Program Manager - Medical Device / Combination Products

Location: Hybrid - Onsite Tuesday, Wednesday & Thursday; Remote Monday & Friday in North Chicago, IL 60064

Duration: 12-Month Contract with Potential for Extension

Pay Rate: $92-$98/hour

About the Role

We are seeking an experienced Program Manager to lead complex, cross-functional programs supporting medical device and combination products throughout the product lifecycle. This role will provide project management leadership across new product introduction (NPI), commercialization, technical transfer, and ongoing support of marketed products. The Program Manager will partner closely with R&D, Engineering, Manufacturing, Quality, Regulatory, Supply Chain, Procurement, Commercial, and external suppliers to develop integrated project plans, manage risks and dependencies, and drive programs toward successful execution.

Responsibilities

• Lead complex, cross-functional programs supporting medical device and combination products from R&D handoff through development, commercialization, launch, and ongoing product support.
• Develop and maintain detailed project plans, schedules, critical paths, milestones, dependencies, and resource requirements using Microsoft Project.
• Coordinate global project teams across R&D, Engineering, Manufacturing, Quality, Regulatory, Supply Chain, Procurement, Commercial, and other functional areas.
• Manage new product introduction (NPI), product lifecycle/support initiatives, technical transfers, manufacturing activities, and global product launches.
• Facilitate cross-functional project meetings and design reviews, document decisions and action items, and ensure timely closure of outstanding activities.
• Identify project risks, constraints, and resource conflicts and develop appropriate mitigation and contingency plans.
• Monitor project timelines, budgets, deliverables, and milestones and communicate status, risks, decisions, and escalations to leadership.
• Partner with third-party manufacturers, suppliers, vendors, and contractors to ensure alignment with project requirements and shared milestones.
• Drive effective communication and collaboration among technical and business stakeholders across multiple functions and geographic locations.
• Resolve conflicts and negotiate priorities and resources while maintaining focus on overall program objectives.
• Support continuous improvement initiatives designed to improve efficiency, product quality, supply reliability, cost effectiveness, and project execution.
• Maintain appropriate project documentation and ensure programs are executed in accordance with applicable quality and regulatory requirements.
• Support teams operating across multiple time zones and participate in occasional domestic or international travel as needed.

Requirements

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 5+ years of experience within the medical device, pharmaceutical, or combination-product industry, with direct medical device and/or combination-product experience strongly preferred.
• Significant project or program management experience leading complex, cross-functional initiatives.
• Strong working knowledge of medical device design controls and design review processes.
• Advanced proficiency with Microsoft Project, including development and management of project schedules, dependencies, milestones, critical paths, and resource plans.
• Experience supporting product development, NPI, commercialization, technical transfer, manufacturing, and/or on-market product lifecycle initiatives.
• Demonstrated ability to lead cross-functional teams without direct reporting authority.
• Experience coordinating internal teams and external suppliers, manufacturers, or other third-party partners.
• Strong risk identification, mitigation, problem-solving, and critical-thinking capabilities.
• Excellent written and verbal communication skills with the ability to effectively communicate with technical teams, business stakeholders, and senior leadership.
• Strong conflict-resolution, negotiation, and stakeholder-management skills.
• Ability to work effectively within a global, matrixed organization.

Preferred Qualifications

• 10+ years of diversified experience across project/program management, medical devices, combination products, pharmaceutical operations, manufacturing, quality, supply chain, or related functions.
• PMP or other PMI certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with global product launches and international manufacturing or supplier operations.
• Experience supporting product maintenance and improvements for commercially marketed products.
• Knowledge of manufacturing validation, supplier quality, risk management, and commercial product launches.
• Experience working with geographically dispersed teams and international suppliers.

Ideal Candidate

The successful candidate will be a highly collaborative and results-oriented project leader who can navigate complex technical programs, build consensus across diverse teams, and drive decisions with limited supervision. This individual should be comfortable balancing multiple priorities, challenging assumptions, resolving conflicts, and communicating clearly with stakeholders at all levels of the organization.

Candidates should demonstrate a strong sense of urgency, sound judgment, strategic and critical thinking, and the ability to keep complex programs moving forward in a highly regulated environment.