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 sites and time zones, aligning hardware work packages, build events, and test capacity between US and European locations.
• Coordinate supplier, contract manufacturer, and contractor deliverables and procurement tracking (SOW/PO/PCARD) in partnership with PM Operations, Supply Chain, and Finance; ensure supplier work aligns to schedule, quality, and deliverables.
• Execute assigned project(s) and provide data-driven recommendations and inputs.
• Lead project closure activities including lessons learned, final reporting, and transition to sustaining/lifecycle management, including post-launch field feedback and complaint-driven follow-up actions as applicable.
• Provide transparent project dashboards and stakeholder communications (status, KPIs, risks, decisions, and next milestones), and initiate/manage project escalations through closure when required.

Qualifications/Requirements:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, or related engineering field.
• 5+ years of project management experience within regulated Class II product development environments, with a dominant focus on electro-mechanical hardware (medical devices, surgical power tools, capital equipment, or comparable motor-driven, battery-powered, or embedded-firmware products).
• Demonstrated experience managing hardware development through prototype, EVT, DVT, and PVT build phases, design transfer, and manufacturing ramp.
• Experience with phase-gate execution and design controls documentation in a QMS environment, including design history file and traceability evidence for hardware.
• Experience coordinating suppliers, contract manufacturers, and external development partners on mechanical and electronic components, tooling, and assemblies.
• Demonstrated evidence of planning and supporting product launches in international markets, including familiarity with regional medical device regulatory requirements and market-entry expectations such as EU MDR, TGA, and other applicable international regulatory frameworks.
• Strong working knowledge of electro-mechanical product development, sufficient to engage credibly with mechanical, electrical, firmware, systems, and manufacturing engineers on design decisions, test results, and technical risk.
• Deep understanding of regulated medical device product development and phase-gate execution. Working knowledge of FDA 21 CFR Part 820 Quality Management System Regulation (QMSR), ISO 13485:2016, ISO 14971, and applicable design and development controls.
• Practical understanding of hardware development mechanics: requirements and specification flow-down, tolerance analysis, materials and finishing, design for manufacturability and assembly, tooling and molding lead times, and component qualification.
• Familiarity with the applicable hardware standards environment, including electrical safety and EMC (e.g., IEC 60601 series), battery and charging requirements, reliability and durability testing, cleaning and sterilization validation, and usability engineering (IEC 62366).
• Experience with FDA submissions and EU MDR technical documentation
• Demonstrated technical problem-solving leadership on hardware issues, including test failure investigation, root cause analysis, and corrective action planning.
• Working knowledge of hybrid execution models combining hardware work packages with Agile/Lean software and firmware delivery.
• Strong project controls and financial acumen including budget baselining, forecasting, earned value management (EVM) concepts, and data-driven performance reporting.
• Demonstrated ability to build and manage integrated schedules (IMS/WBS), critical path, and dependency mapping across cross-functional teams, including long-lead hardware and supplier dependencies.
• Proficiency with project management tooling (e.g., MS Project, Smartsheet, Planisware/Cadence PPM, Jira/Azure DevOps) and PLM/change management and documentation practices for hardware.
• Ability to read and work from engineering drawings, bills of materials, schematics, and test protocols and reports well enough to challenge assumptions and assess schedule impact
• Strong stakeholder management and communication skills; ability to produce clear dashboards, executive updates, and decision briefs.
• Ability to drive project resource and schedule planning across engineering disciplines and multiple sites, including US and European locations.
• Strong in RAID management and structured escalation; ability to drive mitigation actions and decisions to closure.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Required Skills:

Preferred Skills:
Computer Programming, Cost-Benefit Analysis (CBA), Critical Thinking, Data Science, Industrial Robotics, Industry Analysis, Innovation, Manufacturing Technologies, Problem Solving, Process Improvements, Prototyping, Relationship Building, Research and Development, Robotic Automation, Robotic Control Software, SAP Product Lifecycle Management, Technical Credibility, Technologically Savvy

The anticipated base pay range for this position is :
$109,000.00 - $174,800.00

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave - 80 hours in a 52-week rolling period10 days