Project Manager

About the company:

Headquartered in Itasca, Illinois, with a satellite location in Belgium, Organ Recovery Systems is a global market-leading provider of organ preservation products and services. We support over 400 transplant programs across 49 countries. In 2025, the company reached 275,000 kidneys perfused with LKT since its launch in 2003. LifePort Kidney Transporter is among a growing family of products and services developed by Organ Recovery Systems to support the Company’s mission of honoring organ donation by delivering innovative solutions that support transplant professionals and improve long-term outcomes for patients.

POSITION SUMMARY:

The Project Manager will lead complex cross-functional initiatives within an FDA-regulated medical device, pharmaceutical, biotechnology, or diagnostics environment. Candidates must have at least 5 years of project and/or program management experience supporting regulated product development, manufacturing, quality, validation, regulatory, or commercialization activities. The ideal candidate has hands-on experience navigating Design Controls, Quality Systems, GMP requirements, Validation processes, and other regulatory requirements that govern product development and commercialization.

This role is responsible for driving project execution from concept through launch, coordinating cross-functional teams, managing project plans, schedules, budgets, risks, and deliverables, and ensuring alignment with business objectives and regulatory expectations. Strong proficiency with project management tools is required, with Smartsheet experience highly preferred. Candidates who have leveraged Smartsheet to build project plans, manage timelines, monitor dependencies, and provide project visibility across stakeholders will be particularly well-suited for this role.

This position requires exceptional communication, organizational, and stakeholder management skills, with the ability to influence cross-functional teams and drive results in a fast-paced, highly regulated environment.

PRIMARY (Essential) FUNCTIONS:

• This role will be responsible for managing assigned company projects, including scheduling and facilitating project team meetings, aligning stakeholders, assigning and tracking action items, monitoring project progress, and driving the team to deliver projects on time, within scope, and within approved budget parameters.
• This role will be responsible for organizing project communication, maintaining project documentation, and coordinating cross-functional project activities to ensure smooth and efficient project execution.
• Create, develop, maintain, and execute plans for organizational projects, including setting targets for milestones and adhering to deadlines while managing projects through the project lifecycle as follows:

Project Kickoff/Planning

• Complete and maintain a Project Plan, including task definition, task sequencing, resource allocation, timeline estimates, potential risks and mitigation plans, dependencies, communication plan, and success criteria for the project.
• Coordinate with project sponsors, department leaders, and functional stakeholders to confirm project scope, objectives, roles, responsibilities, and resource needs.
• Procure and manage adequate project resources to achieve project objectives in planned timeframes, escalating resource constraints when necessary.

Project Execution

• Work closely with stakeholders within and outside of the organization to ensure assigned projects are delivered on time and within scope.
• Organize and run project meetings with the appropriate team members to ensure proper understanding of the project initiatives, milestones, timelines, deliverables, risks, decisions, and corresponding responsible parties.
• Assign tasks and responsibilities to appropriate personnel and follow up to ensure timely completion.
• Effectively communicate with superiors, team members, clients, vendors, consultants, and other stakeholders.
• Motivate project team members to meet project goals and maintain accountability for assigned deliverables.
• Manage project scope, schedule, budget, risks, issues, assumptions, dependencies, and change requests.
• Participate in establishing and improving practices, templates, policies, tools, and partnerships that facilitate project success.
• Participate in quality issue resolution and ensure project activities support applicable quality, regulatory, and documentation expectations.
• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence.
• Organize project deliverables and supporting documentation, including meeting minutes, action items, decisions, status reports, and related project artifacts, on the appropriate project share drive (Ex. SharePoint, OneDrive, etc.).
• Manage the day-to-day project activities and resource coordination for assigned projects.Provide regular status reporting to the Manager, Program Management Office and project sponsors regarding project milestones, deliverables, dependencies, risks, issues, decisions, and budget-related updates.
• Identify and escalate potential project roadblocks or hurdles that may impact project timeline, scope, quality, or budget in a timely manner.

Project Closing

• Verify all project objectives have been achieved, deliverables have been completed, final documentation has been organized, and project performance has been evaluated.
• Report on project success criteria results and metrics.
• Review Lessons Learned from the project and share with the Manager, Program Management Office to evaluate the need for future process improvements.
• Organize and facilitate smooth and efficient forward progress of daily operations projects, as needed.
• Help department heads organize and run ongoing project meetings, as needed.
• Provide support needed by department heads to ensure ongoing smooth progress of assigned projects.
• Assign action items and track status/completion to ensure continued forward progress of ongoing projects.
• Assist, as needed, with purchase order requests and related follow-up.
• Serve as primary point of contact, as needed, for contract manufacturers, third party labs, consultants, and vendors associated with assigned projects.

OTHER FUNCTIONS:

• Assist the PMO Office, as needed, with implementation of process initiatives and improvements to increase efficiency and productivity across the organization.
• Contribute to PMO standards, reporting discipline, templates, and project management best practices.
• Continue professional development to keep abreast of emerging technologies, methods, and best practices.

Qualifications:

Bachelor’s degree in Science, Engineering, Business, Project Management, or a related technical or medical field, or an equivalent combination of education and experience

5+ years of project and/or program management experience within medical device, pharmaceutical, biotechnology/biologics, diagnostics, or other FDA-regulated life sciences industries. Candidates should have with exposure to regulated processes such as Regulatory Compliance, GMP, Quality Systems, Design Controls, Product Development, Manufacturing, Validation, or Commercialization.

5-7 years of professional experience in project management, program coordination, or related roles
Experience leading projects or workstreams requiring strong communication, organization, stakeholder engagement, and accountability for results
Experience supporting cross-functional teams, project schedules, risk management, action item tracking, and project documentation preferred

Ability to manage projects from initiation through completion while balancing scope, schedule, budget, and quality objectives
Strong leadership skills with the ability to coordinate and motivate cross-functional teams and external partners
Clear and confident communication skills that keep teams aligned and stakeholders informed
Exceptional organizational skills with strong attention to detail and the ability to manage multiple priorities in a fast-paced environment
Ability to build relationships, influence outcomes, and gain buy-in from stakeholders at all levels
Experience supporting project financial processes, including purchase orders, vendor coordination, and invoice tracking
Proficiency with project management and collaboration tools such as Microsoft Project, Smartsheet, SharePoint, and Microsoft Excel
Strong interpersonal skills with the ability to facilitate collaboration, drive progress, and support organizational change;
Composed, adaptable, and solutions-oriented approach when working under pressure

Why Join Us?

At Organ Recovery Systems, we invest in our people by providing competitive benefits that support your health, financial well-being, career growth, and life outside of work.

Annual Incentive Bonus Opportunity
Comprehensive Medical, Dental & Vision Coverage
Company-Paid Life Insurance, Short-Term & Long-Term Disability Coverage
Flexible Spending Accounts (Health & Dependent Care FSA)
401(k) with 100% Company Match on the First 5% of Contributions
Generous Paid Time Off, Including Vacation, Sick, Personal, Volunteer Time & Paid Holidays
Paid Parental Leave
Summer Hours Program
Tuition Reimbursement & Professional Development Support
Employee Assistance Program (EAP) & Identity Theft Protection
Pet Insurance & Legal Plan Options
Technology & Wellness Reimbursement
STEM Scholarship Program for Eligible Dependents
A Culture Focused on Employee Well-Being, Growth, and Work-Life Balance