Supervisory Biomedical Engineer (Clinical)

Clarification from the agency

NOTE: The 2-page Resume requirement does not apply to this position. For more information, refer to Required Documents below. This announcement is open to current permanent Department of Veterans Affairs employees. Applicants will be referred in the following order: 1. Current permanent Facility employees. 2. Current permanent Agency (Department of Veterans Affairs) employees.

This position is aligned under the Office of the Deputy Director, receiving supervision from the Chief of X_Labs (Formerly known as VA Ventures). The incumbent will achieve assigned professional objectives that supplement the core objectives to fulfill requirements for the Biomedical Engineering Career Field.

FUNCTION OR SCOPE OF ASSIGNED DUTIES:

• Participate in medical device product development projects as the portfolio management representative, guide the team on alignment with strategic goals of the project. Advise development team on how customer requirements influence the product development process and ensure that design verification activities confirm the design output meets the design input for the project and that design validation activities are appropriate to show through objective evidence that the devices developed meet user needs.
• Create and implement processes for portfolio tracking, including oversight of selection and monitoring and evaluation of pilot technologies and special initiative projects.
• Review systems to ensure proper documentation, fidelity, and post-pilot assessments are conducted, guaranteeing initiatives are managed in alignment with portfolio management best practices and VA priorities.
• Develop VHA enterprise-level criteria and procedures for medical device design development, testing, manufacturing, and deployment, ensuring Veterans receive treatments with the highest levels of safety and efficacy.
• Collaborate with clinical staff members in the design and development of medical devices, 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.
• Ensure all documentation, including electronic records, comply with standards for quality management and data security in alignment with medical device regulations.
• Integrate lessons learned and stakeholder feedback into future initiatives and maintain repository control over all pilot project documentation and outcomes.
• Act as a subject matter expert and strategic influencer for the identification, pilot, and potential roll-out of emerging medical technologies and special initiatives. Demonstrate deep clinical insight, enabling translation of clinical workflows and needs into actionable design requirements and project inputs.
• Actively engage and communicate with multidisciplinary clinicians and hospital staff, employing shadowing and direct observation when needed to inform product development.
• Provide authoritative guidance on regulatory, compliance, and technology adoption challenges, effectively driving organizational buy-in and adoption of new enterprise-wide initiatives, while addressing resistance and fostering stakeholder consensus.
• Provide engineering expertise and advice to VA 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.
• 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.
• 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. Must be able to speak with representatives of the media or professional associations in moderately unstructured settings.
• Have knowledge of the FDA's quality system regulation, electronic records, registration and listing requirements, as well as different pathways to provide devices to patients (510(k), expanded access, and IDE exemptions).
• Contribute to the advancement of VA 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. 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.
• Supervise a team of Clinical and development engineers tasked with customer engagement and customer discovery activities.

Work Schedule: Monday - Friday, negotiable (0600-1800).
Telework: Ad-hoc.
Virtual: This is a virtual position.
Functional Statement #: 000000.
Relocation/Recruitment Incentives: Not authorized.
Permanent Change of Station (PCS): Not authorized.

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 identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment.
• Must pass pre-employment physical evaluation.
• 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.

BASIC REQUIREMENTS.
Citizenship. Be a citizen of the United States. (Non-citizens may be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy).

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 above.

English Language Proficiency. Biomedical Engineers must be proficient in spoken and written English to be appointed as authorized by 38 U.S.C. § 7403(f).

GRADE REQUIREMENTS.
Grade Determinations. In addition to the basic requirements for employment listed above, the following education and experience criteria must be met when determining the grade of candidates:

Supervisory Biomedical Engineer (Clinical), GS-13.
(a) Experience. Completion of at least one year of experience equivalent to the next lower level, and must fully meet the KSAs at that level.

(b) 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.

