Software Project Manager

Novozen Healthcare LLC is seeking a Software Project Manager to lead medical device product development projects in a regulated environment. The role manages schedules, budgets, risks, and cross-functional teams while supporting quality and regulatory requirements.

Responsibilities:

• Develop and manage project plans, schedules, budgets, and milestones
• Track project progress, costs, resources, and deliverables
• Identify and manage project risks, issues, dependencies, and change requests
• Coordinate software, systems, engineering, quality, regulatory, and manufacturing teams
• Lead project meetings and communicate status updates to stakeholders
• Support medical device design controls, documentation, and phase-gate reviews
• Coordinate Agile sprints and cross-functional project activities
• Manage vendor deliverables, resource planning, and project reporting
• Prepare project dashboards and drive issues through resolution
• Support project closure, lessons learned, and transition activities

Requirements:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field
• 5+ years of project management experience in regulated medical device or product development environments
• Experience managing projects involving software, systems, and hardware
• Knowledge of medical device design controls, phase-gate processes, and quality management systems
• Familiarity with FDA 21 CFR 820.30 and ISO 13485
• Experience with Agile, SAFe, Lean, or hybrid project management methodologies
• Experience with project schedules, budgets, forecasting, risk management, and earned value management (EVM)
• Proficiency with MS Project, Smartsheet, Planisware, Jira, or Azure DevOps
• Strong communication, leadership, organization, and stakeholder management skills
• Experience with Class II/III medical devices, robotics, navigation systems, or software-enabled products