Principal Program Manager

The Opportunity:

Universal DX is seeking a highly experienced program manager to join our growing Program Management team. Reporting to the Director, Program Management, this role will partner closely with Assay Development, Reagent Development, and Pre-Analytical Development to translate scientific and product strategy into executable plans. The role will serve as the primary program-management bridge between wet-lab Product Development and Automation, Software Development, Quality, Regulatory, Lab Operations, Manufacturing, Supply Chain, and other cross-functional partners supporting development and commercialization of Universal DX IVD products.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”. 

How you'll contribute:

• 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, success criteria, resources, budgets, timelines, and decision points.
• Connect wet-lab plans with automation and software development, ensuring requirements, interfaces, dependencies, and verification activities remain aligned.
• Coordinate with Quality, Regulatory, Lab Operations, Clinical, Manufacturing, and Supply Chain so design-control and operational deliverables are incorporated into the program plan.
• Proactively identify planning gaps, technical and execution risks, and change impacts; develop options and mitigation plans and escalate with clear recommendations.
• Facilitate cross-functional working sessions and workstream meetings; document decisions, actions, owners, and due dates and drive timely closure.
• Maintain integrated schedules, dashboards, and executive-ready reporting, while mentoring PM colleagues and strengthening consistent planning practices across Product Development.

What you'll bring:

• Bachelor's degree in biology, chemistry, biotechnology, bioengineering, or a related scientific or engineering discipline; an advanced degree is preferred.
• Eight or more years of relevant experience in diagnostics, medical devices, or life science product development, including substantial responsibility for complex cross-functional programs.
• Direct IVD product development experience gained either as a scientist or technical lead who has driven program execution, or as a program manager dedicated to Product Development functions.
• Demonstrated experience supporting wet-lab product development functional areas and working cross-functionally with other functions. 
• Strong working knowledge of regulated product development, design controls, risk management, verification and validation, and design history file deliverables under an ISO 13485 quality system.
• Ability to understand scientific and technical content, ask effective questions, research alternatives, and translate complex work into clear plans and decisions.
• Strong facilitation, stakeholder management, written communication, and executive presentation skills, with the ability to influence without direct authority.
• Proficiency with program management methods and tools; experience with Smartsheet, Jira, Confluence, and Microsoft 365 and a PMP or similar certification are highly preferred.

What we'll offer:

We’re proud to offer exceptional corporate benefits which include:

• 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!