Project Manager, Operations - Wayne, Nj

Job Overview

The Project Manager will be responsible for the leadership of complex cross-functional projects related to the production and/or sustainment of single use and electro-mechanical medical device systems with embedded software. The Project Manager is also responsible to drive all phases of the project, from Concept and Initiation to Project Close as well as escalate issues or concerns in a timely matter as needed to ensure success. In these phases, the Project Manager is required to develop project timelines and budget estimates, assemble required project teams, track the schedule, cost and deliverables, and maintain effective communication throughout the project. In addition, the Project Manager shall develop and utilize data analytics and visualization methods to track progress and escalate issues.

Job Responsibilities And Essential Duties

• Develop and present monthly status reports across the organization
• Understand group dynamics and use this knowledge to lead the project
• Manage a project within standardized methods and project models, including Waterfall and Agile
• Develop and release all project-related deliverables, including project plan, work breakdown structure, schedule, budget and report
• Demonstrate leadership when facing uncertainty
• Ability to track project progress via multiple methods (Kanban, Action/Decision Log, Data Analytics, Visualization e.g.)
• Lead a cross-functional team in managing and executing projects in support of Class I - III medical devices
• Ensure all aspects of the project are in compliance to internal procedures
• Instill confidence through leadership and actions
• Manage special and/or confidential projects at the discretion of the Vice President or CEO
• Ensure the timely release of critical deliverables within the project
• Effective communication with project stakeholders, local management, and global management.
• Monitor and maintain awareness of new and current product regulations and standards
• Identify, support, and promote new concepts and initiatives related to Project Management within the organization
• Communicate project status at defined intervals and meetings, and escalate any concerns to the Supervisor and associated Management representatives.
• Lead and support execution of technical and/or cross-functional project work
• Understanding of group dynamics to influence remote and in-person team members

Minimum Requirements

• Domestic and/or International travel up to 10%
• Minimum of 4+ years of experience in medical device or other regulated industry
• Minimum of 3+ years in task or project lead role
• BS in Engineering discipline (e.g., Systems, Biomedical, Electrical, Chemical or Software Engineering) or equivalent experience

Required Knowledge, Skills And Abilities

• Experience in leading tasks/projects through a structured, phase-gate process
• Must have the ability to effectively interface with both technical and non-technical personnel
• Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables
• Experience with Microsoft Project and other project management software, such as SharePoint, Power BI, Azure Data Factory, Alteryx, and Tableau
• Lead and manage technical meetings with cross-functional members
• Well organized and detail oriented
• Excellent interpersonal, verbal, and written communication skills; strong technical writing skills
• Task oriented and driven to complete assignments on schedule
• Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)

Salary Range: $95 - 125k

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.