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.

May qualify based on being covered by the Grandfathering Provision as described in the VA Qualification Standard for this occupation (only applicable to current VHA employees who are in this occupation and meet the criteria).

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/.

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.

• Benefits

A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Review our benefits

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

• Required Documents

As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you’re a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you’re eligible under their policies.

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

• Resume
• Transcript

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
• Other (1)
• Professional Certification
• Resume
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

IF YOU ARE RELYING ON YOUR EDUCATION TO MEET QUALIFICATION REQUIREMENTS:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

• How to Apply

All applicants are encouraged to apply online. To apply for this position, you must complete the full questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (ET) on 07/25/2025 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/12764656.

• To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USA JOBS resume and/or other supporting documents and complete the occupational questionnaire.
• Click Submit My Answers to submit your application package.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.

IF YOU ARE RELYING ON YOUR EDUCATION TO MEET QUALIFICATION REQUIREMENTS:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
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DUTIES

Duties listed below are for GS-12 (full performance level), developmental grades will differ in complexity and oversight.

• Plans, develops, and implements new medical device projects across the VHA enterprise, ensuring that Veterans receive treatments with the highest levels of safety and efficacy.
• Responsible for full compliance with national policies and directives regarding Advanced Manufacturing procedures, as well as overseeing successful tracking and reporting of Quality Management System requirements to the Food and Drug Administration (FDA). Ensures that VHA facilities registered with FDA are prepared for inspections, and oversees any remediation required to ensure successful inspections.
• Collaborates with clinical staff members in the design and development of medical devices, and comprehends surgical approach, patient anatomy, and potential complications that might impact the safety and efficacy of the device. Communicates engineering and regulatory principles in a manner understandable by clinical staff.
• Serves as a product technical expert, advisor and thought leader/influencer for the development of medical devices in accordance with new and changing technical requirements; understands and complies with medical device development guidelines and regulations per FDA, ISO and AAMI standards. 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.
• Develops products within the VA’s Quality Management System and works to continuously improve the QMS. This includes documenting the development and manufacturing processes.
• Collaborate with quality engineers, manufacturing engineers, regulatory advisors, technicians, clinicians, and more to develop medical devices.
• Participate in the transfer of new projects into Manufacturing.
• Assignments often require using expertise in medical devices, healthcare, quality, regulations, 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 use resourcefulness and initiative in independently planning the details for the accomplishment of assignments.
• Applies new technologies, identifies trends in healthcare, and communicates this information in the capacity of both an advisor and influencer to administrative, clinical, and technical staff both within and outside of VHA. Speak with representatives of the media or professional associations in moderately unstructured settings.
• 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. 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.
• Trains and mentors X_Labs employees.

Total Rewards of a Allied Health Professional
Work Schedule: Monday - Friday, hours negotiable (7AM - 5PM)
Recruitment Incentive (Sign-on Bonus): Not Authorized
Permanent Change of Station (Relocation Assistance): Not Authorized
EDRP Authorized: Former EDRP participants ineligible to apply for incentive. Contact VHAEDRPProgramSupport@va.gov, the EDRP Coordinator for questions/assistance. Learn more
Pay: Competitive salary and regular salary increases When setting pay, a higher step rate of the appropriate grade may be determined after consideration of higher or unique qualifications or special needs of the VA (Above Minimum Rate of the Grade).
Paid Time Off: 37-50 days of annual paid time offer per year (13-26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year)
Selected applicants may qualify for credit toward annual leave accrual, based on prior [work experience] or military service experience.
Parental Leave: After 12 months of employment, up to 12 weeks of paid parental leave in connection with the birth, adoption, or foster care placement of a child.
Child Care Subsidy: After 60 days of employment, full time employees with a total family income below $144,000 may be eligible for a childcare subsidy up to 25% of total eligible childcare costs for eligible children up to the monthly maximum of $416.66.
Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA
Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement)
Telework: Ad-hoc
Virtual: This is not a virtual position.
Functional Statement #: 00000
Permanent Change of Station (PCS): Not Authorized

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
• Other (1)
• Professional Certification
• Resume
• SF-15
• SF-50/ Notification of Personnel Action
• Transcrip

All applicants are encouraged to apply online. To apply for this position, you must complete the full questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (ET) on 07/25/2025 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/12764656.

• To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USA JOBS resume and/or other supporting documents and complete the occupational questionnaire.
• Click Submit My Answers to submit your application package

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
• Other (1)
• Professional Certification
• Resume
• SF-15
• SF-50/ Notification of Personnel Action
• Transcrip