Biomedical Equipment Manager

The Opportunity:

Universal Diagnostics (UDx) is seeking an Biomedical Equipment Manager to join our Lab Operations Team in the Dallas-Fort Worth, TX area. In this role, you will lead equipment operations through equipment readiness, scheduling, maintenance, calibration, qualification, and vendor service coordination for laboratory and manufacturing equipment. You will also lead equipment personnel, maintain required equipment documentation, and support operational readiness activities to help ensure equipment remains available, reliable, and ready for use as we continue scaling. You will work closely with cross functional teams, including Manufacturing, Assay Development, Automation, Quality, Facilities, IT, and Software to support ongoing laboratory and manufacturing activities.

How you’ll contribute:

• Lead daily equipment operations across laboratory and manufacturing areas
• Manage equipment readiness and scheduling to support study work, validation activities, manufacturing, and other operational priorities
• Oversee preventive maintenance, calibration, repairs, vendor service visits, and service agreements
• Coordinate equipment installation and qualification activities, including IQ, OQ, and PQ, in partnership with Quality, vendors, and internal teams
• Directly manage, coach, and develop equipment personnel
• Assign workloads, establish priorities, and ensure appropriate staffing coverage for planned and unplanned equipment activities
• Establish performance expectations, provide ongoing feedback, conduct performance evaluations, and address performance concerns as needed
• Support the recruitment, onboarding, training, and development of equipment personnel
• Assess equipment issues, coordinate troubleshooting, and escalate risks that may affect safety, data quality, capacity, or operational timelines
• Maintain accurate and complete equipment documentation, including qualification, calibration, maintenance, service, and equipment status records
• Provide routine reporting on equipment readiness, downtime, upcoming activities, open issues, and operational risks
• Support equipment selection, onboarding, relocation, upgrades, and retirement activities
• Collaborate with cross functional teams to establish equipment priorities and support laboratory and manufacturing operations

What you’ll bring:

• Bachelor’s degree in Biomedical Engineering, Engineering Technology, Life Sciences, or a related technical field, or an equivalent combination of education and relevant experience
• Minimum seven years of experience supporting laboratory, manufacturing, biomedical, or other technically complex equipment
• Minimum three years of direct personnel management experience, including workload management, coaching, performance evaluations, and employee development
• Experience supporting equipment within a regulated or quality-controlled environment such as GMP, GLP, CLIA, ISO 13485, or an FDA regulated medical device organization
• Experience with equipment qualification, calibration, preventive maintenance, repair coordination, scheduling, and vendor management
• Strong technical troubleshooting skills and the ability to assess equipment risks and service needs
• Strong organizational, leadership, and communication skills
• Ability to manage multiple priorities in a fast-paced laboratory and manufacturing environment
• Experience using an electronic quality system, computerized maintenance management system, or comparable equipment tracking platform preferred
• Proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint

What we´ll offer:

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off! 
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule 
• And more to come!