Technical Program Manager – Product Development (Molecular Diagnostics)

Summary
An innovative genomics and molecular diagnostics organization is seeking a Technical Program Manager to lead cross-functional execution of a next-generation diagnostic platform from concept through commercial launch. This role partners closely with engineering, assay development, software, operations, regulatory, and quality teams to drive planning, prioritization, and milestone delivery across a complex product development lifecycle. Ideal for a program leader experienced in IVD environments and phase-gate development frameworks. 🚀

Responsibilities

• Lead cross-functional program planning, scheduling, and execution across platform development activities
• Facilitate core team meetings, design reviews, and executive program updates
• Develop and maintain integrated program schedules including dependencies, critical path, and resource constraints
• Drive cross-discipline resource alignment and prioritization discussions
• Administer stage-gate product development processes and ensure timely completion of phase deliverables
• Identify program risks and implement mitigation strategies with functional stakeholders
• Track milestones and communicate program status to leadership
• Coordinate design verification, design transfer, and regulatory submission readiness activities
• Enable efficient decision-making through structured stakeholder communication
• Improve program management tools, templates, and operating processes

Requirements

• 6–8+ years of experience in technical program or project management supporting full product development lifecycles
• Strong experience operating within stage-gate / phase-gate environments
• Demonstrated success managing complex, multi-workstream technical programs
• Expertise in schedule development, resource planning, risk management, and critical path tracking
• Strong facilitation and stakeholder alignment skills across technical teams
• Experience with program management tools (MS Project, Smartsheet, Jira, or similar)
• Experience supporting IVD product development
• Familiarity with FDA 510(k), ISO 13485, and design controls preferred
• Technical fluency in molecular diagnostics or adjacent life sciences technologies
• PMP or equivalent certification a plus
• B.S. or M.S. in Engineering, Life Sciences, or related technical fiel