Project Manager

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our 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.

Job Description:

• Work with the client , cross-functional team and sub-contractors to effectively staff and manage project execution throughout the entire project life cycle
• Serve as key liaison with client, including communications in critical and high-profile discussions
• Handle challenging situations with the client, and knows when to escalate issues to management
• Ensure a balance of both the client and NAMSA business needs
• Facilitate up-front client engagement to establish project scope, deliverables, timeline, client requirements for communication, invoicing etc. and ensures client expectations are met for quality, schedule and budget
• Facilitate project handoff from commercial to operations with signed SOW
• Facilitate accurate and timely project set-up and team access in applicable systems, including SharePoint, AX, and project specific systems.
• Organize and facilitate appropriate meetings and provide ongoing project information
• Lead project planning of deliverables, schedule, budget, resources, communications and risk management.
• Work with the team to outline work plans and assign roles and responsibilities.
• Manage financial aspects of the projects according to the statement of work and facilitate change orders as needed.
• Lead project closure with client acceptance and survey, documentation and system closure
• Gather and take action on lessons learned. Provide timely feedback on team members using the 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 supports senior project managers with complex projects.
• Work under general supervision and follows established procedures with some latitude in decision making and approach to responsibilities.
• Ensure projects are executed following QS requirements and applicable procedures
• Maintain project metrics and reporting for management reviews.
• Support client and regulatory audits and follow-up
• Ensure any complaints are filed
• Support CAPAs as needed for quality and process improvements.
• Participate in prospective client meetings
• Provide project schedule, resource, and budget information as needed to support creation of proposals.
• Identifie opportunities to offer additional services to clients during project engagements.

Qualifications & Technical Competencies:

Principal Duties and Responsibilities

• Work with the client , cross-functional team and sub-contractors to effectively staff and manage project execution throughout the entire project life cycle
• Serve as key liaison with client, including communications in critical and high-profile discussions
• Handle challenging situations with the client, and knows when to escalate issues to management
• Ensure a balance of both the client and NAMSA business needs
• Facilitate up-front client engagement to establish project scope, deliverables, timeline, client requirements for communication, invoicing etc. and ensures client expectations are met for quality, schedule and budget
• Facilitate project handoff from commercial to operations with signed SOW
• Facilitate accurate and timely project set-up and team access in applicable systems, including SharePoint, AX, and project specific systems.
• Organize and facilitate appropriate meetings and provide ongoing project information
• Lead project planning of deliverables, schedule, budget, resources, communications and risk management.
• Work with the team to outline work plans and assign roles and responsibilities.
• Manage financial aspects of the projects according to the statement of work and facilitate change orders as needed.
• Lead project closure with client acceptance and survey, documentation and system closure
• Gather and take action on lessons learned. Provide timely feedback on team members using the 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 supports senior project managers with complex projects. 
• Work under general supervision and follows established procedures with some latitude in decision making and approach to responsibilities.

Senior Project Manager

In addition to the responsibilities listed above:

• Support complex single service projects with significant cross-functional interaction and multi-service projects and MRO programs
• Within QS framework, works under minimal supervision and has significant latitude in decision making and approach to responsibilities

Principal Project Manager

In addition to the responsibilities listed above:  

• Support clients with multi-service and bundled projects, and/or significant MRO Programs
• Within QS framework, works under consultative direction. Determines and pursues course of action necessary to obtain desire results.
• May supervise/lead Project Managers
• May function as Program Manager

Quality Duties and Responsibilities

• Ensure projects are executed following QS requirements and applicable procedures
• Maintain project metrics and reporting for management reviews.
• Support client and regulatory audits and follow-up
• Ensure any complaints are filed
• Support CAPAs as needed for quality and process improvements.

Marketing Duties and Responsibilities

• Participate in prospective client meetings
• Provide project schedule, resource, and budget information as needed to support creation of proposals.
• Identifie opportunities to offer additional services to clients during project engagements.

Qualifications & Skills

• Bachelor’s degree in a related field strongly preferred. MBA or Advance degree preferred for Senior PM and above
• Experience in medical device, clinical, regulatory or related field and required years of experience in Project Management:

Role

Project Management Experience

Project Manager

3+

Senior Project Manager

5+

Principal Project Manager

8+

• Mastery of project management tools, processes, practices and procedures
• CAPM or PMP certification preferred (required for Principal PM)
• Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Procedures (GMP) preferred (required for Principal PM)

Proficient with MS Project or similar and SharePoint
 

Technical Competencies

• Ability to understand and navigate the complexity of multiple moving activities, competing priorities, and limited resources
• Flexible and transparent, able to build trust with the team
• Ability to persuasively influence client and internal stakeholders to ensure high quality deliverables are completed on time and budget
• Strong verbal and written communications 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 translate complex problems to be easily understandable
• Understanding of project financials and impact to the business
• Understanding of technical project components and impact on other technical project areas
• Ability to work in a highly matrixed team environment
• Ability to train and mentor others.

Working Conditions

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms.  The employee must occasionally lift and/or move up to 25 pounds (12 kgs). 
• Extensive use of a computer keyboard.
• Travel approximately 10% of time.

Working Conditions:

•    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•    While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds (12 kgs).
•    Extensive use of a computer keyboard.
•    Travel approximately 10% of time.