Senior Program Manager, Informatics R&D

Responsibilities

• Lead complex cross-functional Informatics R&D programs involving software, systems engineering, data platforms, and cloud technologies
• Build and maintain integrated program plans covering scope, milestones, schedules, dependencies, and risks
• Drive program execution through regular operating cadence, status reporting, and risk management
• Coordinate deliverables across software engineering, regulatory, quality, clinical, and operations groups
• Manage programs involving SaMD and SiMD products ensuring alignment with design controls and regulatory strategy
• Partner with Systems Engineering, Regulatory Affairs, and Quality to coordinate development and validation
• Communicate program status, risks, and recommendations to executive stakeholders

Requirements

• Bachelor’s degree in Engineering, Computer Science, Systems Engineering, Biomedical Engineering, Life Sciences, or Business
• Minimum 8 years of experience in project/program management or product development
• Experience leading cross-functional teams through product development and release planning
• Experience in a regulated product development environment (e.g., medical device)
• Experience with software-intensive products (SaMD, SiMD, cloud-connected platforms, or AI/ML)
• Familiarity with medical device quality standards like ISO 13485, FDA design controls, or IEC 62304
• Proficiency with tools such as Jira, Confluence, Smartsheet, or Azure DevOps
• Strong analytical, organizational, and communication skills

Preferred Qualifications

• Advanced degree in a related technical or business field
• PMP, PgMP, Agile, Scrum, Lean, or Six Sigma certification
• Experience with internationally deployed teams