiple simultaneous activities in an effective, timely, and economic manner is expected.
• Internally and externally present and discuss research findings in a variety of formats, including written, graphical, oral, and video.
• As assigned, assume leadership of major projects, including supervision of assigned personnel, and coordinate these activities with Device Safety Leadership. Such assignments will be based on the organization’s needs, and the individual’s aptitude and performance.
• Must demonstrate independent thinking with a clear, logical line of reasoning; issues must be well thought out and clearly presented.
• Must demonstrate strong problem-solving abilities with excellent and reasoned engineering/scientific judgment.
• Must recognize areas of concern and/or controversy, or in potential violation of ECRIs Code of Ethics, and bring these to the attention of appropriate ECRI staff with recommended solutions.

Consultation:

• Develop and execute security risk assessment services programs for healthcare facilities, including site visits to the facility and preparation of a final report with conclusions, and presentation to facility leadership.
• Supervise information security contractors in various activities related to penetration testing, security hazard and risk assessment, and other areas of healthcare consulting or product evaluation.
• Reviews internal reports, abstracts, and drafts according to expertise.
• Provides verbal and written consultation to internal and external customers.
• Responsible for comparative testing and analysis of medical products, including development and completing laboratory tests, literature review, and providing final report for customers.
• Critically reviews technical materials from outside sources (e.g., project proposals, journal articles, standards, reports) for engineering and scientific soundness.
• Expected to increase ECRIs reach in improving healthcare via new businesses or relationships such as setting up new business lines or consulting relationships, leading ECRI into new lines of scientific inquiry, planning and completing large complex evaluations.

Product Evaluation and Guidance:

• Performs product evaluations of network security and connectivity for medical devices at a senior level.
• Develops evaluation criteria and test protocols, to meet customer and clinical needs.
• Establishes contacts with device and technology manufacturers to obtain information on devices and obtain test samples.
• Establishes contacts with device and technology users to obtain insight into medical technologies.
• Conducts and/or supervises appropriate laboratory, clinical, or field tests according to the ECRI protocol.
• Prepare a well-organized article to guide hospital personnel on the selection, use, and maintenance of the device or technology under evaluation.
• Assure drafts are reviewed by ECRI personnel, outside consultants, and manufacturers and incorporate appropriate changes. Areas of concern and/or controversy, along with recommended solutions, should be recognized and brought to the attention of appropriate ECRI staff.
• Have direct responsibility for ensuring that evaluation work meets ECRI quality requirements.
• Instructional articles for clinical personnel on equipment use and technology.
• Instructional articles on guidance for existing and emerging cybersecurity threats to patient safety.
• 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.

Community Education:

• Presents externally to regulators, accreditors, providers, media outlets, and other healthcare stakeholders.
• Prepares and presents seminars on selected topics for seminar series, training programs, and special healthcare facility requests.
• Provides training and assistance to Device Safety staff.
• Interacts with other professional organizations to the benefit of ECRI and the community.

Administrative:

• Maintains complete records for all assigned projects, including meticulous electronic documentation of test methods and data in project files.
• Reads relevant technical journals and literature related to activities and maintains information files on designated topics.
• Participates in recruiting and applicant interviewing processes.
• Maintains an effective personal filing system and observes institutional filing procedures.