Project Manager

About the Company

NAMSA pioneered the medical device testing industry and was the first independent company in the world to focus solely on medical device materials for safety. Founded before the U.S. Food and Drug Administration began regulating such products in 1976, NAMSA has shaped the industry by developing the test methods that govern it. Today, NAMSA is the premier provider of support for clients throughout every step of the product development lifecycle and beyond.

The organization is guided by the vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success. NAMSA’s mission is to deliver best-in-class global MedTech development solutions through its people, expertise, and technology, adhering to core values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives, and ideas.

Responsibilities

• Partner with clients, cross-functional teams, and sub-contractors to effectively staff and manage project execution throughout the entire project lifecycle.
• Serve as the key liaison with clients, including communications in critical and high-profile discussions.
• Resolve or de-escalate challenging situations with clients and escalate issues to management when necessary.
• Balance both client and NAMSA business needs.
• Facilitate up-front client engagement to establish project scope, deliverables, timelines, communication requirements, invoicing, and ensure client expectations are met for quality, schedule, and budget.
• Facilitate project handoff from commercial to operations with a signed Statement of Work (SOW).
• Ensure accurate and timely project setup and team access in applicable systems, including SharePoint, AX, and project-specific systems.
• Lead project planning, including deliverables, schedule, budget, resources, communications, meetings, scope metrics, workplan, roles and responsibilities, and risk management.
• Manage financial aspects of projects according to the SOW and facilitate change orders as needed.
• Lead project closure with client acceptance, surveys, documentation, and system closure.
• Gather and act on lessons learned as applicable.
• Provide timely feedback on team members using appropriate performance management processes.
• Utilize NAMSA project management best practices and tools, and drive improvements in capability, utilization, and cycle time.
• Support simple single-service projects with minimal cross-functional interaction or assist senior project managers with complex projects.
• Work under general supervision, following established procedures with some latitude in decision-making.
• Ensure projects are executed following Quality System (QS) requirements and applicable procedures.
• Maintain project metrics and reporting for management reviews.
• Support client and regulatory audits and follow-up.
• File complaints and support Corrective and Preventive Actions (CAPAs) or quality initiatives for process improvement.
• Participate in prospective and current client meetings and identify opportunities to offer additional services.
• Provide project schedule, resource, and budget information to support proposal creation.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in a related field required; equivalent experience may be considered.
• MBA or advanced degree preferred.
• Minimum of 3 years of experience in medical device, clinical, regulatory, or a related field.
• At least 1 year of project management experience.
• Demonstrated execution of project management tools, processes, practices, and procedures.
• Advanced certification in a relevant program (e.g., project management, clinical research, Six Sigma, Lean) preferred.
• Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Procedures (GMP) preferred.
• Proficient with MS Project or similar tools and SharePoint.
• Ability to navigate complexity, competing priorities, and limited resources.
• Strong verbal and written communication skills, with the ability to motivate, influence, and negotiate.
• Excellent time management, organization, and project management skills.
• Effective analytical and problem-solving capabilities, with the ability to simplify complex problems.
• Understanding of project financials and their impact on the business.
• Understanding of technical project components and their impact on other areas.
• Ability to work in a highly matrixed team environment.
• Ability to train and mentor others.

Working Conditions

• Regularly required to talk or hear.
• Frequently required to stand, walk, sit, use hands to handle or feel, and reach with hands and arms.
• Occasionally required to lift and/or move up to 25 pounds (12 kg).
• Extensive use of a computer keyboard.
• Travel approximately 20% of the time.

Pay

Compensation target: $85,000.00 annually. The compensation grade range for this position is $68,800.00 – $133,700.00 per year. Individual base pay depends on factors such as role complexity, job duties, relevant experience and skills, and primary work location.