R&D Project Leader (Medtech)

TL;DR

R&D Project Leader (Medtech): Leading the development and validation of automated immunodiagnostic products with an accent on assay design and lifecycle support. Focus on connecting assay performance with underlying biology and chemistry and managing technical deliverables within regulated design control environments.

Location: Stillwater, Minnesota, USA

Salary: $99,086–$136,244 annually

Company

hirify.global is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.

What you will do

• Lead the development and validation of immunodiagnostic assays from concept through design validation.
• Design, execute, and interpret experiments to support assay design, performance, and manufacturability.
• Manage project documentation and deliverables in compliance with Design Control, QSR, ISO, and GMP requirements.
• Provide technical leadership, including root cause analysis and troubleshooting of complex assay issues.
• Lead, mentor, and develop a team of 2–3 Scientists.
• Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, and Marketing.

Requirements

• BS in Biology, Biochemistry, or relevant science (10+ years exp), MS (7+ years exp), or PhD (5+ years exp).
• Experience in the medical device or diagnostics industry.
• Demonstrated experience in immunodiagnostic assay development.
• Strong understanding of immunology, protein chemistry, and automated immunoassay systems.
• Solid knowledge of Design Control and regulated product development processes.
• Excellent written and verbal communication skills for technical presentations.

Culture & Benefits

• Comprehensive health benefits, retirement and financial wellbeing plans.
• Eligibility for an annual incentive program based on performance.
• Entrepreneurial environment that enables speed, collaboration, and global impact.
• People-centered culture valuing accountability, inclusion, and continuous development.
• Flexible time off programs and wellbeing support.