Staff R&D Project Manager
PharmaMedTechClinical ResearchRegulatory AffairsQuality Assurancer programmingemafdaiso 13485mdrcro
Job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Product Development Job Sub Function: Robotics Job Category: Scientific/Technology All Job Posting Locations: Palm Beach Gardens, Florida, United States of America Job Description: About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for Staff R&D Project Manager to be based out of Palm Beach Gardens, FL. Purpose: The Staff Project Manager – Power Tools is responsible for planning and executing assigned projects within the Power Tools platform in Digital R&D, ensuring delivery against scope, schedule, cost, and quality in a regulated medical device environment. Power Tools are electro-mechanical orthopaedic solutions used by surgeons, combining mechanical mechanisms, motors and drivetrains, batteries and power electronics, embedded firmware, and cutting accessories into hand-held and capital surgical systems. Reporting to the Platform Program Manager – Power Tools, 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 mechanical engineering, electrical engineering, firmware, systems, V&V, quality, regulatory, supply chain, operations, and manufacturing partners, and drives disciplined design controls, prototype and build phase readiness, product development, Design Verification & Validation, Process Validation (PVE), design transfer, and phase-gate readiness to enable predictable delivery outcomes. Job Responsibilities: Own project planning and baseline management for assigned Power Tools projects, including project charter, scope baseline, WBS, and an integrated master schedule aligned to the platform program plan and to hardware build and tooling lead times. Manage project schedule execution, critical path tracking, milestone readiness, and schedule recovery actions; maintain and communicate weekly status to the platform leadership team. Plan and drive the electro-mechanical build and test cadence, including prototype, , product development, Design Verification & Validation, Process Validation (PVE) phases, ensuring builds, test units, tooling, fixtures, and sample quantities are scheduled and resourced ahead of need dates. Coordinate integration across mechanical design, electrical/PCB design, motor and drivetrain, battery and charging, and embedded firmware workstreams, ensuring interfaces, requirements, and design changes are managed to a single integrated plan. Own the project budget baseline, track actuals and forecasts, and perform earned value management (EVM) tracking, including capital, tooling, and prototype build spend; provide inputs for program-level financial reviews and funding decisions. Maintain the project RAID log (risks, issues, assumptions, dependencies) with proactive mitigation actions; escalate cross-project or platform-level risks and decisions through the Platform Program Manager. Lead weekly project core team meetings, drive action/decision tracking, and ensure timely follow-through across cross-functional contributors. Drive disciplined design controls and Design & Development Planning (DDP) execution, ensuring required evidence packages and reviews support regulatory and quality expectations. Partner with Quality Assurance and Regulatory Affairs throughout all phases of the project to integrate quality system and regulatory requirements into project plans, ensure compliance with applicable procedures and standards, and drive timely completion of required reviews, documentation, submissions, and approvals. Plan and track hardware verification and validation activities, including design verification testing, reliability and durability testing, EMC and electrical safety testing, environmental and transport testing, cleaning, sterilization, and biocompatibility evidence, and human factors/usability studies. Plan and coordinate design transfer and manufacturing readiness with Operations and Supply Chain, including bill of materials maturity, part numbers and master data, tooling and fixture readiness, process validation (IQ/OQ/PQ), first article inspection, packaging and labeling, and service and repair readiness. Manage engineering change execution for hardware, including engineering change orders, component obsolescence, second sourcing, and supplier-driven design changes, and assess downstream impact on verification evidence, traceability, manufacturing, and regulatory deliverables. Plan and coordinate product launch readiness for international markets, ensuring project plans account for regional regulatory, quality, commercial, supply chain, labeling, training, and market-entry dependencies. Plan and drive phase-gate readiness activities and toll-gate submissions (schedule, documentation, design and build readiness, V&V status, risk status, and stakeholder alignment). Manage project change requests (scope/schedule/cost) and ensure changes are reviewed, approved, and documented per governance and change control expectations. Drive project resource demand and capacity planning with functional leaders across mechanical, electrical, firmware, systems, V&V, and CAD/design services; surface and resolve resource conflicts and negotiate mitigation plans or escalations as needed. Coordinate execution across multiple engineering
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