SW Project Manager - Medical Devices - Remote
Job Description
Title: SW Project Manager
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Location: Remote (Periodic onsite visits required in Massachusetts)
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Duration: 6–12 months plus
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Overview
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Section 1: Location and Travel Requirements
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• Primary location: Boston, MA, USA.
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• Hybrid work model with a minimum of three days per week onsite or Remote with visits
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• Estimated travel of up to 30%, domestic and international.
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Client is seeking a Software Project Manager to lead execution across a medical device program with a strong emphasis on software development, risk mitigation, and cross-functional alignment.
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Project Manager – Product Platform
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The Project Manager – Product Platform is responsible for planning and executing assigned projects within a product platform in a digital research and development environment, ensuring delivery against scope, schedule, cost, and quality requirements in a regulated medical device setting. Reporting to the Platform Program Manager, this role owns the project-level integrated plan (WBS/IMS), project budget baseline and EVM tracking, project RAID management, change control, and stakeholder communications. The Project Manager coordinates cross-functional execution across software, systems, verification and validation, clinical, quality, regulatory, and manufacturing partners, and drives disciplined design controls and phase-gate readiness to enable predictable delivery outcomes.
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Section 2: Duties & Responsibilities
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In accordance with all applicable federal, state, and local laws and regulations, as well as corporate policies, procedures, and guidelines, this position:
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• Owns project planning and baseline management for assigned projects, including the project charter, scope baseline, WBS, and integrated master schedule aligned to the platform program plan.
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• Manages schedule execution, critical path tracking, milestone readiness, and schedule recovery actions; maintains and communicates weekly status to platform leadership.
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• Owns the project budget baseline, tracks actuals and forecasts, and performs earned value management (EVM) tracking; provides inputs for program-level financial reviews and funding decisions.
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• Maintains the project RAID log covering risks, issues, assumptions, and dependencies, with proactive mitigation actions; escalates cross-project or platform-level risks and decisions through the Platform Program Manager.
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• Leads weekly project core team meetings, drives action and decision tracking, and ensures timely follow-through across cross-functional contributors.
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• Drives disciplined design controls and Design and Development Planning (DDP) execution, ensuring required evidence packages and reviews support regulatory and quality expectations.
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• Plans and drives phase-gate readiness activities and toll-gate submissions, including schedule, documentation, verification and validation readiness, risk status, and stakeholder alignment.
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• Manages project change requests related to scope, schedule, and cost, ensuring changes are reviewed, approved, and documented in accordance with governance and change-control expectations.
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• Drives project resource demand and capacity planning with functional leaders; surfaces and resolves resource conflicts and negotiates mitigation plans or escalations as needed.
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• Supports hybrid execution cadences, including Agile sprints and hardware work packages, by coordinating sprint-planning inputs, backlog readiness, and integration dependencies with the Scrum Master, Software Lead, and technical leads.
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• Coordinates vendor and contractor deliverables and procurement tracking, including SOWs, purchase orders, and purchasing-card activity, in partnership with project operations and Finance; ensures supplier work aligns with schedule, quality, and deliverable expectations.
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• Executes assigned projects and provides data-driven recommendations and inputs.
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• Leads project closure activities, including lessons learned, final reporting, and transition to sustaining or operations teams, as applicable.
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• Provides transparent project dashboards and stakeholder communications covering status, KPIs, risks, decisions, and next milestones; initiates and manages project escalations through closure when required.
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Section 3: Experience and Education
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• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
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• Five or more years of project management experience within regulated Class II medical device or product development environments; experience with medical devices, robotics, navigation, or software-enabled products is preferred.
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• Experience with phase-gate execution and design-control documentation in a quality management system (QMS) environment.
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• Experience with Class II or Class III medical devices, robotics, navigation, or software-enabled products is preferred.
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Section 4: Required Knowledge, Skills, Abilities, Certifications, Licenses, and Affiliations
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• Deep understanding of regulated medical device product development and phase-gate execution, including FDA 21 CFR 820.30 and ISO 13485 design controls.
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• Experience managing complex, cross-functional programs across software, systems, and hardware, including integrated planning across requirements, architecture, verification and validation, clinical, quality, and regulatory deliverables.
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• Demonstrated technical problem-solving leadership.
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• Excellent knowledge of Agile, Lean, SAFe, or hybrid execution models.
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• Strong project controls and financial acumen, including budget baselining, forecasting, earned value management (EVM) concepts, and data-driven performance reporting.
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• Demonstrated ability to build and manage integrated schedules (IMS/WBS), critical paths, and dependency maps across cross-functional teams.
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• Proficiency with project management tools such as MS Project, Smartsheet, Planisware, PPM platforms, Jira, or Azure DevOps, as well as related documentation practices.
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• Strong stakeholder management and communication skills, with the ability to produce clear dashboards, executive updates, and decision briefs.
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• Experience operating in Agile, SAFe, or hybrid delivery models, with the ability to drive project resource and schedule planning.
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• Strong RAID management and structured escalation skills, with the ability to drive mitigation actions and decisions to closure.
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• Strong project-control capabilities, including budget baselining, forecasting, and earned value management (EVM) concepts.