The position is assigned to the Assistive Technology Program under the Physical Medicine and Rehabilitation Service at the Richmond VA Medical Center. The Advanced Manufacturing Program aligns with the current initiatives of the VHA Office of Healthcare Innovation and Learning (OHIL). VHA OHIL's mission is to enable the discovery and spread of health care innovations within VHA that exceed expectations, restore hope, and builds trust within the Veteran community.

Duties

Duties include but are not limited to: a. Provides management and oversight of one or more clinical area that is served with Advanced Manufacturing. b. Coordinates with clinical staff members and must be capable of comprehending the task that is being asked of them. c. Performs various technical engineering, scanning, modeling, and analyzing tasks in support of Advanced Manufacturing design, development, and production utilizing 3D printing technologies and other manufacturing techniques. d. Applies judgment in adapting practices and techniques to specific situations usually through a series of related processes. Initiates resourcefulness and independent planning the details for the accomplishment of assignments. e. Performs assignments typically dealing with design, process and productive development required in medical device manufacturing. f. Designs shape, size structures and mechanical aspects of assigned items and identifies support structure options in terms of feasibility for advanced manufacturing. Identifies printing materials and machine parameters to be used, as well as cost, and post-processing of advanced manufacturing item. Computes loads, stresses, strength and other features; coordinates with engineers, scientists and researchers for more theoretical, analytical or specialized approaches to problems and for inter-relationships and integration of technical efforts. Performs fit analysis of complex assemblies using the Computer Aided Design (CAD) system. g. Within overall assignments, incumbent maintains a thorough knowledge of 3D scanning operational and software capabilities of item to be 3D printed. Prepares complete final CAD design and coordinates with engineers and technical staff through use of CAD systems. Visits work areas to maintain a comprehensive understanding of overall item progress and quality, develops and monitors process and planning instructions and recommends possible solutions to minimize production and post-processing schedule. Provides recommendations for acceptance or rejection of 3D printed item on a case by case basis within the individual program intent and customer needs. Participates in initial planning discussions for projects, attends subsequent staff meetings and participates in discussions relating to assignments. h. Serves as a product manufacturing technical expert and advisor for the development of?additive manufactured components in accordance with new and changing technical requirements as well as understanding and complying to medical device manufacturing guidelines and regulations per FDA, ISO and AAMI standards. i. Capable of learning new technology, identify trends, and have the ability to communicate this information in an advisory capacity to administrative, clinical, and technical staff as well as implement the information learned. j. Prepares oral and written communication in forms of documentation and presentations. Documentation will include the preparation of technical, informational, analytical, and graphical documentation. k. Knowledge of the medical equipment management plan, must have the ability to participate in medical device hazard investigations, and assure compliance with patient safety goals as needed. l. Independent research and additive manufacturing project management. m. Knowledge of organizational concepts and an understanding of operational needs. n. Duties or projects typically include facility-based work and may include VISN or VHA OHIL projects in alignment with Advanced Manufacturing. o. Create, implement and verify/validate processes within an OAM Lab for imaging acquisition, segmentation, OAM model refinement, advanced manufacturing technology (i.e. 3D printing) and post processing. p. Establishes processes for development, production, and sustainment. Phases include: process development; medical scan reconstruction; design influence for manufacturing; additive manufacturing; rapid prototyping; manufacturing technology; design of tools, fixtures, surgical guides and custom implants. Develops procedures and methods for construction of medical models, devices, and research and development (R&D) initiatives. Identifies proper materials based on requirements, dimensional tolerances, and secondary processing such as finishing. q. Establishes and implements quality system management including quality assurance processes, process documentation/standard operating procedures; process control; quality control, quality acceptance test planning and conduct; destructive and non-destructive testing; and inspection. Designs, sets up and conducts testing of items or systems during the R&D, production, and sustainment phases. Work Schedule: Monday-Friday 8-4:30 Telework: Not Authorized Virtual: This is not a virtual position Functional Statement #: 000000 Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Financial Disclosure Report: Not required

