Associate 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

## Associate Program Director, Digital SolutionsCandidatar-se: United States - California - Sylmar: Tempo Integral: Publicado hoje: 31164560Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.Descritivo de Cargo**Working at Abbott**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:* Career development with an international company where you can grow the career you dream of* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.* An excellent retirement savings plan with high employer contribution* Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree* A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientistsAbbott Medical Devices, with revenue of $21B in 2025, is a global leader in providing life changing technology for the management and treatment of people living with chronic conditions including diabetes, cardiovascular disease, chronic pain, and movement disorders.The Digital Solutions organization reports in the Medical Devices group and is responsible for leveraging digitally enabled technology to increase patient access to care and provide our customers with best-in-class experiences that support our collective mission to improve patient outcomes. The ***Associate Program Director, Digital Solutions*** is responsible for organizing and executing a portfolio of programs to support the product development pipeline. The role is responsible for leading cross-functional teams from program initiation to commercialization to meet agreed milestones and deliverables within the program’s allocated budget. The role serves as the face of the program portfolio while including reporting core team progress, risks/mitigations, key challenges and proposed resolutions etc, to senior leadership.**Key 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 effectively, 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 multiple competing priorities within and across multiple projects at the same time.· Work in a matrix management organization with primary responsibility for project success while relying on cross-functional team members, which are not direct reports.· Ensure compliance with all relevant standards and quality expectations for digital health and software as a medical device (SaMD), including:o Quality management system and software lifecycle requirementso Product safety and reliability expectationso Labeling and instructions for useo Design control obligations under both US and International regulations**Key Competencies**· Communication· Attention to detail· Adaptability and resilience· Self Starter· Leadership and team collaboration· Strategic thinking and decision-making· Time management and prioritization· Risk management**Required Qualifications**· Bachelor’s degree in relevant field (e.g., engineering, data science, software)· 12+ years of end-end program management experience within a medical device/biomedical/life sciences industry with a global regulatory context· Demonstrated experience of Design Controls processes, compliant with ISO 13485 standards and 21 CFR 820 regulations· Working knowledge of FDA 510(K) and/or EU MDR regulatory requirements· Demonstrated experience in Digital Health product development processes· Demonstrated success in risk management, change management, and strategic planning* PMP Certification, Agile Training/Certification* Experience with Project management tools (MS Office, Smartsheets)· Proven ability to manage multiple projects simultaneously· Strong organizational, leadership, and problem-solving skills· Strong verbal and written communication and presentation skills with ability to effectively communicate with multiple levels in the organization· Ability to influence and persuade while remaining results orientated· Experience with budgeting and financial tracking**Preferred Qualifications**· MBA or other related advanced degree· Familiarity with application of AI technologies in a clinical setting· Experience with interoperability standards (FHIR, HL7, SMART on FHIR) **Apply Now****Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. **The base pay for this position is**$148,700.00 – $297,300.00