The Health System Specialist for X_labs, is responsible for leading, coordinating, and facilitating all clinical aspects of medical device design, development, testing and manufacturing. X_labs is a new service line at VA Puget Sound, working under the national direction of the VHA Office of Healthcare Innovation and Learning (OHIL).
To qualify for this position, applicants must meet all requirements within 30 days of the closing date of this announcement. Individual Occupational Requirement: This position has an Individual Occupational Requirement. An Individual Occupational Requirement is a basic requirement for this position. All applicants, regardless of grade level, must meet minimum education requirements. For this occupation, the education must be accredited by an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. Applicants must meet one of the following requirements: A bachelor's or graduate/higher level degree in hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. NOTE: TRANSCRIPTS REQUIRED: If claiming education as qualifying for the Individual Occupational Requirement transcripts (unofficial or official) must be submitted with your application materials. Education cannot be credited without documentation. OR Progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field. This work may have been performed in an operating health care facility or a higher organizational echelon with advisory or directional authority over such facilities. Work must have involved a close working relationship with facility managers and analysis and/or coordination of administrative, clinical, or other service activities, and provided knowledge of the following: Missions, organizations, programs, and requirements of health care delivery systems; Regulations and standards of various regulatory and credentialing groups; and Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement. OR Successful completion of an agency-sponsored on-the-job training program may be substituted for qualifying experience, provided it included a formal individualized training plan. Such a training program must have been conducted in an operating health care system and included: Assignments providing a knowledge of basic health system administration philosophies, practices, and procedures, and basic government administrative policies and requirements; Practical assignments providing an opportunity to apply health system administration skills and principles (as the individual progresses, work assignments must be characteristic of the grade level to which he or she is assigned); and Oversight by an experienced health system administrator with periodic evaluation of the individual's progress and appropriate adjustment of the training program. AND GS-13 grade level: One year of specialized experience (equivalent to the GS-12 grade level in the federal service); experience that equipped the applicant with the particular knowledge, skills and abilities (KSA's) and other characteristics to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled, in the normal line of progression for the occupation in the organization. Specialized experience includes: lead, coordinate, and facilitate all clinical aspects of medical device design, development, testing and manufacturing; review and on-board new clinical and practical applications for 3D Printing at designated advance manufacturing sites coordinate, create and ensure implementation of safety checklists for all new advanced manufacturing technology; identify, categorize, analyze, and apply qualitative/quantitative data methods for assessment and improvement of program effectiveness, to design and conduct studies, and propose solutions to management; provide recommendations for improvements to meet program objectives. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Strong understanding of patient anatomy, surgical and interventional approaches, and potential complications that might impact the safety and efficacy of devices and processes. Mastery of clinical and operational vocabulary, taking into consideration differences across different VHA hospitals to provide a unified language that enables the Office of Advanced Manufacturing (OAM) to collaborate seamlessly across the enterprise. Able to clearly communicate engineering and regulatory principles in a manner understandable by clinical staff. Familiar with digital clinical planning tools (e.g., image segmentation software and computer assisted design software) and technologies in radiology, surgery, interventional cardiology, and other departments which facilitate better patient outcomes. Familiar with common and rare cardiac procedures, including transcatheter aortic valve replacement (TAVR), left atrial appendage occlusion (LAAO), mitral valve repair. Sufficient knowledge of medical products, manufacturing processes, design, and research to effectively communicate requirements to technical design teams and provide in-person, hands-on training to a wide variety of VHA staff traveling to X_labs for destination learning. Experience working directly with surgeons to develop image based, patient specific 3D printed medical devices. Experience developing and testing medical devices, as well as training physicians from across the country using cadavers. Develop products within the VA Quality Management System and works to continuously improve the QMS, this includes documenting the development and manufacturing processes. Collaborate with quality engineers, manufacturing engineers, regulatory advisors, technicians, clinicians, and more to develop medical devices. Develop and manufacture life-cycle for at least one Class II or higher, FDA regulated medical device, under the oversight of a 21 CFR 801/820/821/822 compliant Quality System operating within the walls of a hospital system. Manage material selection, sourcing, quarantine, verification, traceability, and disposal for additive manufacturing materials for the production and post-processing of medical devices. Including experience with testing and evaluation per ISO 10993 for assessing the irritation potential of medical devices, materials or their extracts. Perform other duties as assigned. Work Schedule: Monday through Friday; hours negotiable (7:00 AM- 5:00 PM PDT). Position Description Title/PD#: Health System Specialist/PD414950 Physical Requirements: The work requires some physical exertion such as long periods of standing, or recurring and considerable crouching, bending, standing, stooping, stretching, or walking such as in performing regular and recurring medical activities, inspections, or to observe health care operations in treatment facilities. Work also includes frequent lifting of moderately heavy items weighing less than 23 kilograms (i.e., under 50 pounds) such as record boxes, equipment, or raw materials. The work is primarily sedentary, although some physical effort may be required, walking, standing, carrying light items such as manuals or briefcases, or driving or traveling by motor vehicle. Work Conditions: The work involves regular and recurring exposure to moderate risks, discomfort, and unpleasantness such as: Contagious diseases; Infectious materials; Toxic or irritating chemicals; Carcinogenic materials; Noxious fumes; Explosive particles; Flammable liquids; Radiation; Pathogenic bacteria. Special safety precautions such as protective clothing, radiation lead shielding, and personal protective equipment are necessary. The work requires monthly (average 10-20%) travel, both locally and nationally.