Biomedical Engineer (Process Engineer)

This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP application within four months of appointment. Program Approval, award amount (up to $200,000) & eligibility period (one to five years) are determined by the VHA Education Loan Repayment Services program office after review of the EDRP application. Former EDRP participants ineligible to apply.

Qualifications:

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).

Grade Determinations:
Biomedical Engineer, GS-7 (Entry Level)

• Experience. None beyond the basic requirements.
• Education. Bachelor's degree as outlined in paragraph (1) above, or CCE certification with at least a bachelor's degree not listed in paragraph (1) above.
• Demonstrated Knowledge, Skills, and Abilities (KSAs). None beyond the basic requirements.

Biomedical Engineer, GS-9 (Developmental Level 1)

• Experience. At least [one] year of specialized experience equivalent to the next lower level. OR,
• Education
  • i. Master's degree in Biomedical Engineering, or a related field of study, as outlined in paragraph (1) above.
  • OR,
  • ii. Bachelor's degree, as outlined in paragraph (1), plus two full years of progressively higher level graduate education in a related field of study, that 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:

1. Knowledge of the principles, theories, concepts, and practices of the Biomedical Engineering profession.
2. Ability to interpret relevant codes, regulations, guidelines, and standards, and make recommendations to ensure compliance with medical center programs.
3. Ability to understand the operational needs of clinical services in the health care system.
4. 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 (Developmental Level 2)

• Experience. At least [one] year of experience equivalent to the next lower level, [and must fully meet the KSAs at that level. OR,
• Education
  • i. Ph.D., or equivalent doctoral degree in Biomedical Engineering, or a related field of engineering, as outlined in paragraph (1).
  • OR,
  • ii. Bachelor's degree, plus three full years of progressively higher level graduate education in a related field of study, as outlined in paragraph (1).
• Demonstrated Knowledge, Skills, and Abilities. In addition to the experience above, the candidate must demonstrate all of the following KSAs:

1. 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
2. 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.
3. 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.
4. Knowledge of basic project management principles, as applied to the healthcare setting and medical equipment, and information system implementation.

Biomedical Engineer, GS-12 (Full Performance Level)

• 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:

1. Ability to conduct a medical equipment management or biomedical research program that is compliant with applicable healthcare standards and regulatory agencies.
2. Ability to develop a curriculum for a continuing education program, that address the safe and effective use of medical technology, and/or research devices.
3. 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.
4. Ability to conduct capital asset and infrastructure planning for medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment.
5. 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.
6. 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.
7. Knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology within VHA.
8. Skill in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of the organization.
9. Ability to apply project management principles to deployment of medical equipment and health information technologies

Preferred experience: Experience working directly with or in conjunction with living biological specimens or cultures. Experience learning new technologies and identifying trends in advanced manufacturing as well as the ability to communicate this information in the capacity of both an advisor and influencer to administrative, clinical, and technical staff.
And/Or,
Experience taking in new patient-specific medical device cases and segments medical images according to written work instructions. Working in collaboration with physicians, case planners, and designers, as well as manufacturing staff to design medical devices.

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-12. The actual grade at which an applicant may be selected for this vacancy is in the range of GS-7 to GS-12.

Physical Requirements: Moderate lifting (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 may be permitted), and mental and emotional stability. Environmental factors include, outside and inside, constant noise, dust, working closely with others, and working alone.

Responsibilities:

Functions of position listed below are for GS-12 full performance level, developmental grades will differ in complexity and scope.

Duties include, but are not limited to:

• The primary purpose of this position is to research, procure, maintain, develop, and sustain medical equipment which involves increasingly sophisticated digital equipment with significant IT interfacing due to connections to medical center information technology networks and other systems.
• Incumbent 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.
• Develops 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 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.
• Take in new patient-specific medical device cases and segments medical images according to written work instructions.
• Working directly with or in conjunction with living biological specimens or cultures.
• 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. This may require skill in dealing with skeptical or uncooperative people to obtain the desired results.
• 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 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 planning the details for the accomplishment of 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. He/she must be able to 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.
• The incumbent will train and mentor X_Labs employees.

Work Schedule: Monday - Friday, day tour, hours negotiable between 6AM - 6PM
Compressed: Available (at supervisor discretion)
Telework: Available, Ad-hoc only.
Virtual: This is not a virtual position.
Functional Statement #: 00000
Relocation/Recruitment Incentives: Not Authorized
EDRP Authorized: Former EDRP participants ineligible to apply for incentive.Contact VHAEDRPProgramSupport@va.gov, the EDRP Coordinator for questions/assistance. Learn more
Permanent Change of Station (PCS): Not Authorized

Salary : $56,715 - $200,000