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 requirements
o Product safety and reliability expectations
o Labeling and instructions for use
o 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
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The base pay for this position is $148,700.00 – $297,300.00. In specific locations, the pay range may vary from the range posted.
