Senior Project Manager

Description

The Senior Project Manager is responsible for planning, executing, and delivering complex cross-functional projects that support New Technology Development (NTD), New Product Introduction (NPI), and manufacturing process improvements. This role focuses on individual project leadership, ensuring milestones, timelines, risks, resources, and communications are effectively managed.

Job Duties/Responsibilities

• Develop, drive, track and report on integrated program plans, detailed project schedules, critical path analysis, project and product risks, and program deliverables.
• Coordinate activities and resources across multiple departments, including Operations, Customer Operations, Manufacturing, Marketing, R&D, Quality, Clinical, and Regulatory Affairs.
• Support project budget development and track project-related expenses, capital needs, and forecasting.
• Monitor actuals versus budget and escalate variances as needed.
• Support PMO department development and deployment of robust governance and processes to initiate, execute and track progress of GT Medical Technology projects. Support development and management of resource allocation tools.
• Demonstrate ability, confidence, and strong communication skills to lead project, and status meetings with internal cross-functional teams, external partners, and senior executives.
• Provide guidance on priorities, scheduling, and resolution of open issues, while maintaining compliance in a regulated product development environment.
• Work directly with corporate partners, consultants, vendors, and customers, as appropriate.
• Consult and provide advice, facilitate discussions, and resolve conflict; establish trust; build and use cross-functional relationships to accomplish work objectives.
• Adheres to the Company’s purpose operating principles, building a positive and productive team culture.
• Comply with Company policies and procedures.
• Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
• Other duties as assigned.

Requirements

• BS degree in Project Management, Engineering, Life Sciences, or related field.
• Minimum 5–8 years of project management experience in medical device, pharmaceutical, biotech, or similarly regulated industry.
• Project Management Professional (PMP) preferred, but not required.
• Ability to establish business cases within a project in consultation with business partners.
• Familiarity with key FDA medical device regulations (IEC 62304, ISO 14971, ISO 13485).
• In-depth knowledge of the product development process and medical device design control requirements, including a working knowledge of GMP’s and ISO standards.
• Ability to lead, collaborate, challenge and influence peers, subordinates, and senior management.
• Demonstrated ability to manage external partner relationships.
• Ability to prepare for and lead technical reviews and decision meetings. Can clearly document options and trade-offs to facilitate problem solving.
• Self-accountable for flawless project execution.
• Demonstrate clear bias for action and a sense of urgency.
• Demonstrated ability to successfully influence people and teams at levels without direct authority.
• Demonstrated analytical, decision making, prioritization and problem-solving skills.
• Experience interfacing with international companies and regulations preferred.
• Ability to manage multiple priorities.
• Ability to analyze and interpret scientific and statistical data.
• Follow all safety rules and safety procedures.
• Ability to understand federal and state regulations and company policies and procedures related to radiation safety.
• Excellent written and verbal communication skills.
• Proficient in using Microsoft office programs (Word, Excel and PowerPoint)
• Proficient in using MS Project and Visio.
• Willingness to work a flexible schedule.
• Able to travel for work as needed.
• Satisfactorily pass comprehensive background screening.

Physical Demands/Working Conditions

• Typical work environment for a professional office and home office space and occasionally works in a laboratory, supply room, and/or clean room environment.
• Occasional exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
• Largely a stationary role with some moving from place to place.
• Constant use of a computer, keyboard, mouse, monitor and other office equipment.
• Occasional use of laboratory equipment.
• Requires some finite hand/eye coordination.
• Occasionally picks up, carries, and moves items up to 30 lbs.
• Some evening and weekend work depending upon workload.
• Some overnight travel will be required for work, events, and training.