Biomedical Engineer / LMDI SME

Biomedical Engineer / LMDI SME

Fully Remote - Based in USA

Guided by our principles of value generation, continuous innovation, customer-centricity, and vested collaboration, Blue Water Thinking proudly supports our Federal clients in achieving their Agency goals.

Founded by a decorated twenty-eight year Veteran of the United States Army, Blue Water Thinking understands and supports the mission of our Nation's war fighters, Veterans, their families and caretakers.

Leveraging our executive team's military experience and private and public sector consulting expertise, Blue Water Thinking takes an integrated "one-team" approach and brings to bear best-fit solutions, thought leadership, and grit to meet our client's transformational needs.

Fueled by our values of integrity, respect, professionalism, stewardship and customer service, the Blue Water Thinking team understands the power of the human connection, collaboration, humility and loyalty to one another, our clients and industry partners.

Lastly, our formula for success is simple: Build something good, take care of our people, keep our clients satisfied, nurture our work ethic and reputation, build long-lasting partnerships, enjoy what we do and give back as much as possible.

We are seeking an experienced and highly qualified Biomedical Engineer to join our healthcare organization. As a Biomedical Engineer, you will play a pivotal role in managing our medical equipment program and ensuring the safety, functionality, and compliance of medical technology within our healthcare facility. The ideal candidate will have a minimum of three years of hospital or healthcare experience in medical equipment maintenance or management and possess a deep understanding of computer-based medical systems, networking protocols, information security, and healthcare standards and regulations.

*Travel associated with this role will consist of being away for about a week every 2 months*

Develop and implement a comprehensive medical equipment management program that complies with applicable healthcare standards, regulatory agencies, and industry best practices.

Create and deliver a curriculum for a continuing education program focused on the safe and effective use of medical technology for healthcare staff.

Manage a recall and safety alert program for medical devices, including conducting medical device hazard investigations, to ensure compliance with patient safety goals, SMDA (Safe Medical Devices Act), and TJC (The Joint Commission) requirements.

Lead capital asset and infrastructure planning for medical equipment, covering initial concept, installation, and effective implementation of complex medical technology.

Serve as the subject matter expert in the field of biomedical engineering, providing direct support for specialized clinical technology, including service, system administration, training, quality assurance, and life-cycle management.

Advise clinical and administrative staff on medical technology, including existing and emerging technology, to assess viability, long-term suitability, compatibility, and safety.

Apply project management principles to the deployment of medical equipment and health information technologies, ensuring timely and effective implementation.

Collaborate with key stakeholders, including technical and professional staff at various levels of the organization, to ensure seamless integration of medical technology.

Stay updated on regulatory agencies' requirements, industry regulatory standards, and International Standard Organization (ISO) standards to maintain compliance and drive continuous improvement.

The Contractor key personnel shall meet one of the following basic qualifications, regardless of role in the services provided under this contract:

• Experience within a medical center and Biomedical Engineering department
• OR, Experience working in or with the Veterans Health Administration (VHA)
• OR, Understanding of VISN, VA medical center, and Biomedical Engineering department operations

In addition to the basic qualifications, the Contractor key personnel shall meet the following role-specific qualifications based on the core functions and services each will be providing under this contract.

• A Bachelor's degree or higher in Engineering or Certification as a Clinical Engineer (CCE).
• 5+ years experience as a Hospital-based BME or a Field Service Engineer with extensive laboratory experience. Major laboratory vendor (e.g., Abbott, Roche, Beckman Coulter etc.) experience preferred.
• Strong knowledge and familiarity with laboratory management systems, both General Lab and Point-of-Care. Knowledge of Data Innovations Instrument Manager, Abbott RALS and Siemens UniPOC highly desirable.
• Experience with Oracle Health (formerly Cerner) EHR, strong experience with Oracle Health (CareAware) MDI and PathNet required.
• Demonstrated knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology within VHA.
• Demonstrated competency in the ability to conduct a medical equipment management 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; 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; to apply project management principles to deployment of medical equipment and health information technologies.
• Demonstrated skill in in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of the organization.
• Understanding of regulatory agencies' requirements, industry regulatory requirements and International Standard Organization standards.

Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future

Must be able to obtain and maintain the required federal public trust clearance for this role

Must provide proof of Flu vaccination during flu season, or, as an alternative, appropriate documentation that will support either a medical or religious exemption.

Salary for this position is determined by various factors, including but not limited to, location, the candidate's particular combination of knowledge, skills, competencies and experience, as well as contract specific affordability and organizational requirements. The proposed salary range for this position is outlined below.

Salary range: $90,000 - $120,000

Blue Water Thinking offers a comprehensive benefits package including health insurance (medical, dental and vision), paid time off, federal holidays, and matching 401K plan.

Blue Water Thinking is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the application and hiring process. If you require a reasonable accommodation to search for a position, complete an application, or participate in the interview process, please contact Resource Management at View email address on click.appcast.io. Requests for accommodation will be handled promptly and confidentially in accordance with applicable law.

Blue Water Thinking is an Equal Opportunity Employer. We recruit, hire, train, and promote qualified individuals without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

Resume must be submitted in word document format and must include dates in each section (experience, education, certifications...)

Candidates must fill out the below form to the best of their knowledge