Job Title: Software Project Manager
Location: Remote (Periodic onsite visits in Massachusetts required)
Employment Type: Contract (W2)
Job Summary
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.
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.
Preferred: Experience with Class II/III medical devices, robotics, navigation systems, or software-enabled products.
Pay Scale
Anticipated hourly pay range: $55/hr to $65/hr.
Benefits
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