Associate Program Director, Digital Solutions
About The Position
Abbott Medical Devices’ Digital Solutions organization leverages digitally enabled technology to increase patient access to care and provide customers with experiences that support improved patient outcomes. The Associate Program Director, Digital Solutions organizes and executes a portfolio of programs supporting the product development pipeline. This role leads cross-functional teams from program initiation through commercialization, delivering agreed milestones and outcomes within allocated budgets. It represents the program portfolio to senior leadership and reports progress, risks, mitigations, challenges, and proposed resolutions. The position operates in a matrix management organization, with primary accountability for project success and reliance on cross-functional team members who are not direct reports. It requires balancing multiple priorities and ensuring that digital health and software as a medical device (SaMD) programs meet relevant quality and regulatory expectations, including software lifecycle and quality management system requirements, product safety and reliability, labeling and instructions for use, and design controls under U.S. and international regulations.
Requirements
- Bachelor’s degree in a relevant field, such as engineering, data science, or software.
- 12 or more years of end-to-end program management experience in the medical device, biomedical, or life sciences industry with a global regulatory context.
- Demonstrated experience with design control 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 and Agile training or certification.
- Experience with project management tools, including MS Office and Smartsheets.
- Proven ability to manage multiple projects simultaneously.
- Strong organizational, leadership, and problem-solving skills.
- Strong verbal and written communication and presentation skills, including the ability to communicate effectively with multiple organizational levels.
- Ability to influence and persuade while remaining results-oriented.
- Experience with budgeting and financial tracking.
Nice To Haves
- MBA or another related advanced degree.
- Familiarity with applying AI technologies in a clinical setting.
- Experience with interoperability standards such as FHIR, HL7, and SMART on FHIR.
Responsibilities
- 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 and milestones, adjusting 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 senior 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.
- Lead for project success in a matrix organization, relying on cross-functional team members who are not direct reports.
- Ensure compliance with relevant digital health and SaMD standards and quality expectations, including quality management system and software lifecycle requirements, product safety and reliability, labeling and instructions for use, and U.S. and international design control obligations.
Benefits
- Career development opportunities with an international company.
- Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- Retirement savings plan with high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
