Biomedical Engineer
Synensys, LLC
- New York, New York, United States
- New York, New York, United States
About
The Biomedical Engineer / Clinical Engineer will provide subject matter expertise in patient safety and medical device management to support the VA’s Healthcare Technology Management (HTM) Program Office. This role is critical to ensuring compliance with patient safety goals, regulatory requirements, and industry standards across the Veterans Health Administration (VHA).
Key Responsibilities
Manage recall and safety alert programs for medical devices, including hazard investigations, ensuring compliance with
Safe Medical Devices Act (SMDA)
and
The Joint Commission (TJC)
requirements.
Conduct medical equipment management programs compliant with healthcare standards and regulatory agencies.
Support incident investigations involving medical equipment and develop preventive strategies to mitigate risks.
Collaborate with HTM Program Office and field-based stakeholders to implement best practices for patient safety and medical device reliability.
Provide expertise in networking protocols, information security, and computer-based medical systems as they relate to medical technology.
Assist in developing and maintaining Medical Equipment Management Plans (MEMPs) and related policies.
Ensure adherence to VA, federal, and international standards, including ISO requirements.
Required Qualifications
Education:
Bachelor’s degree or higher in Engineering OR Certification as a Clinical Engineer (CCE).
Experience:
5+ years of experience managing medical device recall and safety alert programs.
Demonstrated competency in medical device hazard investigations and compliance with patient safety goals.
Proven ability to communicate and collaborate effectively with technical and professional staff at all levels of a healthcare organization.
Technical Knowledge:
Computer-based medical systems, networking protocols, and information security principles.
Regulatory requirements and ISO standards applicable to medical technology.
Additional Information
Travel:
Up to 30 trips per year may be required (4–5 days per trip).
Security Clearance:
Background investigation and VA Contractor PIV badge required prior to commencement of work.
Performance Period:
Base period of 12 months with four 12-month option periods.
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Languages
- English
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