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Abbott

Makes heart devices, glucose sensors and lab tests

Associate Program Director - Digital Solutions

Program ManagementConfirmed live in the last 24 hours
Full-time$148.7k - $297.3k

About the Job

Requirements

  • A bachelor's degree in a relevant field such as engineering, data science, or software is required.
  • At least 12 years of end-to-end program management experience within the medical device, biomedical, or life sciences industry with a global regulatory context is required.
  • Demonstrated experience with Design Controls processes compliant with ISO 13485 standards and 21 CFR 820 regulations is required.
  • Working knowledge of FDA 510(K) and/or EU MDR regulatory requirements is required.
  • Demonstrated experience in digital health product development processes is required.
  • Demonstrated success in risk management, change management, and strategic planning is required.
  • PMP certification and Agile training or certification are required.
  • Experience with project management tools, including Microsoft Office and Smartsheet, is required.
  • The ability to manage multiple projects simultaneously is required.
  • Strong organizational, leadership, and problem-solving skills are required.
  • Strong verbal and written communication and presentation skills, including the ability to communicate effectively with multiple organizational levels, are required.
  • The ability to influence and persuade while remaining results-oriented is required.
  • Experience with budgeting and financial tracking is required.

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.
  • 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 stakeholders and leadership.
  • Ensure alignment with organizational goals, quality standards, and best practices.
  • Facilitate meetings, maintain documentation, and ensure program governance.
  • Drive continuous improvement through lessons learned and process optimization.
  • Apply project management methodologies and best practices.
  • Prioritize and balance competing priorities across multiple projects simultaneously.
  • Work in a matrix management organization with primary responsibility for project success while relying on cross-functional team members who are not direct reports.
  • Ensure compliance with relevant digital health and software as a medical device (SaMD) standards and quality expectations, including quality management system and software lifecycle requirements, product safety and reliability expectations, labeling and instructions for use, and design control obligations under U.S. and international regulations.

Desired Qualifications

  • An MBA or other related advanced degree is preferred.
  • Familiarity with applying artificial intelligence technologies in a clinical setting is preferred.
  • Experience with interoperability standards, including FHIR, HL7, and SMART on FHIR, is preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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