Biomedical Engineering & Medical Devices·Updated on Nov 11·
Full-timeIrving, TX, USANo salary listed
About the Job
Requirements
An associate's degree in electronics, biomedical equipment technology or a related field, or equivalent relevant biomedical service experience.
At least 5 years of biomedical or healthcare technology service experience, including at least 2 years of direct people leadership or equivalent team/site supervision.
Experience managing the daily workload of an established biomedical service operation, repair depot or comparable technical service environment.
Working knowledge of infusion pump and other medical device maintenance and repair, manufacturer service requirements, and medical device quality procedures.
Ability to manage work-in-progress, technician capacity and site expenses using measurable turnaround, quality and throughput data.
Comfort using computerized maintenance management systems (CMMS), service documentation and reporting tools to manage work-in-progress and identify data-quality gaps.
Ability to work onsite in Irving and travel occasionally.
Ability to stand and walk for extended periods and safely handle equipment, with reasonable accommodations as applicable.
Ability to follow infection-control procedures, personal protective equipment requirements and applicable workplace safety practices.
Responsibilities
Direct the Irving biomedical workflow, including receiving, cleaning, preventive maintenance, repair, final quality checks, shipping and rental-fleet readiness.
Use iQuest reporting and daily production reviews to manage turnaround time, open work orders, aging units, technician productivity, first-pass quality and customer service commitments.
Establish consistent service priorities, documented handoffs and escalation pathways; address bottlenecks, recurring rework and service-record discrepancies.
Balance available technicians, parts, test equipment and repair capacity against incoming demand; manage aging queues and prevent avoidable service delays.
Control approved site labor, overtime, parts, test equipment and operating expenses; recommend staffing or equipment investments supported by demand and performance data.
Ensure Irving biomedical activities follow IMS's ISO 13485:2016 Quality Management System, current manufacturer service requirements, and applicable safety and regulatory procedures.
Coordinate with Quality and Regulatory Affairs on audit readiness, CAPA execution, device recalls, nonconformances and customer complaints; ensure timely and documented site-level follow-through.
Maintain audit-ready iQuest records, equipment traceability, service documentation and calibration status; promptly correct inaccuracies and escalate compliance risks.
Recruit, train, coach and evaluate Irving biomedical technicians and site support staff in partnership with HR; clarify performance expectations and daily accountability.
Maintain technician training plans, OEM qualifications and documented competencies; develop coverage across preventive maintenance, repairs and other service lines to reduce single-person dependencies.
Direct work assignments, coach effective troubleshooting and manage technical escalations; assist with service work as appropriate to qualifications and operating needs.
Maintain a safe, organized and efficient shop; reinforce infection control, personal protective equipment, device segregation and 5S practices while resolving performance or conduct concerns with HR.
Serve as the Irving biomedical point of contact for service issues and customer escalations; coordinate with Sales, Customer Service, Field Service and internal logistics.
Support increased service volume, new equipment programs, OEM requirements and approved onsite service initiatives by forecasting site capacity and cross-functional resource needs.
Provide the Director of Biomedical Operations with timely site KPI, staffing, backlog, quality and customer-risk updates, along with action plans and requests for additional resources.
Work primarily onsite in the biomedical repair shop, with periodic office, warehouse and customer-site activity.
Travel occasionally, including overnight training or site visits, as business needs require.
Desired Qualifications
CBET, CHTM or other relevant biomedical/electronics certification.
Experience in home infusion, alternate-site care, equipment rental or high-volume infusion device service.
Familiarity with iQuest, P21 or comparable service/ERP systems, particularly work order aging and service production reporting.
Lean, Six Sigma, 5S or other documented process-improvement training.
The Biomedical Operations Manager – Irving leads daily biomedical service operations at IMS's Irving, Texas facility. This hands-on leader is accountable for staffing, service throughput, equipment readiness, documentation, quality and timely customer support at an established, high-volume service location. Working closely with the Director of Biomedical Operations and IMS support teams, the manager will stabilize daily execution, develop technicians, address backlogs and improve capacity as the Texas operation continues to grow.
Responsibilities
Site operations and performance
Direct the Irving biomedical workflow, including receiving, cleaning, preventive maintenance, repair, final quality checks, shipping and rental-fleet readiness.
Use iQuest reporting and daily production reviews to manage turnaround time, open work orders, aging units, technician productivity, first-pass quality and customer service commitments.
Establish consistent service priorities, documented handoffs and escalation pathways; address bottlenecks, recurring rework and service-record discrepancies.
Balance available technicians, parts, test equipment and repair capacity against incoming demand; manage aging queues and prevent avoidable service delays.
Control approved site labor, overtime, parts, test equipment and operating expenses; recommend staffing or equipment investments supported by demand and performance data.
Quality and compliance
Ensure Irving biomedical activities follow IMS's ISO 13485:2016 Quality Management System, current manufacturer service requirements, and applicable safety and regulatory procedures.
Coordinate with Quality and Regulatory Affairs on audit readiness, CAPA execution, device recalls, nonconformances and customer complaints; ensure timely and documented site-level follow-through.
Maintain audit-ready iQuest records, equipment traceability, service documentation and calibration status; promptly correct inaccuracies and escalate compliance risks.
People leadership
Recruit, train, coach and evaluate Irving biomedical technicians and site support staff in partnership with HR; clarify performance expectations and daily accountability.
Maintain technician training plans, OEM qualifications and documented competencies; develop coverage across PM, repairs and other service lines to reduce single-person dependencies.
Direct work assignments, coach effective troubleshooting and manage technical escalations; assist with service work as appropriate to qualifications and operating needs.
Maintain a safe, organized and efficient shop; reinforce infection control, PPE, device segregation and 5S practices while resolving performance or conduct concerns with HR.
Customers and growth
Serve as the Irving biomedical point of contact for service issues and customer escalations; coordinate with Sales, Customer Service, Field Service and internal logistics.
Support increased service volume, new equipment programs, OEM requirements and approved onsite service initiatives by forecasting site capacity and cross-functional resource needs.
Provide the Director of Biomedical Operations with timely site KPI, staffing, backlog, quality and customer-risk updates, along with action plans and requests for additional resources.
Requirements
Required
Associate's degree in electronics, biomedical equipment technology or a related field, or equivalent relevant biomedical service experience.
5+ years of biomedical or healthcare technology service experience, including 2+ years of direct people leadership or equivalent team/site supervision.
Experience managing the daily workload of an established biomedical service operation, repair depot or comparable technical service environment.
Working knowledge of infusion pump and other medical device maintenance and repair, manufacturer service requirements, and medical device quality procedures.
Ability to manage work-in-progress, technician capacity and site expenses using measurable turnaround, quality and throughput data.
Comfort using computerized maintenance management systems (CMMS), service documentation and reporting tools to manage work-in-progress and identify data-quality gaps.
Strong communication, coaching and customer-service skills; ability to work onsite in Irving and travel occasionally.
Preferred
CBET, CHTM or other relevant biomedical/electronics certification.
Experience in home infusion, alternate-site care, equipment rental or high-volume infusion device service.
Familiarity with iQuest, P21 or comparable service/ERP systems, particularly work order aging and service production reporting.
Lean, Six Sigma, 5S or other documented process-improvement training.
Physical Requirements and Work Environment
Work is primarily onsite in the biomedical repair shop, with periodic office, warehouse and customer-site activity.
Occasional travel, including overnight training or site visits, as business needs require.
Ability to stand and walk for extended periods and safely handle equipment, with reasonable accommodations as applicable.
Follow infection-control procedures, PPE requirements and applicable workplace safety practices.