Senior Program Director, Digital Solutions

Abbott; Los Angeles (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Abbott Laboratories in Los Angeles seeks an Associate Program Director, Digital Solutions to organize and execute a portfolio of medical device programs from initiation to commercialization, leading cross-functional teams and reporting progress to senior leadership.

You will ensure compliance with ISO 13485 and 21 CFR 820, manage budgets and schedules, mitigate risks, and drive process improvements in SaMD. Requires 12+ years of program management, PMP/Agile, and strong communication.

Qualifications

• Bachelor’s degree in a relevant field.
• 12+ years of end-to-end program management experience in medical devices or life sciences with global regulatory context.
• Experience with Design Controls per ISO 13485 and 21 CFR 820.
• Working knowledge of FDA 510(k) and/or EU MDR requirements.
• Digital Health product development experience.
• Strong risk/change management and strategic planning.

Responsibilities

• Define program scope, objectives and deliverables with stakeholders.
• Develop detailed plans, schedules, budgets and allocate resources.
• Lead cross-functional teams to achieve program outcomes.
• Monitor progress, milestones and adjust plans as needed.
• Identify risks and implement mitigation strategies.
• Communicate status, risks and progress to leadership.
• Ensure compliance with SaMD standards and design controls.

Skills

Communication

Attention to detail

Adaptability

Self Starter

Leadership

Strategic thinking

Time management

Risk management

Education

Bachelor’s degree in engineering/data science/software

PMP Certification

Agile Training/Certification

Tools

MS Office

Smartsheets

Job description

Abbott Laboratories in Los Angeles seeks an Associate Program Director, Digital Solutions to organize and execute a portfolio of medical device programs from initiation to commercialization, leading cross-functional teams and reporting progress to senior leadership.

You will ensure compliance with ISO 13485 and 21 CFR 820, manage budgets and schedules, mitigate risks, and drive process improvements in SaMD. Requires 12+ years of program management, PMP/Agile, and strong communication.