Project Manager, R&D - Wayne, NJ

Getinge•Wayne, NJ

About The Position

The Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use catheters. 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 and drive project timelines, assemble required project teams, track 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 3+ years in project lead role or project management role
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; must be 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.
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.

Nice To Haves

experience in medical device or other regulated industry.
Domestic and/or international travel up to 20%

Responsibilities

Lead cross-functional project teams in support of Class I - III medical devices.
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.
Develop and present periodic status reports.
Effective communication with project stakeholders, local management, and global management
Demonstrate leadership when facing uncertainty.
Understanding of group dynamics to influence team members and lead the project.
Instill confidence through leadership and actions.
Identify, support, and promote new concepts and initiatives related to Project Management within the organization.