Aimed at mid-to-senior level technical leaders who can manage complex equipment and personnel in a regulated environment.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Universal DX
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 Equipment Operations 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!
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.
Source: Universal DX careers