Digital Program Manager

We're seeking a Digital Program Manager with a strong software delivery mindset to lead planning, orchestration, and delivery across all digital application development platforms-including mobile, web, embedded systems, and eCommerce. This role will establish structured project work breakdowns that roll up into resource plans, department roadmaps, and milestone tracking. You will manage projects through product development phase gates, ensuring deliverables and timelines are met, while coordinating with internal teams and vendor partners. Responsibilities include resource planning, budget management, and risk mitigation to keep initiatives on time and on budget.

You will own project and release roadmaps, synchronize work across cross-functional teams, and ensure compliance with internal processes and regulatory expectations throughout the lifecycle. This role will collaborate closely with the overall R&D Program Manager to ensure that digital initiatives are integrated into the broader organizational roadmap, align dependencies across other projects, and manage shared resources and timelines. You'll bring structure and momentum into a fast-changing environment, adapting your contributions to the evolving needs of the department.

Adaptability and flexibility are essential as priorities evolve. You'll bring clarity and momentum to a dynamic environment, aligning digital initiatives with organizational goals.

Portfolio Delivery & Roadmapping

• Organize and manage multiple concurrent digital and software initiatives across mobile, web, embedded, and eCommerce platforms.
• Develop and maintain project work breakdown structures that roll up into resource plans and department-level roadmaps.
• Maintain project and release roadmaps; align work to team capacity and support resource planning and timely adjustments to hit milestones.

Partner with Program Management and the R&D Program Manager to synchronize stage-gate plans, risks, and interdependencies (software hardware/production).Phase-Gate & Release Management

• Drive adherence to product development phase gates; ensure deliverables meet quality and regulatory expectations.
• Coordinate releases for non-regulated web apps and SaMD; define clear criteria, stakeholder alignment, cutover plans, and communications.
• Coordinate software dependencies that intersect with hardware/production, while hardware/firmware execution is led by the R&D PM.

Regulatory, QMS & Documentation

• Operate within internal processes (e.g., PDP/stage-gate) and ensure adherence to the Quality Management System (QMS) and relevant regulations (e.g., 21 CFR 820, ISO 13485).
• Maintain a documentation matrix/checklist per release (e.g., SDS, SRS, cybersecurity documentation, DCRs, user guides), tracking: needed? updated? reviewed/approved? published?
• Support/coordinate activities related to FDA submissions for SaMD (e.g., preparing content, aligning evidence, managing timelines) in partnership with Regulatory Affairs.

Resource & Budget Management

• Build and maintain staffing plans across internal teams and vendor partners.
• Manage budgets and financial tracking to ensure projects remain on time and on budget.

Vendor & Partner Coordination

• Engage and manage vendor partners as needed for specialized development or integration work.
• Ensure contractual deliverables and timelines are met.

Cross-Functional Leadership

• Work closely with engineering leadership, system architects, app developers, UX, firmware/hardware counterparts, and quality/regulatory teams.
• Provide recurring delivery updates to senior leadership: status, milestones, risks, mitigations, and decisions.
• Lead/participate in continuous improvement (e.g., root-cause analysis, corrective actions, process optimization).
• When needed for SaMD, collaborate with clinical/usability teams during studies; ensure privacy safeguards and HIPAA compliance.

Education & Experience

Required:

• Bachelor's Degree in software, engineering, product, or related field.
• Minimum 6 years total professional experience in program or project management.
• Minimum 3 years specifically managing digital programs (web, mobile, marketing tech, digital transformation initiatives).
• Demonstrated success orchestrating cross-functional software delivery across multiple platforms, including regulated medical device environments.
• Experience managing resource plans, budgets, and vendor relationships.
• Experience with FDA Medical Devices and ideally preparing submissions for SaMD (in collaboration with Regulatory).
• Hands-on release coordination experience for non-regulated web apps and regulated software (e.g., SaMD) with complex cross-team dependencies.
• Familiarity with regulated environments and phase-gate processes.

Knowledge & Skills

• Working knowledge of QMS and regulatory frameworks relevant to software in healthcare (e.g., 21 CFR 820, ISO 13485); familiarity with 510(k) pathways for software components and SaMD.
• Proficiency with project planning tools (e.g., Azure DevOps, Monday.com, Smartsheet, ClickUp, etc.) and resource management practices.
• Comfortable operating within PDP/stage-gate processes; fluent in change control, traceability, verification/validation evidence, and release readiness checks.
• Excellent stakeholder communication; capable of translating technical and regulatory complexity into concise updates for executives and partners.
• Risk management, issue triage, and cross-team dependency management; data-driven status and decision making.
• Strong understanding of software development lifecycles across mobile, web, embedded, and eCommerce platforms.