Clarification from the agency

NOTE: The 2-page Resume requirement does not apply to this occupational series. For more information, refer to Required Documents below. The area of consideration is limited to Current Permanent Puget Sound VA HCS Employees only.

NOTE: The 2-page Resume requirement does not apply to this occupational series. For more information, refer to Required Documents below.

• Plays a critical role in planning, developing, and influencing implementation of quality, regulatory and medical device design projects that support the success of X_Labs.
• Takes in new patient-specific medical device cases and segments medical images according to written work instructions.
• Trains under established protocols for each position and each device they work on.
• Works in collaboration with physicians, case planners, and designers, as well as manufacturing staff to design medical devices.
• Comprehends clinical approach, clinical datasets (DICOM), patient anatomy, and potential complications that might impact the safety and efficacy of the device.
• Continuously evaluates work for safety, efficacy, and efficiency improvements, and writes change orders to implement.
• Maintains an in-depth understanding of medical device regulations, internal quality management systems, and VA regulations.
• Operates within the VA's Quality Management System (QMS) and works to continuously improve the QMS.
• Participates in the transfer of new projects from development into production in collaboration with development engineers, quality engineers, manufacturing engineers, regulatory advisors, and more.
• Assists other sites in setting up manufacturing facilities including documentation, training, and site visits
• Assists with the development of VHA enterprise-level criteria and procedures for medical device design development, testing, manufacturing, and deployment with regards to quality and regulatory issues, 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 oversee any remediation required to ensure successful inspections.
• Collaborates with clinical staff members in the design and development of medical devices
• Serves as a product manufacturing 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.
• 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 have the ability to 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.
• 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.
• 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.

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

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 working outside and inside, constant noise, dust, working closely with others, and working alone.

How you will be evaluated

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

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

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
• Resume/CV
• Professional Certification
• Resume
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

Veterans' Preference: When applying for Federal Jobs, eligible Veterans should claim preference for 5pt (TP), 10pt (CP/CPS/XP), or for Sole Survivor Preference (SSP) in the questionnaire. You must provide a legible copy of your DD214(s) which shows dates and character of service (honorable, general, etc.). If you are currently serving on active duty and expect to be released or discharged within 120 days you must submit documentation related to your active duty service which reflects the dates of service, character of service (honorable, general, etc.), and dates of impending separation. Additionally, disabled veterans and others eligible for 10-point preference (such as widows or mothers of eligible Veterans) must also submit an SF-15 "Application for 10 Point Veteran Preference" with required proof as stated on the form. Documentation is required to award preference. For more information on Veterans' Preference, please visit Feds Hire Vets - Veterans - Job Seekers - Veterans' Preference.

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

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