Scientific and Technical Leadership

Strong foundation in life sciences, diagnostics, or biomedical engineering with proven leadership in assay, reagent, or device development.

Product Development Lifecycle Knowledge

Deep understanding of IVD development stages from concept through feasibility, design verification, validation, and tech transfer.

Innovation & Pipeline Strategy

Ability to define R&D strategy, evaluate new technologies, and prioritize projects to meet commercial and regulatory needs.

Regulatory & Quality Alignment

Familiar with FDA QSR, ISO 13485, IVDR/MDR regulations; integrates compliance into design and development processes.

Cross-Functional Program Management

Leads interdisciplinary teams across R&D, Regulatory, QA, Clinical, and Operations to deliver projects on-time and on-budget.

People Leadership & Mentoring

Builds and motivates high-performing scientific teams, fosters innovation culture, and mentors junior scientists or engineers.

Data-Driven Decision Making

Uses analytical rigor to interpret experimental data, make go/no-go decisions, and adjust project direction as needed.

Grant-Funded Research Experience

Experience securing or collaborating on federally funded R&D projects (e.g., NIH, BARDA) is a strong plus.

At least 10 years of total professional experience.

An average of 30 months or more

Experience in IVD (In Vitro Diagnostics)

Fewer than 7 companies.

There are successful cases of applying for government subsidies

PhD in a relevant life sciences or IVD-related field

PTO

Medical insurance

401K