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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Project Manager - Software as a Medical Device (SaMD) - **Company:** Purple Drive Technologies LLC - **Location:** Boston, MA, United States - **Experience:** Expert - **Salary:** $115,000.0 - $182,000.0 - **Contract:** Permanent contract - **Skills:** Agile Methodology, Confluence, JIRA, Microsoft Office, Microsoft Project, Scrum Methodology, Systems Development Life Cycle, Software Deployment, Software Engineering, Information Technology, GXP - **Published:** August 1, 2026 - **Apply:** https://www.careerjet.com/jobad/usac3d902671d6b6adff03748ee8ed230c ## About the Role * 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. ## Description 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 + Apply easily + ## Related Videos - [Improving quality with Agentic AI with Rovo Dev and Xray](https://www.wearedevelopers.com/videos/2005-improving-quality-with-agentic-ai-with-rovo-dev-and-xray) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [42 x 2 Canvases Later: Two Years, Two Minds, Many Lessons](https://www.wearedevelopers.com/videos/1458-42-x-2-canvases-later-two-years-two-minds-many-lessons) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [A Founder's Journey : From Startup Chaos to Purposeful Growth](https://www.wearedevelopers.com/videos/1926-a-founder-s-journey-from-startup-chaos-to-purposeful-growth) - [Collaboration Quantified: Lessons from Open Source Developer Networks](https://www.wearedevelopers.com/videos/1422-collaboration-quantified-lessons-from-open-source-developer-networks) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Events like RSAC Get You CISOs. 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