Project Manager R&D - Wayne, NJ
Date: Mar 20, 2025
Location: Wayne, NJ, US
Company: Datascope Corp.
Remote Work: 1-2 days
Salary Range: 115,000-145,000 + 10% STIP
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview:
The Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment and market launching of medical devices. Project assignment is at the discretion of the supervisor and is based on business requirements. Responsible for all phases of the project, from Concept Development to Product Launch. Develop project timelines, assemble required project teams, track the schedule & deliverables, & maintain effective communication throughout the project. Also responsible for project managing the end-to-end implementation of FSCAs.
Job Responsibilities and Essential Duties
Lead a cross-functional team in managing and executing projects 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 report
Manage a project within standardized methods and project models
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 with internal procedures
Understanding of group dynamics to influence team members
Develop and present regular status reports
Effective communication with project stakeholders, local management, and global management
Demonstrate leadership when facing uncertainty
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
Communicate project status at defined intervals and escalate any concerns to the Supervisor and associated Management representatives
Minimum Requirements
BS in Engineering discipline (e.g., Systems, Biomedical, Electrical, Chemical or Software Engineering) or equivalent experience
Minimum of 4+ years of experience in medical device or other regulated industry
Minimum of 3+ years in project lead role
Minimum of 3+ years in project management role
Experience in commercial operations or market launch a plus
Domestic and/or international travel up to 10%
Required Knowledge, Skills, and Abilities
Medical Device experience including thorough understanding of Medical Devi ce 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, 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, collaboration, verbal, and written communication skills; strong technical writing skills
Well organized, detail oriented
Task oriented and driven to complete assignments on schedule
PMP certification a plus
Must have the ability to effectively interface with both technical and non-technical personnel and with senior leaders
115,000-145,000 + 10% STIP
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About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
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. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.