Senior Program Manager, Diagnostics & Cross-Functional Delivery

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

22 days PTO with carryover

Birthday off

Medical, dental, vision + life, STD, &

Job summary

Universal DX, Inc. seeks a highly experienced Program Manager to join our growing team.

You will translate scientific and product strategy into executable plans, bridging wet-lab development with automation, software, and QA, Regulatory, Manufacturing, and Supply Chain to drive the IVD product lifecycle. You will lead cross-functional workstreams, define scope and timelines, and maintain integrated schedules with executive-ready reporting.

Qualifications

• Bachelor's degree in biology, chemistry, biotechnology, bioengineering, or related field; advanced degree preferred.
• Eight+ years of experience in diagnostics, medical devices, or life science product development with cross-functional program responsibility.
• Experience in IVD product development as scientist/lead or program manager.
• Experience supporting wet-lab product development and cross-functional collaboration.
• Strong knowledge of regulated development, design controls, risk management, V&V, and DHF under ISO 13485.
• Ability to translate scientific content into clear plans and decisions.
• Strong facilitation, stakeholder management, and executive presentation skills; PMP preferred.

Responsibilities

• Lead integrated planning and support execution for assay, reagent, and pre-analytical development workstreams across the IVD product lifecycle.
• Partner with scientific and functional leads to define scope, deliverables, budgets, timelines, and decisions.
• Connect wet-lab plans with automation and software development, ensuring alignment of requirements and interfaces.
• Coordinate with Quality, Regulatory, Lab Ops, Clinical, Manufacturing, and Supply Chain to include design-control deliverables in the plan.
• Identify planning gaps, risks, and changes; develop options and mitigation plans with recommendations.
• Facilitate cross-functional sessions; document decisions, actions, owners, and due dates with timely closure.
• Maintain integrated schedules, dashboards, and executive-ready reporting; mentor PMs and standardize planning practices.

Skills

Biology degree

Diagnostics experience

ISO 13485 knowledge

PMP certification

Cross-functional leadership

Program management tools

Education

Bachelor's degree in biology/biotech/related

Advanced degree preferred

Tools

Smartsheet

Jira

Confluence

Microsoft 365

Job description

Universal DX, Inc. seeks a highly experienced Program Manager to join our growing team.

You will translate scientific and product strategy into executable plans, bridging wet-lab development with automation, software, and QA, Regulatory, Manufacturing, and Supply Chain to drive the IVD product lifecycle. You will lead cross-functional workstreams, define scope and timelines, and maintain integrated schedules with executive-ready reporting.