Staff Research Scientist

Abbott (abbottcareers2 board); San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Abbott is a global healthcare leader driving innovation in diagnostics and life sciences. The Staff Research Scientist leads design control, DHF management, risk assessment, and regulatory strategy for regulated molecular diagnostics products across development stages.

In this role you will partner with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Product Management to ensure adherence to FDA Design Control, ISO 13485, and ISO 14971, delivering robust design history

Qualifications

• Experience with FDA Design Control, ISO 13485, andISO 14971 regulatory standards.
• Proven ability to lead cross-functional product development teams.
• Strong understanding of PMA/IVD molecular diagnostics documentation.

Responsibilities

• Lead product development activities within FDA Design Control for class III devices.
• Own Design and Development Plan creation and updates.
• Manage Design History File (DHF) documentation and design reviews.
• Oversee risk management files and regulatory submission readiness.
• Guide verification, validation, and design transfer activities.
• Collaborate with R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Product Management.
• Represent R&D in cross-functional core teams and design review boards.

Skills

Design Control

Cross-functional

Regulatory

Risk Management

Leadership

Education

Master's or PhD in life sciences or engineering

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Position Overview

The Staff Research Scientist is a Design Control lead responsible for leading, managing, executing, and completing projects associated with developing new regulated molecular diagnostic products and lifecycle management of existing products, serving as the primary leader for Design History File (DHF) management, requirements traceability, design reviews, risk management documentation, and phase-gate governance throughout the product development lifecycle. 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, exercising judgment and making informed decisions using broadly defined practices and procedures to determine appropriate action or select methods, techniques, and evaluation criteria for obtaining solutions, while supporting a collaborative environment aligned with Abbott Cancer Diagnostics' mission.

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, Qualit