Patient Safety Expertise Biomedical Engineer / Clinical Engineer

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

The Patient Safety Expertise Biomedical Engineer / Clinical Engineer supports a comprehensive Healthcare Technology Management (HTM) program with a primary focus on medical device safety, regulatory compliance, and incident prevention. This role provides technical expertise in medical equipment performance, devicerelated risk mitigation, and the management of recalls, safety alerts, and hazard investigations.

This position is primarily remote. Some travel is involved-up to 30 short-duration trips per year.

The Veterans Health Administration (VHA) National Healthcare Technology Management (HTM) Program Office is headquartered at the VA Boston Healthcare System campus in Bedford, Massachusetts, with additional major centralized program offices and strategic support located in Washington, D.C., and Severna Park, Maryland.

Essential Job Functions:

• Manage and maintain a compliant medical device recall and safety alert program, ensuring timely investigation, documentation, and resolution in alignment with SMDA, TJC, and patientsafety requirements.
• Conduct medical device hazard investigations and support incident reviews, providing technical analysis and recommendations to prevent recurrence and improve systemwide safety.
• Support the medical equipment management program by ensuring adherence to regulatory, accreditation, and industry standards, including ISO and applicable healthcare requirements.
• Provide technical expertise on computerbased medical systems, device networking, interoperability, and information security considerations.
• Collaborate with clinical staff, HTM teams, and leadership to address medical device issues, improve safety processes, and strengthen organizational compliance.

Necessary Skills and Knowledge:

• Demonstrated skill in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of a healthcare organization.
• Knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology.
• Competency in conducting a medical equipment management program that is compliant with applicable healthcare standards and regulatory agencies.
• 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.
• Understanding of regulatory agencies' requirements, industry regulatory requirements and International Standard Organization standards.

Minimum Qualifications:

• Bachelor's degree or higher (or CCE certification)
• Minimum 5+ years of experience and demonstrated competency 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.
• Shall meet at least one of the following basic qualifications:
  • Experience within a medical center and Healthcare Technology Management (HTM)/ Biomedical Engineering department
  • Experience working in or with the Veterans Health Administration (VHA)
  • Understanding of VISN, VA medical center, and HTM/Biomedical Engineering department operations
• Requires to have a strong healthcare/HTM background, and VHA experience
• This position requires some travel, estimated at up to 30 trips per year, typically short duration and spread across the team.

Pay and Benefits

The annual salary range for this position is $95,000 to $101,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.