Description
Apply engineering and biomedical principles to plan, acquire, integrate, maintain, and evaluate medical devices and clinical systems in healthcare settings, ensuring patient safety, regulatory compliance, interoperability, and efficient care delivery.
- • Advise clinical leadership on technology planning, selection, and acquisition.
- • Evaluate the safety, performance, and clinical effectiveness of medical devices and systems.
- • Conduct acceptance testing and commissioning of new equipment.
- • Develop and oversee preventive maintenance, calibration, and performance verification programs.
- • Investigate device incidents and failures; perform root cause analysis and corrective actions.
- • Develop and maintain policies, SOPs, and standards for device use, maintenance, and repair.
- • Train clinicians and technical staff on safe and effective equipment use.
- • Manage the medical equipment inventory and CMMS, including UDI and device history records.
- • Ensure compliance with regulatory and accreditation requirements, such as FDA actions, The Joint Commission, and NFPA 99.
- • Coordinate recalls, safety alerts, and hazard notices with stakeholders.
- • Collaborate with IT to integrate devices with networks and EHR systems.
- • Assess and mitigate medical device cybersecurity risks and vulnerabilities.
- • Specify utility, space, and infrastructure requirements; oversee installations and upgrades.
- • Participate in value analysis, technology assessment, and capital budgeting.
- • Develop acceptance, functional, and performance test procedures and checklists.
- • Manage vendor relationships, service contracts, and service level agreements.
- • Monitor reliability, downtime, and maintenance metrics; report KPIs and compliance.
- • Standardize equipment across sites to improve safety and serviceability.
- • Support alarm management, human factors, and usability improvements.
- • Lead or support process improvement projects for device-related workflows.
- • Prepare technical reports, risk assessments, and documentation for audits and surveys.
- • Coordinate equipment decontamination, decommissioning, and compliant disposal.
- • Provide engineering consultation for clinical trials, research devices, or custom configurations.
- • Conduct environment-of-care rounds and risk assessments in patient care areas.
- • Review and approve purchase specifications, instructions for use, and service documentation.
- • Plan for emergency operations and surge capacity for critical equipment.
- • Maintain communication with manufacturers on design issues, upgrades, and field corrections.
- • Evaluate and implement test equipment, tools, and software for HTM operations.
- • Support compliance with applicable standards, such as IEC 60601, IEC 62353, IEC 80001, and ISO 14971.
- • Stay current with device technology, standards, and industry guidance.
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Advanced Manufacturing
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
