Program Manager, Informatics R&D

We are seeking an experienced Program Manager to support execution of cross-functional Informatics R&D programs involving software-intensive medical products, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) deployed on electro-mechanical systems or cloud platforms.

This role is responsible for driving disciplined execution within defined program or project scope, ensuring that work is planned, tracked, and delivered with clarity and accountability in a regulated medical device environment. The Program Manager coordinates cross-functional teams, maintains visibility into execution status, and ensures that deliverables, risks, decisions, and action items are actively managed.

To be successful the ideal candidate would be organized, collaborative, detail-oriented, and able to keep cross-functional teams aligned on priorities, commitments, execution risks, and next steps.

Role Scope

The Program Manager owns execution tracking and coordination for defined projects or programs with established objectives, timelines, and constraints. This role is accountable for maintaining execution discipline, creating transparency, and ensuring that assigned work progresses with clarity, ownership, and appropriate escalation.

This includes:

Maintaining project or program plans, schedules, milestones, dependencies, risks, decisions, and action items.

Coordinating cross-functional deliverables across technical, regulatory, quality, clinical, product, and operational stakeholders.

Ensuring meetings, plans, decisions, and follow-up actions are documented and driven to closure.

Identifying and solving execution gaps, open decisions, risks, and unresolved dependencies.

Escalating issues in a timely and constructive manner to support on-time, on-scope execution.

Essential Duties and Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

Manage defined Informatics R&D projects or programs involving software, systems engineering, data platforms, cloud technologies, medical device software, and related informatics capabilities.

Build and maintain project or program plans covering scope, milestones, schedules, dependencies, deliverables, risks, decisions, and action items.

Coordinate program execution through regular status reporting, meeting cadence, action tracking, decision tracking, risk tracking, and issue escalation.

Coordinate cross-functional deliverables across software engineering, systems engineering, data and informatics, product management, regulatory, quality, verification and validation, clinical, operations, and other stakeholder groups.

Lead core team meetings and planning discussions, ensuring actions, owners, decisions, risks, and open issues are documented and followed through to closure.

Support programs involving SaMD and SiMD products deployed on electro-mechanical systems or cloud platforms, ensuring execution follows applicable design controls, quality system expectations, regulatory plans, and controlled documentation processes.

Partner with Systems Engineering, Regulatory Affairs, and Quality to coordinate development, verification, validation, risk management, and regulatory deliverables.

Track scope, schedule, risks, dependencies, and tradeoffs within assigned projects or programs.

Support roadmap, release, and portfolio planning activities by providing accurate project status, schedule, risk, and dependency information.

Use modern project planning, development support, and collaboration tools to create visibility, manage execution, track dependencies, and support decision-making.

Communicate project or program status, risks, issues, and recommendations clearly to core teams, functional managers, and program leadership.