Project Manager

Project Manager – Medical Device / Combination Products About the Role We are seeking an experienced Project Manager to lead cross-functional programs supporting New Product Introduction (NPI), commercialization, technical transfers, product maintenance, and global launches within a medical device/pharmaceutical environment. This role will work closely with R&D, Engineering, Manufacturing, Quality, Regulatory, Supply Chain, Commercial, and external suppliers to deliver projects on time, within budget, and in compliance with applicable requirements. Key Responsibilities Lead end-to-end NPI, commercialization, technical transfer, and product support programs. Develop and manage integrated project plans, timelines, milestones, budgets, risks, and resources. Lead cross-functional and global teams across R&D, Engineering, Manufacturing, Quality, Regulatory, Supply Chain, and Commercial. Manage project execution using Microsoft Project and other PM tools . Identify risks, resolve conflicts, drive corrective actions, and escalate issues appropriately. Coordinate third-party suppliers, vendors, contractors, and global stakeholders. Support process improvement and Lean initiatives to improve quality, efficiency, cost, and delivery. Provide regular project/program status updates to senior leadership. Drive alignment and accountability across multiple functions and time zones. Ensure projects meet quality, regulatory, business, and commercialization objectives. Required Qualifications Bachelor’s degree in Engineering, Science, or related discipline . 10+ years of program/project management or diversified business experience . 5+ years of experience in medical devices, pharmaceuticals, or combination products. Strong experience with NPI, commercialization, technical transfer, product launches, or product support . Working knowledge of medical device design controls and R&D practices . Proven experience leading cross-functional/global teams . Strong proficiency with Microsoft Project and Microsoft Office . Excellent communication, stakeholder management, conflict resolution, and leadership skills. Preferred Qualifications PMP/PMI certification. Lean Six Sigma Green Belt or Black Belt. Advanced business degree/MBA. Experience with global product launches and third-party supplier management. Experience with capital/expense management and manufacturing/operations support. Ideal Candidate The ideal candidate is a strategic, results-oriented leader who can manage complex global programs, influence cross-functional teams, resolve issues quickly, and drive projects from R&D handoff through launch and commercialization with minimal supervision. #J-18808-Ljbffr K3-Innovations, Inc.