Senior Program Director, Digital Solutions

Thornton Tomasetti; Northern (KY); Hybrid; USD 149,000 - 297,000; Full time

Job summary

Abbott is seeking an Associate Program Director for Digital Solutions in the U.S. This role leads cross-functional teams from inception to commercialization, ensuring milestones, budget, and regulatory compliance for SaMD products.

The position requires a deep background in medical devices, ISO-13485, 21 CFR 820, and FDA/EU MDR exposure, with strong leadership and communication skills to influence senior leadership and stakeholders.

Qualifications

• Bachelor’s degree in engineering, data science, software or related field.
• 12+ years of end-to-end program management experience in medical devices/biomedical/life sciences with a global regulatory context.
• Experience with Design Controls (ISO 13485 and 21 CFR 820), FDA 510(k) and EU MDR requirements.
• Demonstrated success in risk management, change management, and strategic planning.
• PMP certification and Agile training/certification preferred.

Responsibilities

• Define program scope, objectives, and deliverables in collaboration with stakeholders.
• Develop detailed program plans, schedules, and budgets.
• Lead cross-functional teams to deliver program outcomes on time and within budget.
• Monitor progress, risks, and mitigations; communicate status to leadership.
• Ensure compliance with SaMD quality, safety and regulatory standards.

Skills

Communication

Attention to detail

Adaptability

Self Starter

Leadership

Strategic thinking

Time management

Risk management

Education

Bachelor’s degree in relevant field

Tools

MS Office

Smartsheets

PMP Certification

Agile Training

Job description

Abbott is seeking an Associate Program Director for Digital Solutions in the U.S. This role leads cross-functional teams from inception to commercialization, ensuring milestones, budget, and regulatory compliance for SaMD products.

The position requires a deep background in medical devices, ISO-13485, 21 CFR 820, and FDA/EU MDR exposure, with strong leadership and communication skills to influence senior leadership and stakeholders.