Senior Program Manager (Diagnostics)

Location: US Remote or on-site in Boulder, Colorado

Salary: $119,000–$148,700 annually, plus additional compensation and benefits.

Company

hirify.global is a global cell-free DNA testing company focused on oncology, women’s health, organ health, molecular diagnostics, and personalized genetic testing.

What you will do

• Lead complex, cross-functional diagnostic and medical device product development programs.
• Coordinate core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations.
• Drive design reviews, phase exits, development milestones, clinical trial launch, First Patient In, and regulatory submission readiness.
• Translate product goals and regulatory requirements into plans, priorities, decisions, and execution milestones.
• Manage risks, dependencies, trade-offs, technical issues, and portfolio governance escalations.
• Author and review Design and Development Plans, DHF documentation, design review materials, change orders, and other development deliverables.

Requirements

• 5–7+ years of experience in program management, product development, or relevant functional leadership within diagnostics, medical devices, biotechnology, clinical laboratories, or life sciences.
• Significant experience leading complex product development programs in regulated environments.
• Practical knowledge of ISO 13485, IEC 62304, design controls, and medical device or IVD development processes.
• Experience with product requirements, risk documentation, verification and validation, design reviews, phase exits, and regulatory readiness.
• Experience supporting IDE, IVDR, 510(k), PMA, or equivalent regulatory submissions.
• Experience with assay, software, systems, NGS diagnostics, or MRD development; PMP certification is preferred.

Nice to have

• Experience supporting clinical trial execution through First Patient In.
• NGS diagnostics and/or MRD experience.
• PMP certification or equivalent.

Culture & Benefits

• Collaborative, high-accountability environment focused on quality and continuous improvement.
• Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
• 401(k) with company match.
• Paid time off, company holidays, pregnancy and baby bonding leave, wellness, work-life, commuter, and fertility care benefits.
• Additional compensation through hirify.global’s Total Rewards program.