Project Manager - Software as a Medical Device (SaMD)

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, * 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., The Senior Operations Manager is responsible for leading day-to-day manufacturing operations across internal production, contract manufacturing partners, production test, and facil…
• 8 days ago
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• 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, * 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.
• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.