Summary The Biomedical Engineer is part of the Biomedical Engineering Section of the Engineering Service at San Francisco Veterans Affairs Health Care System (SFVAHCS) in San Francisco, CA. This position provides VACCHCS with professional biomedical engineering support. The biomedical engineer assists with developing long-term strategies that affect the implementation of complex medical technology in the Medical Center. Responsibilities This position shares the responsibility for managing network security issues for medical systems, and the information communicated across these systems. The biomedical engineer supports the institution by assisting with capital asset and infrastructure planning. The biomedical engineer provides leadership that ensures high quality and responsive customer service within the Biomedical Engineering Section. Duties include but are not limited to the following: Applies clinical engineering principles to conduct a Medical Equipment Management Program that meets or exceeds requirements from the Joint Commission, FDA, NFPA, VA OIG, and other applicable healthcare regulatory requirements. Provides project management, or oversees project management for purchase, planning, construction design review, installation, managing network security and in-service training stages of major medical instrumentation projects. Serves as a technical advisor on the Medical Center's Equipment Committee and VISN 21 High Tech, High Cost Equipment Council. Conducts capital asset and infrastructure planning for medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment. Acts as a subject matter expert in the field of Biomedical Engineering, supporting specialized clinical technology, including system administration, training, quality assurance, and life-cycle management. Serves as a part of a team responsible for the overall program of medical equipment maintenance, including planning, selection, consultation, installation and maintenance of medical equipment. Represents the Medical Center in meetings with manufacturers, vendors and their engineers in matters involving medical instrumentation. Manages recalls and safety alert program for medical devices, including medical device hazard investigations, to assure compliance with patient safety goals, SMDA, and Joint Commission requirement. Advises clinical and administrative staff on medical technology, including existing and emerging technology, which addresses viability, long-term suitability, and/or safety. Utilizes knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology within VHA. Develops curriculum for a continuing education program that addresses the safe and effective use of medical technology .. Develops a cross-training program for Biomedical Engineering Staff. Receives assignments and major objectives from the Chief Biomedical Engineer. Advises on the feasibility, programs, attainment of major objectives, systems and equipment safety precautionary requirements, and cost specifics dictated by sound engineering principles. Utilizes knowledge of multiple scientific disciplines, Federal Codes, and Department of Veterans Affairs regulations. Work Schedule: Monday - Friday, 8:00 am to 4:30 pm Compressed/Flexible: Not Available Telework: Not Available Virtual: This is not a virtual position. Functional Statement # 000000 Relocation/Recruitment Incentives: Not Authorized Student Loan Repayment Program (SLRP): This occupational series is eligible for the Student Loan Repayment Program (SLRP). Repayment is limited to $10,000 annually, up to $60,000 in lifetime awards. Participants must sign a service agreement and maintain an acceptable level of performance to remain eligible for this program. Requirements Conditions of Employment You must be a U.S. Citizen to apply for this job. All applicants tentatively selected for VA employment in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied employment with VA. Selective Service Registration is required for males born after 12/31/1959. Must be proficient in written and spoken English. You may be required to serve a probationary period. Subject to background/security investigation. Selected applicants will be required to complete an online onboarding process. Must pass pre-employment physical examination. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details. Qualifications Applicants pending the completion of educational or certification/licensure requirements may be referred and tentatively selected but may not be hired until all requirements are met. BASIC REQUIREMENTS Citizenship. United States citizen. Education and/or Experience. The individual must meet either item (1) or (2) below to meet this requirement: 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 in item 1. Grandfathering Provision. All persons employed in VHA in this occupation, on the effective date of this qualification standard, are considered to have met all qualification requirements for the title, series and grade held, including positive education, and/or certification/registration that are part of the basic requirements of the occupation. For employees who do not meet all the basic requirements in this standard, but who met the qualifications applicable to the position at the time they were appointed to it, the following provisions apply: 1. Such employees in an occupation that does not require a certification/registration, may be reassigned, promoted, or demoted within the occupation. 2. Employees who are appointed on a temporary basis, prior to the effective date of the qualification standard, may not have their temporary appointment extended, or be reappointed on a temporary, or permanent basis, until they fully meet the basic requirements of the standard. 3. Employees initially grandfathered into this occupation, who subsequently obtain additional education and/or certification/registration, must maintain the required credentials as a condition of employment in the occupation. 4. If an employee, who was retained in an occupation, leaves that occupation, the employee loses protected status. Physical Requirements. Must undergo and pass a pre-employment physical. English Language Proficiency. Must be proficient in spoken and written English in accordance with VA Policy. GRADE REQUIREMENTS Grade Determinations. In addition to the basic requirements for employment listed above the following criteria must be met. Biomedical Engineer, GS-07 Experience. None beyond the basic requirements. Education. Bachelor's degree as outlined in section1 of the basic requirements, or CCE certification with at least a bachelor's degree not listed in section 1 of the basic requirements. Demonstrated Knowledge, Skills, and Abilities. None beyond the basic requirements. Biomedical Engineer, GS-09 Experience. At least one year of specialized experience equivalent to the next lower level. OR, Education. Master's degree in Biomedical Engineering, or a related field of study, as outlined under the basic requirements, education, section 1. OR, Bachelor's degree, as outlined under the basic requirements, education, section 1. 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 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. Biomedical Engineer, GS-11 Experience. At least one year of specialized experience equivalent to the next lower level and must fully meet the KSA's at the level. OR, Education. Ph.D., or equivalent doctoral degree in Biomedical Engineering, or a related field of engineering, as outlined under the basic requirements, education, section 1, listed above. OR, Bachelor's degree, plus three full years of progressively higher level graduate education in a related field of study, as outlined under the basic requirements, education, section 1, listed above. Demonstrated Knowledge, Skills, and Abilities. In addition to the experience above, the candidate 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. Biomedical Engineer, GS-12 Experience. Completion of at least one year of specialized experience equivalent to the next lower 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 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. Reference: VA Handbook 5005/104 PART II APPENDIX G38, 3/25/2019 Applicants may be selected from GS-7 to GS-12. Physical Requirements: Light lifting and carrying, under 15 pounds. Ability to distinguish basic colors and shades of colors. 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. Additional Information This job opportunity announcement may be used to fill additional vacancies. This position is in the Excepted Service and does not confer competitive status. Pursuant to VHA Directive 1193.01, VHA health care personnel (HCP) are required to be fully vaccinated against COVID-19 subject to such accommodations as required by law (i.e., medical, religious or pregnancy). VHA HCPs do not include remote workers who only infrequently enter VHA locations. If selected, you will be required to be fully vaccinated against COVID-19 and submit documentation of proof of vaccination before your start date. The agency will provide additional information regarding what information or documentation will be needed and how you can request a legally required accommodation from this requirement using the reasonable accommodation process. To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a VA job announcement includes language requiring applicants to be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply to this Job Announcement. VA may request information regarding your vaccination status, if selected, for the purposes of implementing other workplace safety protocols, such as masking, physical distancing, testing, travel, and quarantine. If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.