Program Director, Digital Solutions – Medical Devices

Thornton Tomasetti

Los Angeles (CA)

On-site

USD 149,000 - 297,000

Full time

4 days ago
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Benefits offered by this job

Free medical coverage
Strong retirement plan
Tuition reimbursement
Education benefit (FreeU)
Diversity & inclusion recognition

Job summary

Abbott is a global healthcare leader seeking an Associate Program Director, Digital Solutions, within the Medical Devices group in the United States. This role leads a portfolio of programs from initiation to commercialization, coordinating cross‑functional teams and managing budget, milestones, and risk across multiple projects.

The position emphasizes design controls, SaMD quality standards, and regulatory compliance with ISO 13485 and 21 CFR 820, plus FDA 510(K) / EU MDR familiarity.

Qualifications

  • Bachelor’s degree in relevant field (engineering, data science, software) required.
  • 12+ years of end-to-end program management in medical device/life sciences with global regulatory context.
  • Design Controls processes compliant with ISO 13485 and 21 CFR 820.
  • Working knowledge of FDA 510(K) and/or EU MDR requirements.
  • Digital Health product development experience.
  • PMP Certification or Agile training.
  • Experience with budgeting and financial tracking.

Responsibilities

  • Define program scope, objectives, and deliverables in collaboration with stakeholders.
  • Develop detailed program plans, schedules, and budgets.
  • Lead cross-functional teams to successfully deliver program outcomes.
  • Monitor progress, track milestones, and adjust plans as needed.
  • Identify risks and implement mitigation strategies.
  • Manage program resources including personnel and budget.
  • Communicate program status, updates, and risks to leadership.
  • Ensure alignment with quality standards and governance.
  • Facilitate meetings and maintain documentation.

Skills

Program management
Leadership
Regulatory compliance
Cross-functional leadership
Communication
Problem solving
Budgeting
Agile

Education

Bachelor’s degree in relevant field

Tools

MS Office
Smartsheets

Job description

Abbott is a global healthcare leader seeking an Associate Program Director, Digital Solutions, within the Medical Devices group in the United States. This role leads a portfolio of programs from initiation to commercialization, coordinating cross‑functional teams and managing budget, milestones, and risk across multiple projects.

The position emphasizes design controls, SaMD quality standards, and regulatory compliance with ISO 13485 and 21 CFR 820, plus FDA 510(K) / EU MDR familiarity.

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