Staff Research Scientist

Abbott seeks a Staff Research Scientist to lead design control and product development for regulated molecular diagnostic devices. The role involves managing the design history file, overseeing multifunctional teams through all development phases, and ensuring compliance with FDA and international quality standards.

Responsibilities

• Lead product development activities within FDA Design Control framework for class III medical devices
• Create, version, and manage Design and Development Plans and Design History File documentation
• Define project goals and deliverables aligned with strategic plans and regulatory timelines
• Oversee cross-functional teams through feasibility, development, verification, and validation phases
• Collaborate with Quality, Regulatory Affairs, Manufacturing, and Clinical Affairs to ensure regulatory compliance

Requirements

• Hands-on experience with PMA and/or IVD molecular diagnostics test development
• Expertise in FDA Design Control framework and ISO 13485, ISO 14971 standards
• Experience managing Design History Files and design review processes
• Demonstrated ability to lead cross-functional teams in regulated product development
• Strong technical writing and data interpretation skills for complex experimental analysis
• Knowledge of assay design, analytical validation, and clinical validation strategies