Senior Design Control Scientist — Molecular Diagnostics

Thornton Tomasetti; California, Northern (MO, KY); Hybrid; USD 114,000 - 228,000; Full time

Job summary

Abbott is seeking a Staff Research Scientist in California to lead the Design Control activities for regulated molecular diagnostic products. You will own DHF management, design reviews, risk management, and cross-functional collaboration to ensure FDA/ISO compliance across the product lifecycle.

The role requires deep expertise in PMA/IVD development, GMP/QSR standards, and the ability to mentor teams through feasibility to validation stages while coordinating with Regulatory, Quality, and

Qualifications

• PhD in Life Sciences or related field; or Master’s with 4+ years of experience.
• 8+ years in biology/chemistry with IVD/medical device exposure.
• Strong knowledge of PMA submissions and FDA Design Control.

Responsibilities

• Lead design control activities across the FDA Design Control framework, ensuring traceability throughout the development lifecycle.
• Manage Design History File documentation, design reviews, and risk management records.
• Coordinate with Regulatory, Quality, Manufacturing, and Clinical teams to support submissions.
• Prepare technical reports and validation summaries for internal reviews and regulatory submissions.

Skills

Molecular biology

Biochemistry

Cell biology

NGS

Bioinformatics

Regulatory knowledge

Project management

Leadership

Education

PhD in Life Sciences

Master’s in Life Sciences

Bachelor’s in Life Sciences

Tools

Microsoft Office

Job description

Abbott is seeking a Staff Research Scientist in California to lead the Design Control activities for regulated molecular diagnostic products. You will own DHF management, design reviews, risk management, and cross-functional collaboration to ensure FDA/ISO compliance across the product lifecycle.

The role requires deep expertise in PMA/IVD development, GMP/QSR standards, and the ability to mentor teams through feasibility to validation stages while coordinating with Regulatory, Quality, and