Staff Research Scientist

This position holds product development, quality, and regulatory skills to lead multifunctional teams through all phases of product development—from feasibility, development, and verification to validation—providing cross-functional leadership to technical and non-technical product development teams by defining product development goals and deliverables, including creation, management, and traceability of design inputs and outputs, oversight of design review activities, and management of the overall Product Development Plan and design history files.

The individual will partner closely with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, Program Management, and Product Management to ensure products are developed in compliance with FDA Design Control requirements, ISO 13485, ISO 14971, and applicable global regulatory standards.

Essential Duties Include, but are not limited to, the following:

• Lead overarching product development activities within the FDA Design Control framework, ensuring design inputs, design outputs, verification, and validation activities are appropriately defined, executed, and traceable throughout the development lifecycle for a class III medical device.
• Own the creation and versioning of the Design and Development Plan.
• Own creation, management, and traceability of Design History File (DHF) documentation, including design reviews, design freeze activities, risk management files, and other records required to demonstrate compliance with QSR, ISO 13485, and applicable global regulatory requirements.
• Apply hands-on experience with PMA and/or IVD molecular diagnostics test development, including assay design, analytical and clinical validation strategy, and the unique documentation and evidentiary requirements associated with PMA submissions.
• Define clear, realistic product development project/program goals and deliverables that align with strategic plans and regulatory submission timelines.
• Exercise independent judgment in developing methods, techniques, and evaluation criteria for design verification and validation activities, ensuring alignment with design control requirements.
• Provide scientific and technical leadership across all phases of product development — feasibility, development, verification, validation, and post-market — influencing decisions affecting project planning, experimental design, and design control documentation strategy.
• Provide oversight and management of one or more cross-functional project teams, ensuring design control deliverables are met at each phase gate.
• Represent R&D in project/program cross-functional core team meetings and design review boards; apprise senior management on project status, design control milestones, and regulatory submission readiness.
• Collaborate cross-functionally with Product Management, Program Management, Clinical Affairs, Regulatory Affairs, Quality, Manufacturing, and Clinical Testing Laboratory teams to ensure design control documentation and PMA/IVD development activities support new product launches and continuous improvement.
• Analyze and interpret complex, abstract experimental data; recommend alternative experiments or design changes to achieve technical specifications and close design control gaps.
• Prepare detailed technical reports, design control documentation, and validation summaries suitable for internal design reviews and regulatory submissions.
• Organize, present, and convey complex project information, design control status, and technical problems clearly in written and verbal formats to project teams, cross-functional partners, and senior management.
• Lead root cause analysis and risk-based investigations for technical and design control issues; recommend and document corrective courses of action.
• Stay current on regulatory, scientific, and technological developments relevant to molecular diagnostics, PMA pathways, and design control best practices; incorporate into new product development initiatives.
• Ensure teams consistently follow legal, ISO, and QSR documentation requirements throughout all phases of the product lifecycle.
• Mentor and train team members on design control processes, documentation practices, and PMA/IVD development requirements.
• Maintain meticulous attention to detail and rigorous record-keeping to support audit-ready design history files.
• Communicate effectively across a variety of formats to drive alignment on design control milestones and project priorities.
• Lead, manage, and prioritize initiatives independently in a fast-paced, entrepreneurial environment, adapting to ambiguous or changing requirements.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with Abbott Cancer Diagnostics' Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work on a mobile device, tablet, or in front of a computer screen for approximately 90% of a typical working day.
• Ability and means to travel between Abbott Cancer Diagnostics locations, up to 10% of working time, which may include overnight/weekend travel.

Minimum Qualifications

• PhD in Life Sciences, Chemistry, Mathematics, or related field; or Master’s degree in Life Sciences, Mathematics, or related field and 4 years of experience in lieu of PhD; or Bachelor’s degree in Life Sciences, Mathematics, or related field and 6 years of experience in lieu of PhD.
• 8+ years of industry or academia experience in biology and/or chemistry.
• 6+ years of experience in medical device/IVD, biotech, life science, or pharmaceutical industry.
• Deep knowledge of molecular biology, biochemistry, cell biology, next-generation sequencing (NGS), and related sciences.
• Bioinformatics knowledge related to nucleic acid analysis and assay development.
• Proficient in Microsoft Office to including Excel, Word, and Power Point.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 10+ years of industry or academic development experience in Life Sciences, Chemistry, or related field.
• 8+ years of experience in medical device/IVD, biotech, life science or related field
• Proven experience in IVD product development and FDA submissions.
• Previous experience as a project lead for a team of scientists.
• Deep understanding of design control, and risk management.
• Strong leadership and project management skills.
• Experience with Quality Management System preferred