Program Director, Digital Solutions (Medical Devices)

Abbott; Los Angeles (CA); Sur place; USD 180 000 - 230 000; Plein temps

Résumé du poste

Abbott is seeking an Associate Program Director, Digital Solutions to organize and execute a portfolio of programs supporting product development, from initiation to commercialization. Lead cross-functional teams, manage budgets, and report progress to senior leadership while ensuring compliance with SaMD quality and regulatory standards.

The role requires extensive program management experience in medical devices, strong leadership, and the ability to navigate global regulatory contexts.

Qualifications

• Bachelor’s degree in engineering, data science, software, or related field.
• 12+ years end-to-end program management in medical device/biomedical/life sciences with global regulatory context.
• Design Controls experience compliant with ISO 13485 and 21 CFR 820.
• Working knowledge of FDA 510(K) and/or EU MDR regulatory requirements.
• Digital Health product development experience.
• Risk management, change management, and strategic planning experience.
• PMP Certification and Agile training.
• Experience with MS Office and Smartsheets.
• Ability to manage multiple projects simultaneously.
• Strong organizational, leadership, and communication skills.

Responsabilités

• Define program scope, objectives, and deliverables with stakeholders.
• Develop detailed program plans, schedules, and budgets.
• Lead cross-functional teams to deliver program outcomes.
• Monitor progress, track milestones, and adjust plans.
• Identify risks and implement mitigation strategies.
• Communicate program status, updates, and risks to leadership.
• Ensure alignment with quality standards and regulatory requirements for SaMD.
• Drive continuous improvement through lessons learned and process optimization.
• Apply project management methodologies and best practices.
• Prioritize and balance multiple projects in a matrix organization.

Connaissances

Cross-functional leadership

Communication

Leadership

Strategic thinking

Risk management

Time management

Attention to detail

Problem solving

Change management

Project management

Formation

Bachelor’s degree in engineering or related field

PMP Certification

Agile Certification

Regulatory knowledge (FDA/ISO)

Outils

MS Office

Smartsheets

Description du poste

Abbott is seeking an Associate Program Director, Digital Solutions to organize and execute a portfolio of programs supporting product development, from initiation to commercialization. Lead cross-functional teams, manage budgets, and report progress to senior leadership while ensuring compliance with SaMD quality and regulatory standards.

The role requires extensive program management experience in medical devices, strong leadership, and the ability to navigate global regulatory contexts.