Biomedical Equipment Operations Lead

Universal Diagnostics S.A.; Dallas (TX); Presencial; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO 22 days with carryover 10 days

Birthday off

Medical, dental, vision + life, STD, &

401(k) plans

Flexible work schedule

Company holidays

Descripción de la vacante

Universal Diagnostics seeks a Biomedical Equipment Manager to lead equipment operations for laboratory and manufacturing at the Dallas–Fort Worth area. You will drive readiness, calibration, and qualification activities, while coordinating with Quality, Manufacturing, and IT teams.

Strong leadership and GMP/ISO exposure are essential. Ideal candidates bring 7+ years of equipment support, 3+ years managing staff, and experience in regulated environments.

Formación

• Bachelor's degree in Biomedical Engineering, Engineering Technology, Life Sciences, or related field or equivalent experience.
• Minimum seven years supporting laboratory, manufacturing, biomedical, or other technically complex equipment.
• Minimum three years of direct personnel management experience.
• Experience in GMP/GLP/CLIA/ISO 13485 or FDA-regulated environments.
• Experience with equipment qualification, calibration, PM, repairs, scheduling, and vendor management.
• Strong troubleshooting skills and ability to assess equipment risks and service needs.
• Strong organizational, leadership, and communication skills.
• Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint).

Responsabilidades

• Lead daily equipment operations across laboratory and manufacturing areas.
• Manage equipment readiness and scheduling to support studies, validation, manufacturing, and other priorities.
• Oversee preventive maintenance, calibration, repairs, vendor service visits and service agreements.
• Coordinate installation and qualification activities (IQ/OQ/PQ) with Quality, vendors, and internal teams.
• Directly manage, coach, and develop equipment personnel.
• Assign workloads, set priorities, and ensure staffing coverage for equipment activities.
• Set performance expectations, provide feedback, conduct evaluations, and address issues.
• Assist with recruitment, onboarding, and training of equipment staff.
• Assess equipment issues, coordinate troubleshooting, and escalate risks.
• Maintain complete equipment documentation (qualification, calibration, maintenance, status).
• Provide routine reports on readiness, downtime, activities, open issues, and risks.
• Support equipment selection, onboarding, relocation, upgrades, retirement.
• Collaborate with cross-functional teams to align equipment priorities with operations.

Conocimientos

Leadership

Project management

GMP/GLP/ISO

Troubleshooting

Communication

MS Office

Educación

Bachelor's in Biomedical Engineering or related

Herramientas

CMMS / QMS systems

Descripción del empleo

Universal Diagnostics seeks a Biomedical Equipment Manager to lead equipment operations for laboratory and manufacturing at the Dallas–Fort Worth area. You will drive readiness, calibration, and qualification activities, while coordinating with Quality, Manufacturing, and IT teams.

Strong leadership and GMP/ISO exposure are essential. Ideal candidates bring 7+ years of equipment support, 3+ years managing staff, and experience in regulated environments.