The position will directly support the National Center for Collaborative Healthcare Innovation (NCCHI). NCCHI is managed in collaborative agreement with the national VHA Innovation Ecosystem; under the Deputy Undersecretary for Health, and the VA Palo Alto Health Care System (VAPAHCS); in the VA Sierra Pacific Network (VISN 21).

Duties

Incumbent plays a critical role in planning, developing, and influencing implementation of quality, regulatory and medical device design projects that support the success of NCCHI. Oversees all 3D manufacturing and XR equipment use and management. Identifies new equipment needs, selects appropriate equipment, drives contracting, and oversees installation. Oversees all equipment maintenance, including vendor maintenance contracts. Strategic planning for operations; monitors emerging technologies, anticipates future demands and how to meet them. Facility development, optimization of production workflow. Ensures facilities, equipment, and personnel comply with all safety requirements. Works with supply chain to ensure supplies are delivered to enable uninterrupted production. Maximizes manufacturing uptime, responsiveness, and develop backup options as necessary. Assists with the development of VHA enterprise-level criteria and procedures for medical device design development, testing, manufacturing, and deployment with regards to quality and regulatory issues, ensuring that Veterans receive treatments with the highest levels of safety and efficacy. Responsible for full compliance with national policies and directives regarding 3DP and XR, as well as overseeing successful tracking and reporting of Quality Management System requirements to the Food and Drug Administration (FDA). Collaborates with clinical staff members in the design and development of medical devices, 3DP, and XR systems, and must be capable of comprehending surgical approach, patient anatomy, and potential complications that might impact the safety and efficacy of the device. Likewise, must be able to communicate engineering and regulatory principles in a manner understandable by clinical staff. Serves as a product manufacturing technical expert, advisor and thought leader/influencer for the development of systems and components in accordance with new and changing technical requirements; understands and complies with medical device manufacturing guidelines and regulations per FDA, ISO and AAMI standards. He/she must be able to influence VHA staff to comply with and accept new and changing policies, given the rapidly changing regulatory landscape of hospital-based advanced manufacturing. This may require skill in dealing with skeptical or uncooperative people to obtain the desired results. Provides engineering expertise and advice to NCCHI strategic planning teams, both within VAPAHCS and to additional VA hospitals across the enterprise and is a key member of the planning team for short, medium, and long-term goals. Innovates, plans, directs, and coordinates the timely execution and attainment of project goals and milestones associated with NCCHI. Assignments often require using expertise in advanced manufacturing and engineering to solve unique problems by applying experimental theories, researching possible solutions from fields outside of engineering, and collaborating with stakeholders in different disciplines to accomplish assignments. He / She must use resourcefulness and initiative in independently planning the details for the accomplishment of assignments. Must be able to learn new technology and identify trends in advanced manufacturing and have the ability to communicate this information in the capacity of both an advisor and influencer to administrative, clinical, and technical staff both within and outside of VHA. He/she must be able to speak with representatives of the media or professional associations in moderately unstructured settings. Contributes to the advancement of VA technology both within the Federal sector and in the private sector through independent research and written and oral presentations, including preparation of technical, informational, analytical, and graphical documentation and scientific manuscripts. Presentations are to a broad audience, both within and external to VA, ranging from national conferences to inter-agency meetings to briefings to VHA leadership. The incumbent will train and mentor VA employees. Work Schedule: Monday - Friday; 8:00am - 4:30pm Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process. Virtual: This is not a virtual position. Position Description/PD#: Management & Program Analyst - Project Manager/PD01949O Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI): Not Approved Permanent Change of Station (PCS): Not Authorized PCS Appraised Value Offer (AVO): Not Authorized

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 10/31/2024. Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-13 position you must have served 52 weeks at the GS-12. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. You may qualify based on your experience as described below: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-12 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Conduct needs analyses through the use of advanced techniques (i.e., quantitative and/or qualitative), to assess success, safety, and opportunities for improvement, as well as define opportunities and prioritization of new or upgraded innovative solutions; Configure and implement applications development; Identify risks and expectations for addressing risks; Develop standards and a common development methodology covering such activities as prototyping, test plans, change-control procedures, security processes and guidelines, metadata capture and delivery and repository functionality, service-level agreements, help desk services, system review, training, and application, and release; Maintain, manage, and configure a variety of complementary systems for the centers and VHA's broader goals; Collect, manage, and respond to staff feedback about the systems under their responsibility, as well as leading redesign initiatives as required; Responsible for the technical maintenance and support as well as authorization to implement and utilize the systems in collaboration with other key stakeholders such as from the Office of Information Technology as well as Biomed, Engineering, Safety, Infection Control, and Office of Facility Planning and Development, as well as others as required; Responsible for the safety and security of the hardware and software assets. You will be rated on the following Competencies for this position: Administration and ManagementOral CommunicationProject ManagementQuality Management 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. Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Physical Requirements: The work is primarily sedentary and is accomplished in an office environment. Some walking and standing may occur in the course of a normal workday. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.

Education

There is no educational substitution at this grade level.

Contacts

• Address Palo Alto VA Medical Center 3801 Miranda Avenue Palo Alto, CA 94304 US
• Name: Victor Chan
• Phone: 832-343-2736
• Email: [email protected]