Equipment Operations Manager

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

PTO 22 days with carryover 10 days

Birthday off

Medical, dental, vision + life, STD, &

401(k) plans

Flexible work schedule

Company holidays

Job summary

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.

Qualifications

• 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).

Responsibilities

• 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.

Skills

Leadership

Project management

GMP/GLP/ISO

Troubleshooting

Communication

MS Office

Education

Bachelor's in Biomedical Engineering or related

Tools

CMMS / QMS systems

Job description

About Our Company

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

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 elevate 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!

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.