Requirements

Qualifications

Basic Requirements: United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy. English Language Proficiency: Candidates will not be appointed under authority of 38 U.S.C. chapters 73 or 74, to serve in a direct patient-care capacity in VHA who is not proficient in written and spoken English. Biomedical Engineer Education: Bachelor's Degree or Higher in Engineering. To be creditable, the curriculum must be from a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET), as a professional engineering curriculum. Examples of acceptable engineering degrees include: Biomedical Engineering, Clinical Engineering, Bioengineering, Biomechanical Engineering, Electrical Engineering, Mechanical Engineering, and Biochemical Engineering. Titles may vary from educational institutions and change over time.or Certification as a Certified Clinical Engineer (CCE) and a bachelor's degree not listed above. Experience must have been attained in a healthcare setting for Biomedical Engineer (Clinical) positions Grade Determinations: GS-7 (Entry Level) Experience. None beyond the basic requirements. Education: Bachelor's Degree or Higher in Engineering. To be creditable, the curriculum must be from a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET), as a professional engineering curriculum. Examples of acceptable engineering degrees include: Biomedical Engineering, Clinical Engineering, Bioengineering, Biomechanical Engineering, Electrical Engineering, Mechanical Engineering, and Biochemical Engineering. Titles may vary from educational institutions and change over time.OR,(2) Certification as a Certified Clinical Engineer (CCE) and a bachelor's degree not listed above. Demonstrated Knowledge, Skills, and Abilities None beyond the basic requirements GS-9 (Developmental Level 1) Experience. At least one year of specialized experience equivalent to the GS-7 entry level (Basic Requirements) OR, Education Master's degree in Biomedical Engineering, or a related field of study. OR, Bachelor's degree in Biomedical Engineering, or a related field of study OR Certification as a Certified Clinical Engineer (CCE) and a bachelor's degree not listed as a related field, plus two full years of progressively higher level graduate education in a related field of study, provided the applicant's total background demonstrates the KSAs for the GS-9 level assignment. Demonstrated Knowledge, Skills, and Abilities In addition to the experience above, the candidate's resume must demonstrate all of the following KSAs: Knowledge of the principles, theories, concepts, and practices of the Biomedical Engineering profession. Ability to interpret relevant codes, regulations, guidelines, and standards, and make recommendations to ensure compliance with medical center programs. Ability to understand the operational needs of clinical services in the health care system. Ability to prepare material on current technical topics and trends, for presentation to other technical staff and mid-level hospital management, and the ability to keep abreast of changes in technology. GS-11 (Developmental Level 2) Experience. At least one year of specialized experience equivalent to the grade of GS-9 (Developmental level 1) OR, Education Ph.D., or equivalent doctoral degree in Biomedical Engineering, or a related field of engineering. OR, Bachelor's degree, plus three full years of progressively higher level graduate education in a related field of study, OR Certification as a Certified Clinical Engineer (CCE) and a bachelor's degree not listed as a related field. Demonstrated Knowledge, Skills, and Abilities. In addition to the experience above, the candidate's resume must demonstrate all of the following KSAs: Ability to implement and/or sustain an equipment management or biomedical research program that meets The Joint Commission (TJC), National Fire Protection Association (NFPA), or other applicable regulatory requirements. Ability to develop material for a continuing education program for clinical or research staff, that address the principles and application of medical technology, and/or biomedical theory used in healthcare. Ability to advise staff on emerging medical technology[, or research procedures], while keeping abreast of changes in such technology, and utilizing the information to solve biomedical engineering problems. Knowledge of basic project management principles, as applied to the healthcare setting and medical equipment, and information system implementation. GS-12 (Full Performance Level)Experience: Completion of at least one year of specialized experience equivalent to the GS-11 grade level; or completion of a post-doctoral research fellowship in the field of biomedical engineering, and must fully meet the KSAs at that level. Demonstrated Knowledge, Skills, and Abilities: In addition to the experience above, the candidate's resume must demonstrate all of the following KSAs: Ability to conduct a medical equipment management [or biomedical research program that is compliant with applicable healthcare standards and regulatory agencies. Ability to develop a curriculum for a continuing education program, that address the safe and effective use of medical technology, and/or research devices. Ability to manage a recall and safety alert program for medical devices, including medical device hazard investigations, to assure compliance with patient safety goals, SMDA, and [TJC] requirements. Ability to conduct capital asset and infrastructure planning for medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment. Ability to function as the subject matter expert in the field of biomedical engineering, directly supporting specialized clinical technology, including service, system administration, training, quality assurance, and life-cycle management. Ability to effectively advise clinical and administrative staff on medical technology, including existing and emerging technology, which addresses viability, long-term suitability, compatibility, and/or safety. Knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology within VHA. Skill in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of the organization. Ability to apply project management principles to deployment of medical equipment and health information technologies. Assignment. At the full performance level, employees work under general supervision, with wide latitude to exercise independent judgment. Drawing upon extended professional and technical experience, employees demonstrate anintimate understanding of complex clinical and biomedical subject matter. They serve as institutional resources, working extensively with clinical stakeholders, supporting clinical services by leading market References: VA Handbook 5005/104 PART II APPENDIX G38 March 25, 2019 The full performance level of this vacancy is GS-12. The actual grade at which an applicant may be selected for this vacancy is in the range of GS-7 to GS-12

Education

IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address Central Virginia VA Health Care System 1201 Broad Rock Boulevard Richmond, VA 23249 US
• Name: Ryan Leash
• Phone: 980-401-2554
• Email: [email protected]