Assignment. For all assignments above the full performance level, the higher-level duties must consist of significant scope, complexity (difficulty), range of variety, and be performed by the incumbent at least 25% of the time. At this level, employees are supervisors and are at the facility level. The supervisory biomedical engineer (clinical) is responsible for the professional and administrative management of a facility biomedical engineering program. Such individuals have responsibility supervising technical staff, including lower level engineers, biomedical engineering technicians, and other staff. The range of supervisory responsibility includes development of performance standards and performance evaluations; recommendations for appointments, awards, advancements, and when appropriate, disciplinary actions; and identification of continuing training needs etc. The supervisory biomedical engineer (clinical) is responsible for financial management of budget resources allocated to support quality assurance and maintenance activities necessary to assure the facility's medical equipment is available for patient care activities. The supervisory biomedical engineer (clinical) is responsible for compliance and reporting of medical device cyber security and isolation for facilities under their management oversight.

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: There are no physical requirements for this occupation per OCHCO Communications email to VA Handbook 5019, updated on 4/17/2026.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

What are KSAs?
In the federal hiring process, Knowledge, Skills, and Abilities (KSAs) are a list of special qualifications and personal attributes that you need to have for a particular job/grade level (see Qualifications section of this announcement).

• Knowledge statements refer to an organized body of information usually of a factual or procedural nature which, if applied, makes adequate performance on the job possible. A body of information applied directly to the performance of a function. Skill statements refer to the proficient manual, verbal or mental manipulation of data or things.
• Skills can be readily measured by a performance test where quantity and quality of performance are tested, usually within an established time limit.
• Ability statements refer to the power to perform an observable activity at the present time. This means that abilities have been evidenced through activities or behaviors that are similar to those required on the job. Note that abilities are different from aptitudes. Aptitude is only the potential for performing the activity.

Although not required at the time of application, we highly recommend submitting a supplemental document with your written responses to the KSAs required at each grade level you wish to be considered. If you choose not to submit KSA responses, please ensure your resume includes details of your experience that fully demonstrate the required KSAs as described in the "Qualifications" section of this announcement.

5 Tips for Writing a Federal Resume - FederalPay.org (https://www.federalpay.org/articles/5-tips-for-writing-a-federal-resume)

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Your application, resume, C.V., and/or supporting documentation will be verified. Please follow all instructions carefully. Errors or omissions may affect consideration for employment.

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.

The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.

It is the policy of the VA to not deny employment to those that have faced financial hardships or periods of unemployment.

Veterans and Transitioning Service Members: Please visit the VA for Vets site for career-search tools for Veterans seeking employment at VA, career development services for our existing Veterans, and coaching and reintegration support for military service members.

To apply for this position, you must provide a complete Application Package which includes:

• Resume
• SF-50/ Notification of Personnel Action
• Transcript

RESUME REMINDER: Your resume must include the following information for each job listed:

• Job title
• Month & Year start/end dates (e.g. June 2016 to April 2018)
• Full-time or part-time status (include hours worked per week)
• Duties (be as detailed as possible)
• Series and Grade, if applicable, for all Federal positions you have held

Please be aware that your answers will be verified against information provided on your resume. Be sure that your resume clearly supports your responses to all questions by addressing your work experience in detail.

Special Note for Applications: To complete your application, please use the following link https://vacareers.va.gov/wp-content/uploads/sites/5/Resume.docx to download the standard Clinical Resume Document. This one-page document does not need to be modified and must be uploaded into the two-page restricted 'Resume' document upload field.

Your full resume/CV may be uploaded without page limitation into the 'Other' document upload field.

The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50's (current/former Federal employees), etc.

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (VA)
• License
• CV or Resume over 2 pages long
• Certification as a Certified Clinical Engineer (CCE)
• Other (3)
• Performance Appraisal
• Professional Certification
• Resume
• SF-50/ Notification of Personnel Action
• Transcript

Veterans' Preference: Veterans' preference does not apply for internal or other current permanent Federal agency employees.

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