Note: The job is a remote job and is open to candidates in USA. 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
Skills
- 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
Benefits
- Medical, dental, and vision insurance options are available through a third-party provider; employees are responsible for paying the full cost of their insurance premiums.
- A 401(k) retirement savings plan is available; no employer matching or other employer contributions are provided.
- Remote work, with periodic onsite visits in Massachusetts required.
Company Overview
Company H1B Sponsorship