R&D Project Manager

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Company: Getinge
Location: Wayne, NJ 07470

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R&D Project Manager

Wayne, NJ

Together we can make a Difference!

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

The Project Manager will be responsible for the leadership of multiple projects related to material compliance of medical devices related to Cardiac Assist and Cardiac Surgery. The Project Manager will develop project timelines, assemble required project teams, track the schedule and deliverables, and maintain effective communication throughout the project. The Project Manager ensures quality and on-time completion of all projects. The role requires an individual with strong organization, communication and technical writing skills, with the ability to effectively interface with both technical and non-technical personnel.

The Project Manager is responsible for setting policy and strategy for evaluating medical devices to ensure they will meet applicable regulations and Directives related to material compliance. The Project Manager will also assess new and emerging requirements and recommend material compliance strategies to management to avoid disruption of trade.

Job Details:

  • Lead a cross-functional team in managing and executing projects in support of the material compliance of Class I – III medical devices
  • Monitor and maintain awareness of new and current product regulations and standards related to material compliance
  • Develop and release all project-related deliverables, including project plan, schedule and report
  • Manage a project within standardized methods and project models, including Waterfall and 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
  • Effective communication with project stakeholders
  • Demonstrate leadership when facing uncertainty & instill confidence through leadership and actions
  • Manage special and/or confidential projects at the discretion of the Managing Director, CTO or CEO

Background Experience:

  • BS in Engineering discipline (e.g., Systems, Biomedical, Electrical, or Software Engineering)
  • Minimum of 6+ years of experience in medical device or other regulated industry
  • Minimum of 3+ years in task or project lead role
  • Minimum of 3+ years working with product regulations and standards related to material compliance
  • Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
  • Knowledge of ISO 10993 series
  • Knowledge of product regulations and standards such as EU MDR, RoHS, REACH and WEEE
  • Directives, China RoHS, GHS, CA Proposition 65, TSCA, IATA, Dangerous Goods Transport and ISO 14001.
  • Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables
  • Domestic and/or International travel up to 20%

Interested candidates please submit your resume!

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.

INDNM

Job Type: Full-time

Work authorization:

  • United States (Required)