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

Duties

Duties will vary based on grade. At the GS-12 level, duties will include, but are not limited to: Play a critical role in planning, developing, and influencing implementation of quality, regulatory, and medical device design projects that support the success of VA Ventures. Participates on medical device product development projects as the representative of the quality function. Generates framework for evaluating risk and formalizing risk management plans, participates with development and process engineering in analyzing failure modes and effects, hazard analysis and, estimation of risks to patients and users of medical devices developed by VA Ventures. Advises development team on the product development process and ensures that design verification activities confirm that the design output meets the design input for the project. Executes quality oversite of production and process controls in accordance with established standard operating procedures. Runs and maintains existing processes for the maintenance and control of inspection, measuring, and test equipment used for acceptance activities. Strategic planning for operations; monitors emerging technologies, anticipates future demands and how to meet them. Assists other sites in setting up manufacturing facilities. Conducts internal audits. 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). Collaborates with clinical staff members to gather user needs for 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. Responsible for control of quality records using existing processes. Serves as a product manufacturing technical expert 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. Provides guidance on the use of statistical techniques used for incoming acceptance activities, validation of equipment, and final acceptance activities within existing procedures. Ensures that existing procedures are followed to identify, segregate, and disposition materials and equipment that do not conform to quality specifications. Participates in the material review board controlling the disposition of non-conforming materials. Provides engineering expertise and advice to VA Ventures strategic planning teams. Requires 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. Provides guidance to technical personnel at VA Ventures on the FDA's quality system regulation and what the appropriate SOP is to show compliance with the regulation. Contributes to the advancement of VA Ventures technology through independent research and written and oral presentations. Can run and maintain a medical device continuous improvement program, Corrective and Preventative Actions (CAP A), within an established framework. Identifies when corrective actions are warranted and can identify the appropriate SME as investigator. Can run and maintain a medical device supplier selection and control procedure. Evaluate and select potential suppliers, contractors, and consultants based on their ability to meet specified requirements, including quality requirements. Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results. Provide oversite and assistance to purchasing and operations to ensure that VA Ventures establishes and maintains records of acceptable suppliers, contractors, and consultants. Work Schedule: Monday - Friday, 7am - 5pm (hours negotiable) Telework: AD-HOC Virtual: This is not a virtual position Functional Statement #: 000000 Relocation/Recruitment Incentives: Not authorized EDRP Authorized: Contact [email protected] for questions/assistance. Learn more Permanent Change of Station (PCS): Not authorized Financial Disclosure Report: Not required

Requirements

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. Education and/or Experience: The individual must meet either item (1) or (2) below to meet this requirement: 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 Certification as a Certified Clinical Engineer (CCE) and a bachelor's degree not listed in item 3.b.(1) above. English Language Proficiency: Biomedical Engineers must be proficient in spoken and written English in accordance with chapter 2, section D, paragraph 5a, this part. 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: GS-7 (Entry Level) Experience: None beyond the basic requirements. Education: Bachelor's degree as outlined in paragraph 3.b.(1), above, or CCE certification with at least a bachelor's degree not listed in paragraph 3.b.(1). Demonstrated Knowledge, Skills, and Abilities: None beyond the basic requirements. Assignment: Employees serve in an entry level biomedical engineer career development position. It is expected that biomedical engineers at the entry level receive ongoing guidance from more experienced staff members and perform assignments under close supervision. GS-9 (Developmental Level 1) Experience: At least one year of specialized experience equivalent to the next lower level. Education: Master's degree in Biomedical Engineering, or a related field of study, as outlined in paragraph 3.b.(1). OR Bachelor's degree, as outlined in paragraph 3.b.(1), plus two full years of progressively higher level graduate education in a related field of study, provided the applicant's total background demonstrates the KSAs for the GS-9 level assignment. In addition the candidate must demonstrate all of the following KSAs: Knowledge of the principles, theories, concepts, and practices of the Biomedical Engineering profession. Ability to interpret relevant codes, regulations, guidelines, and standards, and make recommendations to ensure compliance with medical center programs. Ability to understand the operational needs of clinical services in the health care system. 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 Assignment: Biomedical Engineers, at this developmental level, require direction on more complex tasks. Employees complete technical assignments in the engineering field, under the direction of a senior biomedical engineer and will be required to rotate through, and participate in, the operations of other hospital services. At the GS-9 grade level, employees function with oversight by a supervisor for more complex assignments. 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. Education: Ph.D., or equivalent doctoral degree in Biomedical Engineering, or a related field of engineering, as outlined in paragraph 3.b.(1). OR Bachelor's degree, plus three full years of progressively higher level graduate education in a related field of study, as outlined in paragraph 3.b.(1). In addition the candidate must demonstrate all of the following KSAs: 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. 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. 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. Knowledge of basic project management principles, as applied to the healthcare setting and medical equipment, and information system implementation. Assignment: At the developmental level, employees function on a semi-independent basis with limited oversight by senior biomedical engineers. They participate in medical device hazard investigations, to assure compliance with patient safety goals, the Safe Medical Devices Act (SMDA), TJC requirements, and assist in the development of an equipment management program at the medical center. Employees may lead medical technology deployments, directly support medical equipment, or participate in research projects. 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. In addition the candidate must demonstrate all of the following KSAs: Ability to conduct a medical equipment management or biomedical research program that is compliant with applicable healthcare standards and regulatory agencies. Ability to develop a curriculum for a continuing education program, that address the safe and effective use of medical technology, and/or research devices. 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. Ability to conduct capital asset and infrastructure planning for medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment. 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. 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. Knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology within VHA. Skill in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of the organization. Ability to apply project management principles to deployment of medical equipment and health information technologies. References: VA Handbook 5005/104 Part II Appendix GS38 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: This work requires moderate lifting (15-44lbs), moderate carrying, use of fingers, both hands required, walking, standing, repeated bending, CONTINUED IN EDUCATION SECTION

Education

Physical Requirements Continued: operation of vehicle, 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), mental and emotional stability. Environmental factors are working outside and inside, constant noise, dust, working closely with others, and working alone.

IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on 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: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address VA Puget Sound Health Care System 1660 South Columbian Way Seattle, WA 98108 US
• Name: Rebecca Hanson
• Phone: 509-434-7320
• Email: [email protected]