Project Manager

Getinge•Wayne, NJ

33d•$116,000 - $140,000

About The Position

The Project Manager will be responsible but not limited to the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use devices and/or CAPAs. Project assignment is at the discretion of the supervisor and is based on business requirements. Also responsible for all phases of the project, from Concept Development to Product Launch. Develop project timelines, assemble required project teams, track the schedule and deliverables, and maintain effective communication throughout the project.

Requirements

BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience.
Minimum of 4+ years of experience in medical device or other regulated industry
Minimum of 3+ years in task or project lead role
Domestic and/or international travel up to 20%
Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables
Experience with Microsoft Project, JIRA, Antura or other project management software
Experience in leading tasks/projects through a structured, phase-gate process
Lead and manage technical meetings with cross-functional members
Excellent interpersonal, verbal, and written communication skills; strong technical writing skills
Well organized, detail oriented
Task oriented and driven to complete assignments on schedule
Must have the ability to effectively interface with both technical and non-technical personnel.

Responsibilities

Lead cross-functional project teams in support of Class I - III medical devices and/or CAPAs
Monitor and maintain awareness of new and current product regulations and standards
Develop and release all project-related deliverables, including project plan, schedule, and budget
Manage a project within standardized methods and project models such as Waterfall or Agile
Lead and support execution of technical and/or cross-functional project work
Ensure the timely release of critical deliverables within the project
Ensure all aspects of the project are in compliance to internal procedures
Understanding of group dynamics to influence team members
Develop and present periodic status reports
Effective communication with project stakeholders, local management, and global management
Demonstrate leadership when facing uncertainty
Instill confidence through leadership and actions
Understand group dynamics and use this knowledge to lead the project
Identify, support, and promote new concepts and initiatives related to Project Management within the organization