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Greenberg & Larraby, Inc. · 18 hours ago

Biomedical Engineer

Bethesda, MD

Full-time

Hybrid

Senior Level, Lead/Staff

20+ years exp

Greenberg-Larraby, Inc. (GLI) is searching for an innovative and motivated Biomedical Engineer to join their dedicated engineering team with a well-known government agency. The role involves designing, developing, and maintaining medical devices and technologies to enhance patient care and safety.

Management Consulting

No H1B

U.S. Citizen Only

Responsibilities

Conduct research and development on medical devices and technologies

Design, test, and validate biomedical equipment to meet high safety and effectiveness standards

Ensure compliance with FDA regulations and industry standards

Collaborate with multi-disciplinary teams to solve engineering challenges

Provide technical support and training for clinical staff on new technologies

Participate in project management and assist in budget planning for engineering projects

Qualification

Biomedical EngineeringCertified Clinical Engineer (CCE)Medical device industry experienceComputer-based medical systemsNetworking protocolsInformation securityMedical equipment managementRegulatory complianceIncident investigationPatient safety knowledgeCollaboration skillsProject management

Required

Master's degree or higher in Biomedical Engineering or a related field

Relevant experience in the medical device industry

U.S. Citizenship

20+ years hospital / healthcare experience: Maintaining medical equipment, Managing a hospital medical equipment program

20+ years working collaboratively with: Clinical staff, Technical staff, Executive / leadership stakeholders

10+ years conducting incident investigations involving medical equipment, Including development of system-wide guidance

Technical & Regulatory Expertise in Computer-based medical systems, Networking protocols, Information security as applied to medical technology, Medical equipment management programs compliant with: Healthcare standards, Regulatory agencies

Recall and safety alert management, Medical device hazard investigations, Patient safety goals, SMDA, TJC requirements

Strong understanding of: Federal and industry regulatory requirements, ISO standards