Project Manager

K3-Innovations, Inc.; Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

K3-Innovations, Inc. in Chicago, IL, seeks an experienced Project Manager to lead cross-functional programs across NPI, commercialization, technical transfers, product maintenance, and global launches in a medical device/pharmaceutical setting.

This role collaborates with R&D, Engineering, Manufacturing, Quality, Regulatory, Supply Chain, Commercial, and external suppliers to deliver projects on time, within budget, and compliant with requirements.

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.
• 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.

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.
• Coordinate third-party suppliers, vendors, contractors, and global stakeholders.
• 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.

Skills

Cross-functional teams

NPI & launches

Project management

Stakeholder management

Leadership

Communication

Education

Engineering degree

Tools

Microsoft Project

Microsoft Office

Job description

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.