Program Manager, Informatics R&D

Responsibilities

• Manage Informatics R&D projects involving software, systems engineering, data platforms, and cloud technologies
• Build and maintain project plans covering scope, milestones, schedules, dependencies, and risks
• Coordinate cross-functional deliverables across software engineering, regulatory, quality, and clinical teams
• Lead core team meetings and ensure actions, decisions, and risks are documented and driven to closure
• Support programs involving SaMD and SiMD products following design controls and regulatory plans
• Track scope, schedule, and tradeoffs within assigned programs
• Communicate project status, risks, and recommendations to leadership

Requirements

• Experience leading cross-functional teams through product development and release planning
• Experience managing schedules, milestones, and risks in a regulated environment
• Experience supporting software-intensive products (SaMD, SiMD, cloud-connected platforms, or AI/ML)
• Familiarity with medical device quality frameworks like ISO 13485, FDA design controls, or IEC 62304
• Proficiency with tools such as Jira, Confluence, Smartsheet, or Azure DevOps
• Bachelor’s degree in Engineering, Computer Science, Systems Engineering, or related field
• 5 years of relevant experience in project or program management

Preferred Qualifications

• PMP, Agile, Scrum, Lean, or Six Sigma certification
• Experience with medical device software or imaging systems