Software Project Manager

We are seeking an experienced Software Project Manager to lead medical device product development projects in a regulated environment. The candidate will manage project schedules, budgets, risks, and cross-functional teams to ensure timely delivery while meeting quality and regulatory requirements., * 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.

Project/Program Management, Project/Program Management, Time Management, Product Development, Cross-Functional, Project Schedule, Medical Equipment, Regulatory Requirements, Budgeting, Schedule Development, * 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.

Preferred: Experience with Class II/III medical devices, robotics, navigation systems, or software-enabled products.

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: 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.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws