Staff R&D Project Manager – Orthopedic Power Tools

Johnson and Johnson

Town of Florida (NY)

On-site

USD 109,000 - 175,000

Full time

9 days ago

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Benefits offered by this job

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Parental Leave

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Job summary

Johnson & Johnson is seeking a Staff R&D Project Manager for the Power Tools platform in Palm Beach Gardens, FL. You will lead cross-functional teams across mechanical, electrical, firmware, and manufacturing to ensure on-time, on-budget delivery in a regulated medical device environment.

Role requires 5+ years of PM experience, expertise in phase-gate execution, risk management, and strong regulatory knowledge (FDA/ISO).

Qualifications

Bachelor's degree in a engineering field and 5+ years PM in regulated Class II medical device development.
Experience with hardware development through EVT/DVT/PVT, design transfer and manufacturing ramp.
Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971 and design controls.
Proven ability to manage suppliers, contract manufacturers and external partners.

Responsibilities

Own project planning baseline, WBS, and integrated master schedule for Power Tools.
Lead schedule execution, critical path tracking, and weekly status to leadership.
Plan electro-mechanical build/test cadence across EVT/DVT/PVT and verification activities.
Coordinate interfaces across mechanical, electrical, firmware, and manufacturing workstreams.
Own budget baseline, track actuals/forecasts, and perform EVM for capital and tooling spend.
Maintain RAID log with proactive mitigation and escalate as needed.
Lead weekly core-team meetings and drive actions to timely closure.
Ensure regulatory and quality evidence via design controls and V&V planning.
Collaborate with QA/RA to integrate regulatory requirements into plans.
Plan hardware verification, reliability, EMC, environmental and usability testing.
Coordinate design transfer and manufacturing readiness; BOM maturity and lead time planning.
Manage engineering changes and supplier-driven design changes with impact assessment.
Plan product launch readiness for international markets including regulatory impacts.
Drive phase-gate readiness, toll-gate submissions, and governance approvals.
Manage resource demand/capacity with functional leaders across sites.
Coordinate multi-site execution (US/Europe) and supplier deliverables.
Execute assigned projects and provide data-driven recommendations.
Close projects with lessons learned and transition to sustaining lifecycle.