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Project Manager – Software as a Medical Device (SaMD)
Job Location:
Job Location:
Boston, MA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
30 July 2026 (30+ days ago)
Posted:
Application Deadline:
27 October 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title: Project Manager - Software as a Medical Device (SaMD)
Location: Boston MA
Experience: 4-6 Years
Job Summary
We are seeking an experienced Project Manager to lead the production implementation of a Software as a Medical Device (SaMD) solution under the TruMatch Program. The ideal candidate will have end-to-end project management experience strong Agile expertise and experience managing regulated medical device software projects within DePuy Synthes or Johnson & Johnson (J&J) environments. Knowledge of GxP-compliant software development and the Software Development Life Cycle (SDLC) is highly preferred.
Required Skills
Project Management
- End-to-End Project Management
- Project Planning & Execution
- Project Charter
- Production Deployment
- Project Scheduling
- Resource Management
- Risk & Issue Management
- Budget & Timeline Management
- Change Management
- Stakeholder Management
Medical Device & Regulatory
- Software as a Medical Device (SaMD)
- Medical Device Regulations
- FDA Guidelines
- GxP Compliance
- SDLC (Software Development Life Cycle)
- Medical Device Quality Systems
- Validation & Verification
- Regulatory Compliance
Agile Delivery
- Agile Methodology
- Scrum
- Sprint Planning
- Backlog Management
- Jira
- Agile Project Delivery
Collaboration
- Cross-functional Team Leadership
- Vendor Management
- External Partner Coordination
- Executive Communication
- Stakeholder Communication
Tools
- Jira
- Microsoft Project
- Confluence
- Microsoft Office Suite
Soft Skills
- Leadership
- Problem Solving
- Decision Making
- Communication
- Organization
- Analytical Thinking
- Team Collaboration
Key Responsibilities
- Lead the end-to-end implementation of a Software as a Medical Device (SaMD) solution from project initiation through production launch.
- Develop and manage project plans schedules milestones risks and deliverables.
- Collaborate with internal development teams external software development partners and cross-functional stakeholders.
- Ensure project execution aligns with GxP-compliant software development processes and SDLC best practices.
- Facilitate Agile ceremonies including sprint planning reviews retrospectives and backlog refinement.
- Monitor project progress resolve issues and proactively manage risks and dependencies.
- Coordinate production deployment validation activities and go-live readiness.
- Maintain project documentation status reports and executive communications.
- Utilize Jira and project management tools to track project execution and delivery.
- Ensure timely delivery while maintaining quality compliance and business objectives.
Preferred Qualifications
- Experience managing projects within DePuy Synthes or Johnson & Johnson (J&J) environments.
- Experience delivering Software as a Medical Device (SaMD) products.
- Knowledge of FDA medical device regulations GxP and regulated SDLC processes.
- PMP PMI-ACP Scrum Master (CSM) or equivalent project management certification.
- Bachelors degree in Engineering Computer Science Life Sciences or a related field.
