Biomedical Engineer / Clinical Engineer (Patient Safety Expertise)

Aptive Resources is seeking a Biomedical Engineer / Clinical Engineer with Patient Safety Expertise to support the Department of Veterans Affairs. This role focuses on enhancing patient safety and managing medical device risks across VA healthcare facilities by evaluating recalls, safety notices, and incident investigations.

Responsibilities:

• Assist in evaluating and responding to medical device recalls, safety notices, and adverse events, helping ensure appropriate mitigation strategies are identified and communicated across the enterprise
• Support investigations into equipment-related incidents, contributing to documentation and reporting, and ensuring alignment with patient safety goals and applicable regulatory and accreditation standards

Requirements:

• Bachelor's degree or higher in Engineering or Certification as a Clinical Engineer (CCE)
• 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
• 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