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  • Supervisory Biomedical Engineer (Clinical)

    Veterans Affairs, Veterans Health Administration (Seattle, WA)



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    Summary This position is aligned under the Office of the Deputy Director, receiving supervision from the Director of Product Development of X_Labs. The Incumbent plays a critical role in planning, developing, influencing, and implementing medical device development projects that support the success of X_Labs. Responsibilities NOTE: The 2-page Resume requirement does not apply to this occupational series. For more information, refer to Required Documents below. Duties include, but are not limited to: Identifies new staffing, facility, and equipment needs, and facilitates fulfilling those needs. Strategic planning for development; monitors emerging technologies, anticipates future demands and how to meet them. Staff development, optimization of development workflow. Assists other sites in setting up manufacturing facilities including documentation, training, and site visits. Develops VHA enterprise-level criteria and procedures for medical device development, testing, manufacturing, and deployment, ensuring that Veterans receive treatments with the highest levels of safety and efficacy. Responsible for full compliance with VHA national policies and directives, VHA Quality Management System, and FDA regulations regarding product development procedures. Collaborates with clinical staff members in the design and development of medical devices, and must be capable of comprehending clinical 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 technical expert, advisor and thought leader/influencer for the development of additively manufactured 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. Provides engineering expertise and advice to X_Labs strategic planning teams, both within VAPSHCS 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 the X_Labs program. Uses 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. Must be able to learn new technology and identify trends in advanced manufacturing and can communicate this information in the capacity of both an advisor and influencer to administrative, clinical, and technical staff both within and outside of VHA. Contributes to the advancement of X_Labs 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. Supervises a team of engineers. Trains and mentors X_Labs employees. Assists with the determination of organizational changes in key positions within the program; ensures internal personnel-related programs are dealt with in a timely and efficient manner; communicates agency and local policies and priorities to all employees within the program; follows progress of each and recommends improvement to be made where warranted; and ensures labor/management relations are maintained in accordance with Medical Center policy and procedures and that other requirements such as effective use of performance standards, EEO policies, and other personnel-related rules and regulations are effectively enforced. Develops performance standards and evaluates the work of subordinates, ensuring reasonable equity among units, groups, teams or projects of performance standards and rating techniques developed by subordinate supervisors. Responsible for supervising technical staff, including lower-level engineers , biomedical engineering technicians, and other staff. Supervisory responsibilities include, but are not limited to development of performance standards and performance evaluations; recommendations for appointment, awards, advancements, and when appropriate, disciplinary actions; and identification of continuing training needs etc. Work Schedule: Monday - Friday, Day tour, between 7AM - 5PM, hours negotiable. Telework: Ad-hoc Virtual: This is not a virtual position. Functional Statement #: 00000 Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized 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. Subject to background/security investigation. Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued dentification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment. Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in the "Required Documents" section of this announcement. As a condition of employment for accepting this position, you will be required to serve a 1 or 2-year trial period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your trial period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest. Qualifications To qualify for this position, applicants must meet all requirements within 30 days of the closing date of this announcement. 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: 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. Biomedical Engineers must be proficient in spoken and written English in accordance with chapter 2, section D, paragraph 5a, this part. Education and/or Experience. The individual must meet either item (1) or (2) below to meet this requirement: (1) 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 in item (1) above. Grade Determinations: Supervisory Biomedical Engineer (Clinical), GS-13 Experience. Completion of at least one year of experience equivalent to the next lower level, 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: i. Knowledge of the management of overall department resources, i.e., finances, space, equipment, supplies, and staffing at the local level. ii. Ability to draft and/or recommend local policies and/or directives related to healthcare technology management. iii. Ability to balance multiple responsibilities, set priorities, delegate tasks, meet multiple deadlines, analyze organizational problems, and develop and implement effective solutions. iv. Ability to analyze organizational and operational problems to develop and implement solutions that result in efficient operations, and use data effectively to manage workload, quality, performance, and productivity within the area of responsibility. v. Skill in interpersonal relationships in leading and dealing with employees, team leaders, and managers, both within and outside the biomedical engineering program, to include conflict management, dispute resolution, mediation, or reasonable accommodations. Preferred Experience: Experience working under a quality management system. Reference: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/. The full performance level of this vacancy is GS-13. Physical Requirements: Moderate lifting and carrying (15-44 lbs.), use of fingers, both hands, walking, standing, repeated bending, ability for rapid mental and muscular coordination simultaneously, near vision correctable at 13" to 16" to Jaeger 1 to 4, ability to distinguish basic colors, ability to distinguish shades of colors, hearing (aid permitted), and mental and emotional stability. Environmental factors include constant noise, dust working closely with others, and working alone. 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/. Additional Information Receiving Service Credit or Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed. During the application process you may have an option to opt-in to make your resume available to hiring managers in the agency who have similar positions. Opting in does not impact your application for this announcement, nor does it guarantee further consideration for additional positions. This job opportunity announcement may be used to fill additional vacancies. This position is in the Excepted Service and does not confer competitive status. VA encourages persons with disabilities to apply. The health-related positions in VA are covered by Title 38, and are not covered by the Schedule A excepted appointment authority. If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement. Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative job offer. For more information about the Act and the complaint process, visit Human Resources and Administration/Operations, Security, and Preparedness (HRA/OSP) at The Fair Chance Act.

     


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